Product Name
Protein Production Services offers cGMP Production ServiceOrganization name
Protein Production ServicesURL
http://www.pps.co.ilProfile
Protein Production Services (PPS) is your partner for cGMP contract manufacturing services.
Our streamlined cGMP compliant technological platform offers a comprehensive package to our clients all the way to Phase I and II bulk API. PPS provides process development including gene expression in E. coli, mammalian cells and yeast; small scale production, purification, analytical methods and formulation development; scale up and cGMP manufacturing for research, preclinical and clinical use.
Our regulatory affairs support includes QP release and preparation of CMC dossier, as well as support of technology transfer. cGMP production includes establishment and characterization of Master Cell Bank and Working Cell Bank, fermentation, protein purification and lyophilization in clean rooms, bulk API and formulation, QC and QA. Our expertise includes production of antibodies and glycoanalysis with a local partner.
We ensure that customer milestones are reached. As former employees of InterPharm (SERONO), our team has extensive experience in all aspects of manufacturing. We put our vast experience to the benefit of our clients, from gene expression all the way to cGMP production, technology transfer and regulatory affairs support.
Process development services include:
- Gene expression
- Small scale production
- Purification
- Analytical methods
- Formulation
- Scale up
- Technology Transfer
- Regulatory affairs support
- cGMP Process adaptation
- cGMP production
- Quality Control
- Quality Assurance
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