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.

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 Handheld Raman Analyzer

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

TruScan™ RM Handheld Raman Analyzer

microPHAZIR™ RX Analyzer

8. Filled vessel capped and sealed

Versa Rx Checkweigher for Pharmaceutical Applications

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

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

TruScan™ RM Handheld Raman Analyzer

microPHAZIR™ RX Analyzer

IonicX Portable XRF Analyzer

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 Handheld Raman Analyzer

microPHAZIR™ RX Analyzer

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.

Cell Flow Path

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 Handheld Raman Analyzer

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

TruScan™ RM Handheld Raman Analyzer

microPHAZIR™ RX Analyzer

8. Filled vessel capped and sealed

Versa Rx Checkweigher for Pharmaceutical Applications

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

Cell Culture Media

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

TruScan™ RM Handheld Raman Analyzer

microPHAZIR™ RX Analyzer

IonicX Portable XRF Analyzer

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.

Buffers

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

TruScan™ RM Handheld Raman Analyzer

microPHAZIR™ RX Analyzer

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.

Sterilization

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.