Protein Manufacturing: Recombinant Protein Production
More than 35-years track record in GMP production of proteins
CDMO partner from Clinical trial to commercial supply of protein products
- Protein manufacturing in Bacteria and Yeast
- 60% of projects are protein-based
- Broad and comprehensive portfolio of in-house analytical services including Bioassays
- One-Stop-Shop services: from gene to finished product
Recombinant proteins manufactured
- Antibody variants: VHH and Nanobodies, FAB
- Secreted, periplasmic and insoluble proteins
- Enzymes
- Peptides
DRUG SUBSTANCE DEVELOPMENT & GMP MANUFACTURING
From gene of interest to product, we flexibly manufacture your target molecule
- Strain development
- Cell bank production (RCB, MCB/WCB)
- Process- and analytical method development
- Tech-transfer of existing methods
- Product-specific quality control (IPC, DS, DP)
- GMP-compliant manufacturing in up to 1,000 L scale
- Clinical trial to commercial supply
- Project management
Partner of choice for manufacture of proteins
PRODUCTION FACILITIES
Flexibility makes the difference.
- Two independent multiproduct GMP facilities
- Fermenter volumes from 10 - 1,000 L
- Different scales available
- Tech transfer of external processes possible
- Additional capacity from mid of 2024 onwards
- Cell bank production (RCB and MCB / WCB )
-
Technologies and equipment for pDNA manufacturing in various
scales as required - Independent USP and DSP trains
- Flexible DSP scales / scalable lysis
Know your molecule
In addition to the assays listed, we provide further assays and custom developed procedures to meet your requirements.
KEY Parameter
Suggested Method
- Product-related impurities
- cIEF, CE and SDS-PAGE (reducing and non-red.)
- Purity
- RP-HPLC
- Insoluble particles
- SEC-HPLC
- Content
- UV280
- Residual Host Cell DNA
- qPCR
- Residual Host Cell Proteins
- ELISA
- Endotoxins
- Kinetic-LAL
- Bioburden
- USP/EP
Our Protein Services
GMP
- Established and validated generic QC testing for proteins
- Establishment of reference standards
- Supportive stability studies
- Comparability studies
- Regulatory compliant method transfer if requested
- Formal stability studies (ICH)
- Cell bank characterization and stability testing
- storage of product according to customer request
- Release of material performed by QP in house
Summary
EXPERTISE
- Strong track record in microbial production
- More than 35 years of experience in GMP production of proteins
- Trustful and continued customer relationships
FACILITIES
- GMP facilities approved by int. authorities
- Flexible production capabilities
- Extension of capacities for protein projects in progress
CUSTOMER SERVICE
- Project Management
- Supportive consultancy for protein projects
- One-Stop-Shop services for Drug Substance and Drug Product
- Audited by major authorities including but not limited to FDA, EMA, PMDA
This might interest you
25 years of experience with pDNA projects. Audited by major authorities including but not limited to FDA, EMA, PMDA.
The product types manufactured with microbial expression systems at Richter-Helm BioLogics include recombinant proteins and peptides, antibody-like scaffolds (VHH/Nanobodies, Fab-fragments), plasmid DNA, and bacterial vaccines.
