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BPAI to speak with one of our bioprocess consultants who are experts in pharmaceutical outsourcing. We can help provide ensure that you are evaluating leaders in the biologics manufacturing industry. For more details please call Bio-Processing Alliance at (905-636-6559) or visit us at http://bioprocessingalliance.com/.

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Previously, I discussed data normalization of the proposal information, short listing, and the process of qualifying a shortlisted service provider. In this final blog on pharmaceutical outsourcing, I am going to focus on the quality audit, the contract review process, and project kick-off.

An important aspect when selecting a service provider is ensuring that their experience is aligned with the needs of the program. For development-based projects, the focus usually ends up being on personnel experience, laboratory capability, and company track-record with similar programs. For GMP biomanufacturing programs, however, a key item to schedule during the pre-contract award phase is the quality audit. Why, you ask? According to the International Conference on Harmonization (ICH) Q7 for Good Manufacturing Practice, "Contract manufacturers should be evaluated by the contract giver to ensure GMP compliance of the specific operations occurring at the contract sites." Accordingly, BPAI recommends performing the quality audit prior to contract award (as part of qualifying the shortlisted companies), so it is clear that the service provider is demonstrating the required principles and practices of compliance with respect to GMP. Once demonstrated, this clears any doubts when moving into the contract award phase, and ensures that any critical observations are highlighted prior to contract award so that the service provider is committed to a resolution before undertaking GMP activities. After all, there is nothing more negatively impacting to the project timelines than awarding a contract to a service provider, only to find out afterwards that the service provider is unable or unwilling to adjust internal practices to reduce program risks or comply with GMPs.

Typically, the audit phase of the contract award will involve 1-2 auditors for 1-2 days and will encompass a general review of the quality systems, as well as the facility, including a tour conducted in the order of product flow - from warehousing, to materials management, development laboratories, quality control, and biologics manufacturing suites. The aim of the audit is to obtain a general impression of the quality systems, their maturity, and the overall commitment to compliance. The outcome of the audit typically involves the publishing of an audit report that cites observational findings that need to be addressed depending on severity. Severity of the observations that can range from recommendations (which are simply helpful tips), to minor/major/critical. Critical observations may require updates to SOPs, addressing misalignment with regulations, re-establishing facility flow, addressing monitoring issues, or issues with training programs. It is advisable to have a written commitment from the service provider that they will address the observations, along with a plan and timeline for doing so. Finally, where technology transferand biologics process development are precursor activities to GMP biomanufacturing, a tour of the development laboratories can be extremely helpful in assessing the capability of the lab, even though development activities are typically not within the scope of a GMP compliance quality audit.

Contract negotiation can (and should!) proceed in parallel to scheduling and conducting the quality audit, as these activities typically involves a different subset of personnel and always take longer than anticipated. Negotiations can be a lengthy process, depending on the scope of the project and the overall cost of the program. BPAI recommends budgeting a minimum of 4-6 weeks of lead-time to finalize and sign a contract that involves GMP biomanufacturing. Most contracts include not only the overarching Master Services Agreement, but also appendices that outline specific Statements of Work, special conditions, product specifications, and the quality agreement. An important element to contract finalization is ensuring that a quality agreement is also established as a material part of the main services agreement, as this will ensure that the roles, responsibilities, and expectations of GMP compliance during program execution have been discussed/negotiated and agreed upon by the parties.

Critical elements of a pharmaceutical outsourcing contract should include:

Outline and scheduling of the services.

Payment schedule, including any deposits required and details on how deposits will be applied.

Project management assignments by both parties.

Establishment of a steering committee, and mechanism of escalation when issues arise.

Clear guidelines around permissibility (or lack thereof) and guidelines for subcontracting.

Regulatory reporting and maintenance requirements for each party.

Materials and outsourced testing costs and handling requirements.

Change order process.

Dispute resolution.

Guidelines for postponement or cancellation of laboratory or biomanufacturing services, as well as termination requirements.

Insurance requirements.

Confidentiality and intellectual property requirements.

Warranties by each party, as well as indemnification.

Of course, this is not an exhaustive list and within each of these sections there are many details, but the important part of having a written contract is to ensure that both parties agree on how services will be performed, monitored, and governed. BPAI recommends engaging with legal counsel and industry experts who have experience in the biologics manufacturing and pharmaceutical outsourcing industries before committing to the agreement.

