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

Customized & flexible

  • Outsource all or part of your antibody manufacturing

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 kilogram

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.