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Yapan Bio provides integrated services from early stage process development & scale-up to process characterization and GMP manufacturing for Clinical Studies

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  • Development and manufacturing of next generation and highly complex molecules/product classes (recombinant vaccines, viral and non-viral vector-based products, Gene Therapy, monoclonal antibodies etc.) 

  • Up to Bio-Safety Level 2+ (BSL-2+) facilities for higher containment

  • Result Oriented: Customization, flexibility, and transparency is key

  • Global quality standards: Documentary/data support for regulatory filings

  • Flexible partnership structure: Milestone or FTE/Retainership 

  • Team with extensive experience: Strong expertise and credibility in developing vaccines and biologics from early stages to commercial scale GMP manufacturing

  • Capabilities to support broad spectrum of expression/technology platforms for novel product development: Mammalian Cell Culture; Insect Cell Culture; Microbial Fermentation

  • Experience of developing monoclonal antibody (mAb), recombinant vaccine, and gene therapy products for global biotechnology companies

  • Potential for expansion for later stage manufacturing

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PROCESS DEVELOPMENT

  • Cell line development

  • Optimization and scale-up for high product titer, stability and consistent manufacturing output

  • Upstream and Downstream Development

    • Upstream manufacturing technologies and strategies know-how (eg. Bioreactors / fermenters, disposable systems, fed-batch, perfusion, expression kinetics)

    • Downstream product harvest, recovery and purification methods such Centrifugation, tangential flow filtration (UF/DF), Depth filtration, Chromatography

  • Analytical method development and qualification

  • Stability studies

PROCESS 

CHARACTERIZAITON

  • Establishment and qualification of small-scale model for different unit operations for the process

  • Classification of Process Parameters and Product Quality Attributes-Critical, Major, Minor

  • Design of Experiments (DoE) to establish the appropriate Ranges for the Process Parameters and Product Quality Attributes

  • Execution of experiments and generation of data/reports to support regulatory filings

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GMP MANUFACTURING

  • Cell and Virus seed banking

  • Rocker, Stirred Tank and Adherent Cell Bioreactors

  • Up to 1000L Stirred bioreactor scale

  • Utilization of single-use (disposable) technologies

  • Separate suites

    • Non-infectious organisms

    • Infectious organisms (BSL-2+)

  • Fill/Finish On-Site: Aseptic Formulation, Fill & Finish (Lyophilization & Liquid in Vials)

  • Stability Studies

ADDITIONAL SUPPORT OFFERED

  • Third Party CRO management for outsourced activities and testing:

  • Cloning and Cell line development

  • Cell line and Virus bank characterization

  • Release testing; safety, identity, strength, quality, purity

  • Work with client QP to ensure compliance with EU/EMEA

  • Short-term product storage;

  • Product supply/distribution to study sites;

  • Client support in regulatory filings and meetings with government agencies (USFDA, EMEA, etc.).

PROCESS DEVELOPMENT
PROCESS CHARACTERIZATION
GMP MANUFACTURING
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