With the contract and quality agreement signed, and a statement of work finalized that outlines the scope and deliverables of the project, you're now ready for the project kick-off phase. Over the years, our bioprocess consultants have seen an increasing trend in conducting project kick-off meetings in person, typically at the service provider's facility. The reason for this is simple - particularly for complex programs - seeing is believing, and meeting face to face is a critical element in defining early success of the project during the initiation phase. The project kick-off meeting provides an opportunity for key members of both party's execution teams to review the contract and statement of work together, establish a communication strategy, discuss the roll-out plan for the biomanufacturing project, review the timelines, and identify issues or out-of-scope items that may become apparent while mapping out the execution phase of the project. There are typically countless action items resulting from a project kick-off meeting! In addition, this meeting format provides an ideal opportunity for counterparts from each organization to meet one another in-person, and have the occasion to discuss specifics related to their area of the project. Finally, attendance at the project kick-off meeting typically defines the project team (comprised of members from both organizations) that will be meeting on a routine, on-going schedule to discuss the project execution and track overall progress. While it is not imperative to conduct the meeting in-person, BPAI has observed clear benefits in doing so because of the opportunity that it affords by clarifying roles and expectations during the technology transfer and early project initiation phase of the project.

In summary, my three-part blog on pharmaceutical outsourcing practices has touched on the following important aspects to consider when conducting an RFP process to select a service provider:

Do your research on what service providers are out there.

Establish the Confidentiality Agreement.

Develop and publish the Request for Proposal, with clear scope and deadlines..

Receive the proposals and normalize the data to achieve a 'like-for-like' comparison.

Shortlist the most interesting companies for further discussion.

Qualify the shortlisted companies through a site visit and sharing of contract documents.

Conduct a quality audit.

Negotiate the master services and quality agreements in preparation for signing.

Schedule the project kick-off meeting.

This wraps up my series on pharmaceutical outsourcing practices based on BPAI's experiences. As always, if you or your company are challenged with managing a complicated RFP process, I would highly encourage you to contact us at BPAI to speak with one of our bioprocess consultants who are experts in pharmaceutical outsourcing. This is a mainstay of our business

And we know it well. We can help provide you with a path towards selecting the ideal service provider, clarity in the process, and guidance to ensure that you are evaluating leaders in the biologics manufacturing industry.

Terry Cochrane
Managing Director
Bio-Processing Alliance, Inc.

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Pharmaceutical Outsourcing - Running a Tight Request for Proposal Process Part - 3

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Previously, I discussed data normalization of the proposal information, short listing, and the process of qualifying a shortlisted service provider. In this final blog on pharmaceutical outsourcing, I am going to focus on the quality audit, the contract review process, and project kick-off.

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At Bio Processing Alliance, our biologics consulting team that’s committed to helping your business through every stage of your project. For more details please call BPAI at (905-636-6559) or visit us at http://bioprocessingalliance.com/.

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Contact Us for Any Bioprocessing Assistance - BPAI

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Engage with our biologics consulting experts at BPAI. You will receive customized professional service that is focused on your specific goals & objectives.

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Bioprocess Technology Consultants | Request for Assistance

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Bioprocess Technology Consultants | Request for Assistance

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Our team provides effective assistance to bioprocess technology consultants, BPAI here to help! Use the online form to send us a customer assistance request. Contact Bio-Processing Alliance at (905) 636-6559 or visit us online at http://bioprocessingalliance.com/.

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Bioprocess Technology Consultants | Request for Assistance

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Need assistance with biologics consulting services, we are world's leading consultant for biomanufacturing, biologics & biosimilar companies worldwide.

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Bioprocess Consultants experts in pharmaceutical outsourcing can help provide you with a path towards selecting the ideal service provider. For more details please call Bio-Processing Alliance at (905-636-6559) or visit us at http://bioprocessingalliance.com/.

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In my last blog, I began discussing the front-end of the Request for Proposal (RFP) process that is typical in pharmaceutical outsourcing: research, confidentiality, publishing the RFP, and establishing clear deadlines. In Part 2 of this blog, I am going to discuss data normalization of the proposal information, shortlisting, and the process of qualifying a short-listed service provider.

