Recombinant Proteins

Biomay offers end-to-end services for GMP manufacturing and testing of messenger RNA and template DNA. At the company’s mRNA Competence Center, we operate our in-house developed platform for in-vitro transcription and mRNA processing.

Expertise in Proteins

Our track-record in recombinant protein GMP manufacturing includes:

  • Proteins as active ingredients for therapy and vaccination
  • Gene editing components, such as recombinant nuclease Cas9
  • Antibody derivatives like single-chain Fv fragments (scFv)
  • Allergens and allergen derivatives (allergy immunotherapeutics)

Biomay is a one-stop CDMO for recombinant proteins. Our protein services include:

  •  Expression plasmid development (design, codon optimization, construction)
  • Process development, feasibility studies, tech-transfer
  • Analytical assay development
  • cGMP cell banking (MCB/WCB plus testing, release, storage)
  • cGMP manufacturing of API (drug substance)
  • cGMP aseptic filling of drug product (automated or manual)
  • QC with a comprehensive set of validated assays
  • In-house QP batch release
  • ICH stability testing
  • Regulatory support (e.g. CMC part of IMPD / IND)

Escherichia coli is our workhorse for recombinant protein expression

Expression systems: We primarily apply Escherichia coli as expression system. In addition, other bacterial hosts or yeasts like Pichia pastoris can be processed.

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

Capacities and technical features for recombinant protein GMP manufacturing:​

  • Expression as soluble protein or inclusion-bodies (IBs)
  • High-cell density fed-batch fermentation
  • Fully scalable range of bioreactor capacities: 30L, 50L, 150L and 750L
  • Mechanical high-pressure homogenizers for cell disruption at various scales
  • Inclusion body refolding at various scales (tank capacities up to 2000 L)
  • Process chromatography and tangential flow filtration (TFF) at various scales
  • Batch size from 100 mg to 500 g protein
  • Process free of animal components, antibiotics, organic solvents
  • Generic and protein-specific quality control methods

Related Services

From sequence to product

Biomay is your one-stop-shop for GMP manufacturing services.