Scope of GMP Contract Services

Biomay is a “one-stop-shop” for the supply of GMP-grade biopharmaceuticals for clinical studies. The following GMP contract services are offered:

• Contract cell banking
• Contract process development
• Contract manufacturing of drug substance (internal) / drug product (outsourced)
• Quality control and release testing
• Regulatory support

                 

Contract GMP Cell Banking

Biomay offers to clients following services for GMP cell bank production:

• Development and construction of expression vector and host
• cGMP production of Master and Working Cell Banks (MCB, WCB)
• Characterization and release testing
• Long-term stability monitoring
• Long-term storage (qualified and temperature monitored ultra deep freezers)
  
  

Contract Process Development

Biomay´s process scientists are skilled and experienced in the development of the whole biopharmaceutical process chain. Depending on the client´s needs, customized work packages can be offered:

• Process development, optimization and scale-up
• Formulation devlopment
• Production of material for non- or pre-clinical purposes
• Process validation
• Cleaning validation
• Analytical assay development
• Technology transfer from / to client 
       

Contract GMP Manufacturing

Biomay offers a GMP contract service for manufacturing of recombinant proteins and plasmids (DNA vaccines) used as active pharmaceutical ingredients (drug substance). Furthermore, Biomay also offers the manufacturing of drug product (aseptically filled and finished) via outsourcing to reliable contract partners.

The deliverables of a representative GMP manufacturing project would be: 

• Supply of cGMP drug substance and drug product for clinical studies (QP released, certificate of analysis, certificate of compliance)
• Technology transfer of manufacturing processes and analytical assays
• cGMP compliant documentation and reports (cell banking, development, manufacturing, quality control/release, stability)

Quality Control and Release Testing

Analytical release testing and in-process controls are included within a contact manufacturing arrangement. On client´s request, assay development and validation as well as product stability testing can be offered. Biomay´s QC methods comply with Ph.Eur. standards.

Following analytical methods are available:

• Electrophoresis: SDS-PAGE (coomassie / silver stained), Western blot
• Chromatography: RP-HPLC, IEC-HPLC, SEC
• Spectroscopy: UV, OD₆₀₀, MS, CD, dynamic light scattering
• Immunochemical methods: ELISA (product-specific or IgE-binding, host cell proteins, host cell DNA)
• Microbiological methods: bioburden, viability, phenotypic identification, plasmid retention
• Other (bio)chemical methods: peptide mapping, N-terminal sequencing, amino acid composition, DNA sequencing, restriction mapping, endotoxins, TOC, raw material testing.                           

                                                             
Most assays will be performed at Biomay by our internal QC staff. In addition, we cooperate with certified contract laboratories and our network partners in order to extend the list of analytical methods. Biomay employs a certified Qualified Person (QP) for release of drug substance and drug product.

Regulatory Support

Biomay offers regulatory assistance and guidance for its clients by giving support in writing the CMC part of the relevant filing documents (IMPD or IND). Meanwhile, Biomay has compiled the CMC section of several IMPDs for its own or its client´s clinical studies.

Realizing Contract Projects with Biomay

Biomay is  commited to deliver GMP-grade biopharmaceuticals with the highest possible quality. Biomay´s CMO projects are carried out by applying efficient project management principles. Meeting the client´s timelines and bringing his product as fast as possible to clinical validation is Biomay´s priority. Being able to start projects within a short lead time is one of our major strengths. Depending on individual client requirements, a typical CMO project will take  5 to 10 months from tech-transfer to supply of released GMP material.

Biomay is highly aware of the importance of a trustworthy project atmosphere, and we count on pro-active client interaction and open personal communication. For initiation of a CMO project, Biomay will make a proposal on client´s request, thereby addressing his individual needs. To conclude a contract, both Biomay and the client would negotiate and sign a manufacturing and quality agreement.

Please contact Dr. Hans Huber, Head of Production, for more details or questions on Biomay´s contract manufacturing services (h.huber(at)biomay.com / ++43-1-7966296-104).

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