The data normalization process can be quite tedious depending on the size of the program you are looking to outsource. More simple programs, such as a biologics process development project, can be easier to compare between service providers in contrast to a full biologics manufacturing program. However, even in the simplest of RFP processes, it is always a good idea to tabulate key data points into a spreadsheet to compare and contrast information gathered between service providers. The process of normalizing the proposal information allows for an apples-to-apples comparison between service providers, ensuring similar scope is being quoted and reviewed, and that base assumptions around costing is captured. In certain situations, you may find that additional correspondence with the service provider is necessary to better define a quoted activity so that you have a clearer comparison between service providers. Typically, our Bioprocess Consultants will generate a spreadsheet that captures information on 1) the service provider's business history and track record, 2) certain quality related information that may be critical to GMP biomanufacturing project (based on a quality questionnaire published as an appendix to the RFP), 3) costing information against scope/activities, and finally special terms and conditions. It is critical that a thorough read of the assumptions, and terms and conditions sections of each proposal is performed to ensure that you are clear on what is included and excluded from the proposal.

With the comparison spreadsheet in hand, and a relatively clear apples-to-apples comparison between service providers complete, it then becomes easier to use the tabulated data to make shortlist decisions. In more complex programs, or when there are many service providers, it can sometimes be useful to take the tabulated data and create graphs and charts to better assess the landscape of responses to the RFP. In one RFP process BPAI ran where the program included technology transfer through to GMP biomanufacturing, there were twenty global service providers that submitted proposals, which created a much too complex data set to merely rely on tabulated data to make a shortlisting decision on. The key point here is - use the appropriate tools available to help in shortlisting.

Shortlisting, or the decision to trim down the number of 'interesting candidates' to continue discussions with, should be based on the key parameters that are important in your selection process - which will vary in priority by company and situation - but will invariably include some of these typical attributes (in no particular order): cost, track-record, quality, location, timeline. BPAI Bioprocess Consultants recommend shortlisting down to at least 2 - 3 service provider candidates at minimum, provided that you have enough proposals in-hand to begin with. The purpose for shortlisting is to be able to focus your efforts on qualifying a few service providers to a much greater degree of granularity.

With 2 - 3 service providers shortlisted, the qualification process typically begins with sharing of template contracts, and if the program requires GMP biologics manufacturing, also the template quality agreement. Additionally, site visits are typically performed at the service provider's sites to meet the business and technical teams, review the facilities and generally 'kick the tires' to help make the best award decision possible. During site visits, it is typical to entertain technical discussions about how the program would potentially be transferred into the service provider's facility, as well beginning the discussion on any process adaptations or optimizations that may be necessary for the process to be successfully transferred. At this stage in the selection process, it is critical that you feel comfortable with the service provider's capability, understand the facilities and how the process would operate therein, and that there is a good meshing of the technical and quality experts from both sides.

The question of "when is the best time to perform a quality audit - before or after contract signing?" comes up often. recommends that If the program is earlier stage and has significant biologics process development activities that must be achieved before there is the possibility of progressing to GMP biomanufacturing, then it is usually okay to proceed into a development contract without performing a quality audit upfront. Conversely, for full GMP biologics manufacturing programs that have constrained timelines and are anticipated to move at a fast pace, it is ideal to perform the quality audit ahead of contract signing to ensure that the quality system is understood, that no surprises regarding compliance will occur when getting ready for GMP biologics manufacturing, and that any possible compliance concerns are addressable before signing the contract. Regardless of when you decide to perform a quality audit of your service provider, BPAI always recommends that you perform the audit well ahead of GMP biologics manufacturing to allow for runway to address any concerns.

Coming out of the qualification process, you'll have a good idea of the strengths and weaknesses of the shortlisted service provider candidates, which should allow for a data-driven and informed decision on which service provider to advance to final discussions with. So, how do you let the other service providers know? Once a decision to go to exclusive negotiations with a single service provider occurs, I always like to touch base with the other shortlisted companies to give them an update. The update can range from, "We've selected a different service provider because of ....", to "We're entering exclusive negotiations and would like to keep you as a backup in case there are issues in closing the contract". It is usually a good idea to have at least one backup company selected, just in case during final negotiations things occur that prevent closing. In any event, I urge you to be honest with the service providers throughout the selection process - for their benefit and for yours.

