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Commercial Operations provide manufacturing of protein therapeutics for clinical and commercial supply based on over 30 years' experience.
Manufacturing - cGMP & non-GMP
- Prokaryot
- Eukaryot
- Batch, Fed-batch & Perfusion
- Pre-clinical Phase
- Clinical Phase I-III
- Commercial Phase
QA/QC of Drug Substance & Drug Product
- Quality Assurance Release and Quality Control Testing
- Stability Studies
- Technical Reports and Documentation for Regulatory Filing
- Regularly inspected by FDA, EMEA and other Regulatory Authorities
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| Lena Nyström |
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”Inhouse QA/QC department guarantees the highest cGMP standards on supplied clinical and commercial drug product.”
Lena Nyström, Vice President and Head of Manufacturing
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| Facts |
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Biovitrum is the sole global manufacturer for Pfizer (formerly Wyeth) of the active protein substance in ReFacto AF®, used for treatment of hemophilia.
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