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 200L Stirred bioreactor scale
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Utilization of single-use (disposable) technologies
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Two 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 (Liquid in Vials).
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.).
Document Control
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Approve Master Documents
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Standard Operating Procedures
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Material Specifications
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Product Specifications
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Batch Production Records
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Validation Protocols/Reports
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Issue Working Documents
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Executable forms and Batch Production Records
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Archive Documents/Records
Environment Control
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HVAC
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Grade D, C and B Cleanrooms
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Sterile Filtration/Filling in A/B
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BSL-2+ dedicated unit with single-pass air exchange
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Cleanroom qualification
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Environmental Monitoring
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Viable Particles
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Non-viable Particulates
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Cleaning
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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:
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Approved material
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Manufacturers and Suppliers
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Catalog numbers
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Grade
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Storage conditions
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Handling and disposal procedures.
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Equipment Control
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Maintain SOPs and Equipment History Files for all equipment used in manufacture or support of GMP product
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Qualification/Validation
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Calibration
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Maintenance
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Use
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Cleaning
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PROCESS 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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Assay development and qualification
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Stability studies
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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
PROCESS
CHARACTERIZAITON
QA Support Systems
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Personnel Training Program
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Deviation Reporting
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Out-of-Specification Investigation Management
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Corrective and Preventive Action Program
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Internal Audits
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Vendor Audits
Product Control
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Generate Product Specifications for all products manufactured under GMPs
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Review executed Batch Production Records and support documentation for compliance to GMPs, Internal procedures and batch record instructions
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Issue Certificates of Analysis with each GMP batch
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Prevent Cross Contamination
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Separate Production Areas for non-infectious and infectious production
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Area Clearance and Batch/Campaign Changeover Procedures
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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)
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Result Oriented: Customization and flexibility 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 based collaboration (depending on the project/scope)
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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 cell-culture/viral and microbial based systems
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Potential for expansion for later stage development and manufacturing