Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization, with sites in Wetteren and Balen, Belgium and San Diego, California, USA, providing comprehensive process development services, cGMP manufacturing and drug product fill finish services of small molecule and biologic APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities to rapidly scale from clinical and pilot programs to commercial quantities, including: Corynex technologies, oglionucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client’s needs.
Services Offered
Large Molecule Manufacturing:
One of the industry’s top leaders in microbial biologic manufacturing, using patented technologies and providing impeccable quality
• cGMP Protein and Plasmid Production
• Microbial Cell Banking & Characterization
• Fermentation & Product Recovery
• Purification & Formulation
• Corynex ® Protein Expression System
Highly Potent & ADC Services:
Ajinomoto Bio-Pharma Services offers dedicated production and laboratory suites for high containment ADC bioconjugates and highly potent compounds, as well as formulation and fill finish services
• Conjugation & Purification
• Fill & Finish
• Lyophilization
• Dedicated labs and manufacturing
Oligo & Peptide Synthesis:
An industry leader in the synthesis of high quality, scalable, custom oligonucleotides and peptides
• AjiPhase ® Synthesis Technology
• Fast Solid Phase Synthesis
Drug Product Manufacturing:
A leader in aseptic filling, offering a wide range of capabilities for vials and syringes
• Aseptic Formulation
• Aseptic Fill Finish
• Packaging, Serialization & Aggregation Services
Development Services:
Our highly knowledgeable Process Development team will establish and characterize a robust manufacturing process to ensure consistent cGMP manufacturing performance
• Process Development
• Optimization & Scale Up
Product Quality & Analytical Services:
Our well-designed product quality and analytical programs work to ensure the success of your small and large molecule products through their life cycle
• On-Site Laboratories
• Phase Appropriate Analytical Method Development & Lot Release Testing
• ICH – Compliant Stability Programs