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1. Protein-based therapeutics
2. Vaccines
3. Peptide drugs
4. Nucleic acid-based drugs

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upstream processing: culture and maintenance of cells
downstream processing: chemical + physical separations and purifications from culture mixture

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- PEGylation
- proteinylaton
- protein sequence modification (site directed mutagenesis)

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- designated clean areas must be differentiated from designated dirty areas to minimize cross-contamination

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- dry waste and liquid waste container (must be able to be capped)
- items must be arranged so that it does not disrupt airflow

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packaging and storage of biopharmaceuticals

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packaging and storage of biopharmaceuticals

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packaging: smooth glass walls, dark opaque walls, air tight container, avoid usage of polystrene with sinlanyl/plasticizer coating
storage: freeze drying in low temp to prevent moisture, refrigeration

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parenteral, inhalation, oral, transdermal, gastrointestinal mucoadhesive patch

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Used to culture systems to produce cells/organisms or secondary metabolites.

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1. pH
2. temperature
3. nutrient supply
4. salt concentration
5. aeration/dissolved oxygen
6.sterility
7. anti-foaming

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- centrifugation
- size exclusion chromatography
- ion exchange chromatography
- protein affinity chromatography

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- single-use tool/device
- mostly pre-sterilized
- made of high quality plastic

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- in fixed-in-place, made up of stainless steel or glass

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1.Large and unstable molecules
2.Easily destroyed by the body
3.Specific storage conditions required
4.Weak bonds between molecules
5.Hard to obtain in large amounts