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.
