WHO WE ARE ARE
Ajinomoto Bio-Pharma Services is a fully integrated, global contract development and manufacturing organization providing comprehensive process development services, cGMP manu- facturing and drug product fill finish services of small molecule and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our clients’ needs and can support projects from preclinical through commercial production.
With locations in United States, Belgium, Japan, and India, we are focused on working in tandem to leverage our global infrastructure to provide adaptive solutions and responsive service to the biotechnology and pharmaceutical companies worldwide.
SERVICES OFFERED
Drug Product Manufacturing:
A leader in aseptic filling, offering a wide range of capabilities for vials and syringes from early stage clinical projects to larger scale commercial products.
• Formulation
• Aseptic Fill Finish
• Terminal Sterilization
Small Molecule Manufacturing:
Over 40 years of small molecule API and intermediate manufacturing for the pharmaceutical industry, using advanced technologies and chemistries.
• Lab & pilot scale facilities
• High potency API development and manufacturing (HPAPI)
• Cryogenic & high pressure reactions
• Biocatalysis
• Continuous flow technology
• High energy chemistries
Oligo & Peptide Synthesis:
An industry leader in the synthesis of high quality, scalable, custom oligonucleotides and peptides
• AjiPhase® Synthesis Technology
• Fast Solid Phase Synthesis
Large Molecule Manufacturing:
One of the industry’s top leaders in microbial biologic manufacturing, using patented technologies and providing impeccable quality. Specializing in plasmid manufacturing for over 25 years.
• cGMP Plasmid and Protein Production
• Microbial Cell Banking & Characterization
• Fermentation
• Purification & Formulation
• Corynex® Protein Expression System
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