One-stop GMP Contract Manufacturing of Biopharmaceuticals

Biomay offers fully integrated cGMP capacities for contract manufacturing of recombinant biomolecules

Recombinant proteins / microbial fermentation                     

  • Long track record
  • Rec. Cas9, allergens, antibodies, therapeutic proteins, etc.
  • Soluble or as inclusion bodies 

 Plasmid DNA / microbial fermentation  

  • Long track record 
  • Own process know how / technology
  • Plasmids as API, viral starting vectors (AAV), CAR-T, etc. 

 Platform for personalized batches plasmid DNA / batch size ~200-300 mg

  • Short lead time and high batch throughput meeting needs of personalized therapies
  • 3 weeks from transformation of starting plasmid to batch release
  • Optimized manufacturing process based on Biomay´s pDNA production platform 

mRNA / in-vitro transcription (IVT)

  •  Process including plasmid template, poly(A), capping, mRNA purification, and F&F
  •  GMP license granted
  •  Available GMP-grade   

 

Biomay is addressing clients who require mg to g quantities of active pharmaceutical ingredients (APIs) and drug products for clinical phases I – III. Biomay has positioned itself as a one-stop CDMO that offers a highly attractive price-performance ratio at a short project lead time.

 

The scope of Biomay´s CDMO services comprises:

  • Vector and host development  
  • cGMP cell banking
  • Tech-transfer and contract process development
  • cGMP manufacturing of API (drug substance)
  • cGMP manual aseptic filling of drug product
  • QC with a comprehensive set of validated assays
  • In-house QP batch release
  • Assay / process / cleaning validation
  • Long-term storage and stability testing
  • Regulatory support (CMC part of IMPD / IND)

 

Bioprocessing Expertise and GMP Capacities

Since more than 20 years, Biomay has gained expertise in manufacturing of recombinant biomolecules with microbial systems like E. coli. Biomay performes state-of-the-art bioprocessing technologies like high-cell density fed-batch fermentation, continuous centrifugation, homogenization, refolding, various chromatographies and ultra-diafiltration.

Biomay conducts a GMP quality management system in compliance with international standards and operates a fully integrated manufacturing facility certified according to EMA directives (2001/83/EC, 2001/20/EC). In two independent GMP suites, three controlled clean room classes are available: class D for upstream and recovery, C for downstream and A for aseptic formulation and filling.

 

 

If you have questions or would like to have a quote for pDNA services, please send an e-mail to request(at)biomay.com