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LSM Process Map

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.

Prima PRO Process Mass Spectrometer

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.

TruScan RM

7. API received and ID confirmed. Formulation and sterile fill to vials, syringes or cassettes. Final fill may be lyophilized.

TruScan RM
TruScan RM

8. Filled vessel capped and sealed

TruScan RM

9. Product stored at correct temperature before transfer to customer.

1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.

TruScan RM
TruScan RM

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.

Prima PRO Process Mass Spectrometer

5. Cells harvested.

1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.

TruScan RM
TruScan RM

2. Buffer preparation, mixing, and sterilization.


3. Cell growth (lag, log, steady, decline) Batch, fed batch, continuous fermentation.

Prima PRO Process Mass Spectrometer

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.

Prima PRO Process Mass Spectrometer

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.

TruScan RM

7. API received and ID confirmed. Formulation and sterile fill to vials, syringes or cassettes. Final fill may be lyophilized.

TruScan RM
TruScan RM

8. Filled vessel capped and sealed

TruScan RM

9. Product stored at correct temperature before transfer to customer.

1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.

TruScan RM
TruScan RM

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.

Prima PRO Process Mass Spectrometer

5. Cells harvested.

1. Raw Materials arrive at warehouse: media, buffers, resins, etc. authenticated/verified.

TruScan RM
TruScan RM

2. Buffer preparation, mixing, and sterilization.


3. Cell growth (lag, log, steady, decline) Batch, fed batch, continuous fermentation.

Prima PRO Process Mass Spectrometer

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.