For the third part of this blog, I will be discussing the quality audit, contract review, and the very important activity of project kick-off.

In the meanwhile, if you or your company are being challenged with managing a complicated RFP process, I would highly encourage you to contact us at BPAI to speak with one of our Bioprocess Consultants who are experts in pharmaceutical outsourcing. This is a mainstay of our business, and we know it well. We can help provide you with a path towards selecting the ideal service provider, clarity in the process, and guidance to ensure that you are evaluating leaders in the biologics manufacturing field.

Until next time.....happy outsourcing!

Terry Cochrane
Managing Director
Bio-Processing Alliance, Inc.

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Pharmaceutical Outsourcing - Running a Tight Request for Proposal Process Part -2

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In my last blog, I began discussing the front-end of the Request for Proposal (RFP) process that is typical in pharmaceutical outsourcing: research, confidentiality, publishing the RFP, and establishing clear deadlines. In Part 2 of this blog, I am going to discuss data normalization of the proposal information, shortlisting, and the process of qualifying a short-listed service provider.

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Contact BPAI to speak with one of our Bioprocess Consultants, who are experts in pharmaceutical outsourcing. We can provide guidance to ensure that you are evaluating leaders in the biologics manufacturing field. Visit http://bioprocessingalliance.com/

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With the continued trend of increased outsourcing in the biopharma industry, a significant level of importance is being placed on the Request for Proposal (RFP) process. This makes sense - without a systematic approach to developing the RFP, soliciting bids from service providers, and then normalizing the bid information into a comprehensive package, it is possible to get muddled during contract award. Over the years, Bio-Processing Alliance has run more than 40 RFP processes, amounting to more than $40 million dollars in awarded contracts through our pharmaceutical outsourcing service.

Through this extensive experience, we have created an outsourcing selection system that is suitable for the solicitation of proposals for contracts ranging in services from limited biologics process development, through to full programs requiring technology transfer, process and analytical development, cell banking, scale-up and GMP biologics manufacturing, including process validation in preparation for commercial launch.

So, what has our experience taught us over the years? Well, first and foremost, it is critical to do your research on what service providers out there can provide the solution you're looking for. This can be a tedious part of the process if you have not run RFP processes previously, but for BPAI it is a matter of accessing our extensive database from years of pharmaceutical outsourcing experience. Once you have collected an assemblage of possible service providers, the 'contact us' stage of the process begins where initial contact is made and progress towards signing Confidentiality Agreements (CDA) occurs. As an aside, our Bioprocess Consultants would always recommend that as part of any RFP process there are CDAs executed prior to publishing the RFP. This is to protect the rights of the sponsor and the intellectual property in play.

Once the CDA is in place, you're ready to publish the RFP. A question we're often asked is how detailed does the RFP need to be, which is a great question! In BPAI 's experience, the more technical details that can be shared in the RFP, the more accurate and representative the proposals will be. After all, the reason a CDA is established ahead of publishing the RFP is to allow for a free exchange of information between the sponsor and the service provider, with the aim of tightening up the proposals to prevent incorrect costing or scope creep later in the process. Additionally, the RFP is such a critical document in the overall process that we recommend starting its creation very early in the RFP process, well ahead of making the first contact with the service providers.

When the RFP is finally published to all your service providers, you can sit back and take it easy, right? Not! It is always beneficial in the RFP to allow for the service providers to get in touch with you during their proposal generation phase regarding any questions they may have. Our Bioprocess Consultants at BPAI are typically very busy during this phase of the RFP process, fielding email questions and arranging conference calls to ensure that each of the service providers clearly understand the scope which they are bidding on, as well as the current state of the program. As a common theme in the RFP process, the more information and collaboration on information between the service provider and sponsor, the more accurate you can expect the proposal.

Another critical element in managing the overall pharmaceutical outsourcing process through the RFP is to establish very clear deadlines by which all service providers must have their proposals submitted. In our RFP templates, we usually have a section dedicated to the anticipated timeline of the overall RFP process, clearly delineating dates when the RFP will be published, when we will be fielding requests for further information, when the proposals are due, and when we approximately think the top candidates will be short-listed for further discussion. Obviously, there will always be situations requiring extensions and other requests, but the goal of the deadlines is to try to corral as many of the proposals as possible in hand at a specific date.

