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.)
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Up to Bio-Safety Level 2+ (BSL-2+) facilities for higher containment
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Result Oriented: Customization, flexibility, and transparency is key
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Global quality standards: Documentary/data support for regulatory filings
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Flexible partnership structure: Milestone or FTE/Retainership
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Team with extensive experience: Strong expertise and credibility in developing vaccines and biologics from early stages to commercial scale GMP manufacturing
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Capabilities to support broad spectrum of expression/technology platforms for novel product development: Mammalian Cell Culture; Insect Cell Culture; Microbial Fermentation
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Experience of developing monoclonal antibody (mAb), recombinant vaccine, and gene therapy products for global biotechnology companies
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Potential for expansion for later stage manufacturing
PROCESS DEVELOPMENT
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Cell line development
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Optimization and scale-up for high product titer, stability and consistent manufacturing output
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Upstream and Downstream Development
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Upstream manufacturing technologies and strategies know-how (eg. Bioreactors / fermenters, disposable systems, fed-batch, perfusion, expression kinetics)
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Downstream product harvest, recovery and purification methods such Centrifugation, tangential flow filtration (UF/DF), Depth filtration, Chromatography
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Analytical method development and qualification
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Stability studies
PROCESS
CHARACTERIZAITON
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Establishment and qualification of small-scale model for different unit operations for the process
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Classification of Process Parameters and Product Quality Attributes-Critical, Major, Minor
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Design of Experiments (DoE) to establish the appropriate Ranges for the Process Parameters and Product Quality Attributes
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Execution of experiments and generation of data/reports to support regulatory filings
GMP MANUFACTURING
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Cell and Virus seed banking
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Rocker, Stirred Tank and Adherent Cell Bioreactors
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Up to 1000L Stirred bioreactor scale
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Utilization of single-use (disposable) technologies
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Separate suites
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Non-infectious organisms
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Infectious organisms (BSL-2+)
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Fill/Finish On-Site: Aseptic Formulation, Fill & Finish (Lyophilization & Liquid in Vials)
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Stability Studies
ADDITIONAL SUPPORT OFFERED
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Third Party CRO management for outsourced activities and testing:
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Cloning and Cell line development
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Cell line and Virus bank characterization
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Release testing; safety, identity, strength, quality, purity
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Work with client QP to ensure compliance with EU/EMEA
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Short-term product storage;
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Product supply/distribution to study sites;
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Client support in regulatory filings and meetings with government agencies (USFDA, EMEA, etc.).
