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GMP MANUFACTURING

  • Cell and Virus seed banking

  • Rocker, Stirred Tank and Adherent Cell Bioreactors

  • Up to 200L Stirred bioreactor scale

  • Utilization of single-use (disposable) technologies

  • Two separate suites

    • Non-infectious organisms

    • Infectious organisms (BSL-2+)

  • Fill/Finish on site - Aseptic formulation/fill/finish (Liquid in Vials).

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.).

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Document Control

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  • Approve Master Documents

    • Standard Operating Procedures

    • Material Specifications

    • Product Specifications

    • Batch Production Records

    • Validation Protocols/Reports

  • Issue Working Documents

    • Executable forms and Batch Production Records

  • Archive Documents/Records

Environment Control

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  • HVAC

    • Grade D, C and B Cleanrooms

    • Sterile Filtration/Filling in A/B

    • BSL-2+ dedicated unit with single-pass air exchange

    • Cleanroom qualification

  • Environmental Monitoring

    • Viable Particles

    • Non-viable Particulates

  • Cleaning

    • Alternating disinfectants

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QUALITY

Material Control

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  • Generate Material Specifications for all components used in manufacture of GMP material, which identifies:

    • Approved material

    • Manufacturers and Suppliers

    • Catalog numbers

    • Grade

    • Storage conditions

    • Handling and disposal procedures.

Equipment Control

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  • Maintain SOPs and Equipment History Files for all equipment used in manufacture or support of GMP product

    • Qualification/Validation

    • Calibration

    • Maintenance

    • Use

    • Cleaning

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PROCESS 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

  • Assay development and qualification

  • Stability studies

 

  • 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

PROCESS 

CHARACTERIZAITON

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QA Support Systems

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  • Personnel Training Program

  • Deviation Reporting

  • Out-of-Specification Investigation Management

  • Corrective and Preventive Action Program

  • Internal Audits

  • Vendor Audits

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Product Control

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  • Generate Product Specifications for all products manufactured under GMPs

  • Review executed Batch Production Records and support documentation for compliance to GMPs, Internal procedures and batch record instructions

  • Issue Certificates of Analysis with each GMP batch

  • Prevent Cross Contamination

    • Separate Production Areas for non-infectious and infectious production

    • Area Clearance and Batch/Campaign Changeover Procedures

  • Change Control

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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  • Niche capabilities: Custom Development and Manufacturing for high containment requirement products (BSL-2+ containment)

  • Result Oriented: Customization and flexibility is key

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

  • Flexible partnership structure: Milestone or FTE based collaboration (depending on the project/scope)

  • 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 cell-culture/viral and microbial based systems

  • Potential for expansion for later stage development and manufacturing