Develop and scale your process
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.
Access state-of-the-art antibody or recombinant protein capabilities
Our capabilities include:
- 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
- Analytical method development/optimization and qualification/validation to support commercial filings including ELISA and bioassay
- Process transfer, optimization, characterization/qualification/validation and viral clearance, pilot-scale manufacturing
- cGMP clinical and commercial manufacturing release testing and regulatory writing services
- Reference standard characterization and product stability studies
Our locations
Locations where this service is provided
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Regulatory expertise
Pathway to success in Regulatory filings
Extensive Regulatory Expertise
We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.
Dedicated Regulatory Affairs Contact
We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.
Keep Pace with Regulatory Thinking
Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.
Biologics
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