We have extensive experience in expressing, developing and manufacturing antibodies and recombinant proteins for use as targeting agents or carrier proteins for bioconjugates. Let us simplify your supply chain by manufacturing all intermediates as well as your bioconjugate drug.
The current targeting agent of choice for Antibody-Drug Conjugates (ADCs) is an intact antibody. Our experts in mammalian manufacturing begin the process by using our proprietary expression systems to produce and purify the antibody of choice which is designed for stochastic (random) or site-specific conjugation.
If an antibody fragment (Fab), single-chain variable fragment (scFv), or peptide aptamer is required for your targeting agent or carrier protein, our mammalian or microbial manufacturing team is ready to develop and scale your process.
Our Antibody or Recombinant Protein Capabilities:
- Protein engineering, humanization, immunogenicity and manufacturing assessment. LightPath™ discovery (non-GMP protein expression using GS System® vectors)
- Cell line or bank engineering (incl. expression vectors for site selective conjugation) cell line development, banking and stability LightPath™ development
- Process transfer, optimization, characterization/qualification/validation and viral clearance, pilot scale manufacturing
- Analytical method development/optimization and qualification/validation to support commercial filings including ELISA and bioassay
- Reference standard characterization and product stability studies
- cGMP clinical and commercial manufacturing release testing and regulatory writing services