In our next blog, I will be discussing how to review and normalize all the information that comes in from the proposals, the short-listing process and how to communicate successful (or not so successful) short-listing decisions to the service providers, as well as the qualification process leading to the selection of a single service provider for more in-depth discussions.

In the meanwhile, if you or your company are being challenged with managing a complicated RFP process, I would highly encourage you to contact BPAI to speak with one of our Bioprocess Consultants, who are experts in pharmaceutical outsourcing. This is a mainstay of our business and we know it well. We can help provide you with a path towards selecting the ideal service provider, clarify the process, and provide guidance to ensure that you are evaluating leaders in the biologics manufacturing field.

Until next time.....happy outsourcing!
Terry Cochrane
Managing Director
Bio-Processing Alliance, Inc.

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Pharmaceutical Outsourcing - Running a Tight Request for Proposal Process | BPAI

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With the continued trend of increased outsourcing in the biopharma industry, a significant level of importance is being placed on the Request for Proposal (RFP) process. This makes sense - without a systematic approach to developing the RFP, soliciting bids from service providers, and then normalizing the bid information into a comprehensive package, it is possible to get muddled during contract award.

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Are you looking for Biologics Manufacturing Services? BPAI offers biologics consulting and biopharmaceutical manufacturing services. Contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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Bio-Processing Alliance Inc. (BPAI) provides biologics consulting services and solutions to leading biomanufacturing, biologics, and biosimilar companies worldwide.

Established in 2010, we have a proven track record through delivery of countless client programs spanning the globe. We enhance company value, and offer a competitive advantage with our vast biologics consulting and biopharmaceutical manufacturing expertise.

The BPAI team are bioprocess technology consultants who share a common goal - to improve and support the management of biologics programs; from concept through to biologics process development and GMP biomanufacturing. Our clients trust us to successfully deliver GMP products for use in Phase 1 - 3 human clinical trials by using our extensive bioprocessing experience to manage their biopharmaceutical manufacturing programs, efficiently and effectively.

Our comprehensive biologics consulting services include:

When you engage with our biologics consulting experts at BPAI you will receive customized professional service that is focused on your specific goals and objectives. We value your company, we value your ideas, and we value your business.

CONTACT US to get the results you need.

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A consulting services for Bio Manufacturers, Biologics & Biosimilars

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Bio-Processing Alliance Inc. (BPAI) provides biologics consulting services and solutions to leading biomanufacturing, biologics, and biosimilar companies worldwide. Established in 2010, we have a proven track record through delivery of countless client programs spanning the globe. We enhance company value, and offer a competitive advantage with our vast biologics consulting and biopharmaceutical manufacturing expertise.

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Bio Processing Alliance, Inc. (BPAI) has biologics experts can provide support and assist you using our innovative pharmaceutical outsourcing services.Contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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In the last seven years, Bio Processing Alliance, Inc. (BPAI) has established itself as a leader in the biologics consulting business. Since the company's inception, our commitment has been to enhance our client's company value by awarding and effectively delivering, biopharma development and manufacturing programs all over the world in support of clinical and commercial phase products. If you are just learning about our company, here are four things we want you to know about working with Bio-Processing Alliance.

We're Experienced: Not only do we have years of experience under our belts, but within our network we are also connected with a multitude of individuals that have extensive biologics consulting and biopharmaceutical manufacturing expertise. This depth and breadth of professional experience enables us to bring holistic support in the management of entire biologics programs - from concept to vial. We take pride in the fact that our clients trust us to successfully deliver GMP clinical and commercial stage products because of our successful track-record in managing biopharma manufacturing programs, efficiently and effectively.

We Do More: It's not just one service we provide that can help your company succeed. We're pleased to offer support and value to clients in several areas:

Pharmaceutical Outsourcing Management: Our systematic approach can help you select the ideal contract service provider. Our RFP process is uniquely tailored to your program, which makes final selection decisions clear, concise and simple. Regardless of where you are in the RFP process, BPAI's biologics experts can provide support and assist you using our innovative pharmaceutical outsourcing services.

