Search Thermo Fisher Scientific
- Order Status
- Quick Order
-
Don't have an account ? Create Account
Biologics Workflow and Process Map for Pharmaceutical and Biotech Manufacturing
From raw material identification through the pharmaceutical manufacturing process, to finished and packaged pharmaceutical product inspection, our solutions help pharmaceutical and biopharmaceutical manufacturers save time, improve processes, protect brand integrity, and ensure patient safety.
1. Cell bank development of production cell line.
2. Seed train growth and preparation for fermentation, or cell culture.
3. Cell growth (lag, log, steady, decline). Batch/fed batch/continuous fermentation.
4. Cells harvested.
5. Product extracted through lysis, recovery, clarification, purification, polishing, and buffer exchange stages.
6. API is sterilized and prepared for transfer to fill and finish site.
7. API received and ID confirmed. Formulation and sterile fill to vials, syringes or cassettes. Final fill may be lyophilized.
8. Filled vessel capped and sealed
9. Product stored at correct temperature before transfer to customer.
1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.
2. Cell culture media preparation, dispensing, mixing, formulation, sterilization, and incubation.
3. Seed train growth and preparation for fermentation, or cell culture.
4. Cell growth (lag, log, steady, decline) Batch, fed batch, continuous fermentation.
5. Cells harvested.
1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.
2. Buffer preparation, mixing, and sterilization.
3. Cell growth (lag, log, steady, decline) Batch, fed batch, continuous fermentation.
4. Product extracted through lysis, recovery, clarification, purification, polishing, and buffer exchange stages.
1. Buffer preparation, mixing, and sterilization.
2. Cleaning and sterilization to approved SOP.
3. Cells harvested.
4. Formulation and sterile fills to vials, syringes or cassettes.
5. Cell culture media – preparation, dispensing, mixing, formulation, sterilization, and incubation.
1. Cell bank development of production cell line.
2. Seed train growth and preparation for fermentation, or cell culture.
3. Cell growth (lag, log, steady, decline). Batch/fed batch/continuous fermentation.
4. Cells harvested.
5. Product extracted through lysis, recovery, clarification, purification, polishing, and buffer exchange stages.
6. API is sterilized and prepared for transfer to fill and finish site.
7. API received and ID confirmed. Formulation and sterile fill to vials, syringes or cassettes. Final fill may be lyophilized.
8. Filled vessel capped and sealed
9. Product stored at correct temperature before transfer to customer.
1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.
2. Cell culture media preparation, dispensing, mixing, formulation, sterilization, and incubation.
3. Seed train growth and preparation for fermentation, or cell culture.
4. Cell growth (lag, log, steady, decline) Batch, fed batch, continuous fermentation.
5. Cells harvested.
1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.
2. Buffer preparation, mixing, and sterilization.
3. Cell growth (lag, log, steady, decline) Batch, fed batch, continuous fermentation.
4. Product extracted through lysis, recovery, clarification, purification, polishing, and buffer exchange stages.
1. Buffer preparation, mixing, and sterilization.
2. Cleaning and sterilization to approved SOP.
3. Cells harvested.
4. Formulation and sterile fills to vials, syringes or cassettes.
5. Cell culture media – preparation, dispensing, mixing, formulation, sterilization, and incubation.
CMD SchemaApp code