Recombinant Proteins

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

Long track-record in recombinant proteins

Biomay has been dedicated to manufacturing of recombinant proteins since the company was founded in 1984, and has gained expertise in GMP contract manufacturing of a large variety of recombinant proteins during the last 10 years.

This includes:

  • Functional proteins relevant for the gene therapy field such as recombinant Cas9    
  • Single-chain Antibodies
  • Therapeutic proteins as APIs of vaccines
  • Recombinant allergens and allergen derivatives for allergy immunotherapy

 

Our manufacturing platform comprises state-of-the-art bioprocessing technologies like high-cell density fed-batch fermentation, continuous centrifugation, homogenization, refolding, various chromatographies and ultra-diafiltration.

Expression systems: We primarily offer E. coli as expression system; In addition, the capacities and know-how for processing of other bacterial hosts or yeasts like Pichia pastoris are available.

Experience and know-how covers soluble proteins as well as proteins expressed in inclusion bodies requiring refolding. 

  

One-stop shop for your clinical trial material

We are 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 for recombinant proteins comprises:

  • Vector and host development
  • cGMP cell banking (MCB, WCB)
  • 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)