Technical Program Management: Whether your needs relate to technology transfer, development or scale-up, our company offers a wide range of support services that can help you deliver your CMC biologics program in a reasonable time and within a sensible budget.

Business Management: BPAI biologics consulting experts can offer customized, professional service that leads you to achieve your specific corporate goals and objectives. Whether it is a review of work-flow efficiency, reviewing quality systems, or establishing new business systems for delivery of programs, BPAI has the expertise and knowledge to enhance your success.

We Value Your Business: We firmly believe that your success is our success, which is the cornerstone of our business. We will listen to your ideas and your goals and do our best to make sure we add value to your business. We proudly share testimonials on our website as we've worked hard to ensure that our clients are satisfied with both our work product and level of collaboration.

We're Innovative: Our industry is continually changing, advancing, and getting better. Our business practices mirror our industry's continual improvement philosophy. We have innovative ideas to help improve the delivery of services in our field. To this end, we have developed an innovative service called Bio-Process[TRIAGE] that helps our clients effectively troubleshoot bioprocessing problems, failures or other issues associated with biologics process development, scale-up, GMP bio manufacturing or quality investigations.

We are a results driven organization that thrives on achieving success for our clients. If you would like to learn more about how we could work together, we invite you to contact us at 905-636-6559. BPAI is ready to take on new challenges and opportunities, and looks forward to hearing from organizations that have identified needs and are ready to act.

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4 Things You Need To Know About Bio Processing Alliance

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In the last seven years, Bio Processing Alliance, Inc. (BPAI) has established itself as a leader in the biologics consulting business. Since the company's inception, our commitment has been to enhance our client's company value by awarding and effectively delivering, biopharma development and manufacturing programs all over the world in support of clinical and commercial phase products.

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BPAI’s team of bioprocess consultants is a great partner. They matched our commitment to rapidly and cost-effectively advance our product. To know more contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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"BPAI's team of bioprocess consultants is a great partner. They matched our commitment to rapidly and cost-effectively advance our product into clinical trials and brought tremendous industry experience, technology insight and disciplined execution to our complex biologics manufacturing program through their strategic pharmaceutical outsourcing management."

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Our program provides financial support to businesses and individuals that conduct SR&ED in Canada. Bioprocess consultants offers Scientific Research & Experimental Development with Research Tax Services Ltd. Contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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BPAI offers Scientific Research & Experimental Development (SR&ED) claim preparation in partnership with Research Tax Services Ltd.

What are Scientific Research and Experimental Development (SR&ED) Income Tax Credits?

The program provides financial support to businesses and individuals that conduct SR&ED in Canada. In many cases, the credits are refundable, i.e. you will receive a cheque from CRA.

How do I qualify?

Have you:

Fashioned a new product?

Improved an existing product?

Developed or improved a process?

Improved or changed the way your products are manufactured?

Built a prototype?

Evaluated a new relationship between two or more variables?

If you answered yes to any of the above, you may qualify.

For Canadian Controlled Private Corporations (CCPC)
Investment Tax Credits (ITC) are earned at 35% on the first $2 million of eligible expenses, 20% thereafter.

Individuals and partnerships:
20% of eligible expenses earn a tax credit.

SR&ED capital expenditures can be depreciated entirely in the year of their purchase.

Non-refundable tax credits can be carried back 3 years and carried forward 10 years to off-set Part I federal income tax.

Retro-active claim period:
Claims can be submitted up to 18 months from a fiscal year end.

It is often possible to apply for a Pre-Claim Project Review, which will provide some surety of claim acceptance.

What expenditures qualify?

labour

materials

contract payments

overhead costs

third party payments

some lease costs for R&D equipment

capital expenditures where at least 50% of the usage is for SR&ED

How will you be paid?

CCPC:

Current expenditures: 100% refundable tax credits

Capital expenditures: 40% refundable tax credits

Individuals and Partnerships

What we will do:

Discuss your project informally to provide professional advice about whether your project will qualify.

Interview your staff to identify projects that may meet CRA eligibility criteria so we can prepare technical documentation.

Identify all the costs associated with the projects to prepare the tax forms.

