Recombinant Proteins
Production of recombinant proteins expressed with microbial systems has been Biomay’s focus since its foundation. We are recombinant protein experts, since more than three decades. In view of GMP contract manufacturing, Biomay has gained broad expertise in with a big variety of recombinant proteins during the past 15 years.
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.
