Customized & flexible
- Outsource all or part of your antibody manufacturing
Contract manufacturing
Monoclonal antibody contract manufacturing service
As one of the world leaders in monoclonal antibody manufacturing, Medix Biochemica has developed an efficient process for in vitro production of monoclonal antibodies using perfusion technology by hollow fiber bioreactors and wave tanks.
Monoclonal antibody manufacturing offers customized contract manufacturing service that makes your antibody production effortless. The process includes evaluation and optimization through cell line adaptation, mycoplasma testing, production optimization and validation. We have a scalable production capacity from milligrams to kilograms with stringent quality control, full documentation and international quality standards which we continuously follow.
Adaptation & optimization
- Mycoplasma testing
- Production optimization
- Adaptation to serum- & protein-free media
Production
- Spinner bottle, wave tank & hollow fiber methods
- Scale mg–kg
- Customized options
Purification
- Affinity purification
- Protein A / G chromatography
- Validation batches
Quality controls & storage
- Immunoreactivity testing, OD 280, IEF, HPCL-SEC, CE
- Reference stock
- Master and working cell banks
Experience our customized antibody manufacturing service
Controlled
- In vitro production with uniform product quality from batch to batch
- Fully certified quality control systems by ISO 13485:2016 and FDA QSR
- Serum- and protein-free culture media
Cost-effective
- Streamlined process
- Can be scaled based on your needs – from milligrams to kilograms
Consistency and quality are at the center of our contract manufacturing process, so you can rely on us. Our promise to you is quality monoclonal antibody production, personalized, highly efficient technical support, and fast and reliable deliveries. Experience a worry-free outsourcing that complies with the most stringent quality requirements.
Native proteins and antigens
Our team understands how to use the various physical properties of proteins to not only purify, but also analyze and qualify a target product. To do this, our facilities use multiple unit operations to execute protocols as varied as the proteins themselves. Looking for a partner to execute your protocols or perform testing on your product?
Capabilities
- Small to large batches
- Scalability
- Animal and human sources
Unit Operations
- Extraction
- Clarification
- Chromatography
- Lyophilization
QC Support
- In process & release testing
- Stability testing
- Protocol execution
Techniques
- Content / identity
- Activity
- Purity
- pH / moisture
Discuss your needs with one of our team, please get in touch with us today.