Prepare all the technical and financial prescribed forms for you and work with your accountant to ensure the forms are properly handled.

Coach your staff to collect the required data

Assist you in the event of an eligibility review by CRA

What do you have to do?

Verbally describe your project

Collect your financial records together (receipts or general ledger)

Sign the forms

No Risk Fees

Contingency-based fees eliminate financial risk and ease cash flow uncertainties to your company. We only get paid IF and WHEN you do.

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Scientific Research & Experimental Development (SR & ED)

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BPAI offers Scientific Research & Experimental Development (SR&ED) claim preparation in partnership with Research Tax Services Ltd. The program provides financial support to businesses and individuals that conduct SR&ED in Canada. In many cases, the credits are refundable, i.e. you will receive a cheque from CRA. Have you: Fashioned a new product?

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BPAI biologics consulting experts offers customized, professional service that leads you to achieve your specific corporate goals and objectives. To know more contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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BPAI provides business management support services related to the biomanufacturing industry to assist your organization, whether it is a review of work-flow for efficiency, or helping to establish new business systems for delivery of programs, BPAI can assist you.

Project management support and systems development

Business development support:

Value proposition scouting

Biologics manufacturing overhead analysis

Pricing and margin analysis

Proposal drafting and review

Terms and conditions development

Statement of Work review

Business systems development and implementation

Work flow efficiency analysis

Request Assistance from our expert business management bioprocess consultants.

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bio manufacturing business support service

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Business Management Support Services - BPAI

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BPAI provides business management support services related to the biomanufacturing industry to assist your organization, whether it is a review of work-flow for efficiency, or helping to establish new business systems for delivery of programs, BPAI can assist you.

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Our biologics manufacturing support services are tailored to your organizations specific needs. Also, our bioprocess technology consultants can assist you in numerous areas. To know more contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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Technology Transfer with Guidance for Recombinant Protein

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BPAI has a successful record of accomplishment in technology transfer and scaling crude native or recombinant protein products ready for harvest and purification.

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Bio Processing Alliance, Inc. (BPAI) has established itself as a leader in the biologics consulting business by offering biologics process development and bio manufacturing programs all over the world in support of clinical and commercial phase products. Contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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In the last seven years, Bio Processing Alliance, Inc. (BPAI) has established itself as a leader in the biologics consulting business. Since the company's inception, our commitment has been to enhance our client's company value by awarding and effectively delivering,...

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Bioprocess Technology Consultants Archives - bioprocesing

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In the last seven years, Bio Processing Alliance, Inc. (BPAI) has established itself as a leader in the biologics consulting business. Since the company's inception, our commitment has been to enhance our client's company value by awarding and effectively delivering,...

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Biomanufacturing and Pharmaceutical outsourcing has seen a significant change as the industry has grown & matured. Catching up, BPAI has also developed a systematic approach towards it. Contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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In the biologics industry, many small or start-up companies lack the resources to perform all aspects of their business on their own. Even mid- or large-size companies don't always have the personnel, equipment, space, or bioprocess technology to carry out every step in the research, development, biomanufacturing and marketing chain that is required to take a new biologics drug candidate from preclinical research stages to clinical trial through to commercial licensing. The common solution is to rely on pharmaceutical outsourcing of these tasks to a service provider, particularly when biomanufacturing (biologics manufacturing) is involved, which allows for the channelling of precious financial resources into the new drug candidate instead of expensive biopharmaceutical manufacturing infrastructure.

Over the past 20 years, pharmaceutical outsourcing has seen a significant change as the industry has grown and matured. A decade ago, the drug industry backed away from the 'vertically integrated' business model that had been popular in the 1990's, and moved toward an outsourcing model. At that time, companies were receiving more funding, and their investment backers began to acknowledge the value that biologics manufacturing companies, and other outsourcing firms, added to new candidate products. At present day, with the biologics industry's maturation, we are witnessing more established operating strategies, evolving to suit the demands of biomanufacturing innovation. Approximately 50% of all biopharmaceutical companies are currently outsourcing some form of their biomanufacturing, and this growth trend is expected to continue in the coming years.

