Ajinomoto Bio-Pharma Services

Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organisation, with sites in Belgium, the United States, Japan, and India, providing comprehensive process development services, cGMP manufacturing, and drug product fill finish services of small molecule and large molecule active pharmaceutical ingredients (APIs) and intermediates.

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Description

Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organisation, with sites in Belgium, the United States, Japan, and India, providing comprehensive process development services, cGMP manufacturing, and drug product fill finish services of small molecule and large molecule active pharmaceutical ingredients (APIs) and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities to rapidly scale from clinical and pilot programmes to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing, and more. The organisation is dedicated to providing a high level of quality and service to meet clients' needs.

Services include:
- Regulatory Services
- Containment
- APIs (Active Pharmaceutical Ingredients)
- Analytical Services
- Protein and Peptide
- Packaging
- Clinical Packaging
- Cell and Gene Therapy
- Injectables
- Clinical Dose
- Biologics
- Contract Development and Manufacturing (CDMO)
- Finished Dosage Forms
- Accelerated Stability Studies
- Aseptic Fill/Finish
- Assay Development
- Bioanalytical Services
- Biocatalysis
- Process Development
- Bioprocessing
- Disposable/Single-Use
- Biosimilars
- Cell Culture Media Development
- Chromatography
- Clean in Place / Sterilization in Place (CIP/SIP)
- Clinical Trials Management
- Chemistry (CMC)
- Manufacturing
- Cold Chain Management
- Contract Manufacturing (CMO)
- Distribution
- Clinical Trials
- Documentation Support Services
- Dosage Form Development
- Downstream Processing
- Drug Delivery Devices
- Drug Development
- Feasibility Studies
- Fermentation
- Filling
- Syringe
- Vials
- Forced Degradation Studies
- Formulation Development
- Lot Release Testing
- Lyophilization
- Bioequivalence
- Cartridge
- Clinical Trial Materials
- Controlled Substances
- Cytotoxic & High Potency Compounds
- Dose Form
- Sterile
- High Containment Operations
- Liquids
- Microbial-based Therapeutic Proteins
- Oligonucleotides
- Parenterals
- Large Volume
- Small Volume
- Peptides
- Proteins
- Solutions & Suspensions
- Sustained Release
- Pre-filled
- Vaccines
- Microbial Fermentation
- Aseptic Fill-Finish
- Glass
- Labelling
- Parenterals Development
- Pilot-Scale Filling
- Preclinical Testing Formulations
- Preformulation
- Process Characterization
- Process Validation Studies
- Protein Extraction/Purification
- Purification
- Scale-Up
- Stability Studies
- Stability
- ICH
- Sterile Filling
- Sterility Testing
- Sterilization
- Storage
- Sustained Release Delivery Systems
- Technology Transfer
- Validation
- Warehousing

Ajinomoto Bio-Pharma Services stands out as a leading provider within the pharmaceutical industry, ensuring consistent quality and reliability across their diverse offerings. For more information, please visit ajibio-pharma.com.

Certification
United States FDA, Canada Health Canada, UK MHRA, Europe EMA, Belgium FAMHP, Japan PMDA, ISO 14001

Capabilities

Contact Information

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