Given this growing trend, and the importance of pharmaceutical outsourcing in the biologics industry, BPAI has developed a systematic approach for managing Request for Proposal (RFP) processes that assists our clients in the selection of an ideal outsourced service provider - balancing program costs against biologics process development and GMP biomanufacturing timelines and risks. Our RFP process uniquely solicits critical, decision making information from service providers in a standardized way so that when the proposals are received they can be quickly normalized and presented in a logical and data driven way, making final selection decisions clear and simple. Services related to RFP processes include:

Creating a comprehensive statement of work for the program

Developing the Request for Proposal through an iterative, client-driven process

Establishing confidentiality agreements with candidate biologics manufacturing service providers

Negotiation and on-going dialogue to assist service providers in publishing a meaningful proposal

Normalization of submitted proposals, with graphical and tabulated data presentation

Qualification of short-listed service providers

Navigation assistance for final selection decisions

Over the years, BPAI has worked as biologics consultants to award more than $40 million dollars in biomanufacturing programs globally on behalf of our clients, and have assisted with the technical program management on nearly all of these following contract awards.

Whether you're just starting an RFP process, are in the middle of one, or are struggling with numerous proposals, let BPAI's biologics experts assist you through our innovative pharmaceutical outsourcing services.

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In the biologics industry, many small or start-up companies lack the resources to perform all aspects of their business on their own. Even mid- or large-size companies don't always have the personnel, equipment, space, or bioprocess technology to carry out every step in the research, development, biomanufacturing and marketing chain that is required to take a new biologics drug candidate from preclinical research stages to clinical trial through to commercial licensing.

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Biologics that is designed to help our clients quickly and effectively. BPAI can assist you to establish new business systems for delivery of programs. For more details please visit http://bioprocessingalliance.com/

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Triage [tree-ahzh] "the process of sorting victims (bioprocess failures) to determine medical priority (troubleshooting) in order to increase the number of survivors (chance of successful manufacture)"

BPAI has developed an innovative service called Bio-Process[TRIAGE]that is designed to help our clients quickly and effectively troubleshoot bioprocessing problems, failures or other issues associated with biologics process development, scale-up, GMP biomanufacturing or quality investigations. Request Assistance from BPAI's expert bioprocess consultants for typical bioprocessing issues:

Bioprocessing troubleshooting

Root-Cause investigation

Analytical and bioanalytical method review and troubleshooting

Biologics process scale-up failure

GMP biomanufacturing batch failure

Bioburden contamination problems

Data review, interpretation and recommendation

Process validation failure

Cleaning validation failure

Method validation failure

Quality or compliance concerns

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Bio Process Triage - Troubleshooting Solution by BPAI

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Triage [tree-ahzh] "the process of sorting victims (bioprocess failures) to determine medical priority (troubleshooting) in order to increase the number of survivors (chance of successful manufacture)" BPAI has developed an innovative service called Bio-Process[TRIAGE]that is designed to help our clients quickly and effectively troubleshoot bioprocessing problems, failures or other issues associated with biologics process development, scale-up, GMP biomanufacturing or quality investigations.

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Bio-Processing Alliance Inc. (BPAI) provides biologics consulting services and solutions to leading biopharmaceutical manufacturing, biologics. To know more contact us at 905-636-6559 or visit http://bioprocessingalliance.com/

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"BPAI's team of bioprocess consultants is a great partner. They matched our commitment to rapidly and cost-effectively advance our product into clinical trials and brought tremendous industry experience, technology insight and disciplined execution to our complex biologics manufacturing program through their strategic pharmaceutical outsourcing management."

Ilia Tikhomirov, CEO Formation Biologics

2017-02-10T02:02:36+00:00

Ilia Tikhomirov, CEO Formation Biologics

"BPAI's team of bioprocess consultants is a great partner. They matched our commitment to rapidly and cost-effectively advance our product into clinical trials and brought tremendous industry experience, technology insight and disciplined execution to our complex biologics manufacturing program through their strategic pharmaceutical outsourcing management."

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Bio-Processing Alliance Inc. - Biologics Process Consultant

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"BPAI's team of bioprocess consultants is a great partner. They matched our commitment to rapidly and cost-effectively advance our product into clinical trials and brought tremendous industry experience, technology insight and disciplined execution to our complex biologics manufacturing program through their strategic pharmaceutical outsourcing management."