Viral Vector Process Development and Manufacturing

Industry Leading Platform Enables Process Development and cGMP Manufacturing of Viral Vector Drug Product under 6 Months

Viral Vector Manufacturing

Accelerating your CMC journey for clinical and commercial Success

We offer a purpose-built facility specifically designed for Viral Vector manufacturing. Our processes adhere to stringent global regulatory guidelines, including FDA, EU, and NMPA standards. Additionally, our experienced team boasts over 20 years in development and GMP manufacturing of gene therapies.

Our Approach

  • Seasoned scientists drive development and manufacturing, aiming for commercialization.
  • Rigorous selection of raw materials and consumables based on quality, compliance, cost.
  • State-of-the-art analytical platforms speeds up product release.
  • Standardized, PD and GMP documents ensure compliance.
  • Extensive CMC Regulatory support

Additional Viral Vector Services

  • MCB / WCB Manufacturing and Cell Banking Services for HEK293,SF9 and others, including release and characterization.
  • HEK293 cell line is offered through CoJourney with straight forward licensing terms and fully transferable to other manufacturers.
  • Analytical Services including: BioAssay Development, Stability Testing, Reference Standard
  • Manufacturing Studies: Hold studies, Filter studies, End of Production Cell Bank
  • Regulatory support for CMC dossier

Upstream Process Development and Manufacturing

Process Development Scientists and Manufacturing Operators collaborate throughout the development and manufacturing process to ensure successful production.

Small Scale Optimization

  • Utilizes a design of experiments (DOE) approach
  • Optimizes process in flasks
  • Raw materials and consumables are stocked on-site to ensure operational readiness
  • Process development is designed to facilitate a smooth transition to GMP, encompassing aspects such as raw materials, documentation, testing and equipment.

Scale up from development to full-scale manufacture

  • Small scale pilot batches (2-10L)
  • Engineering runs (200L, 500L)
  • GMP manufacturing (200L, 500L)

* Scalability to 500L while consistently maintaining product quality, and productivity from PD to Pilot scale to GMP. CoJourney has successfully executed multiple runs at the 500L scale.

Downstream Process Development and Manufacturing

Process Design & Development

  • DOE to achieve high yield and purity using affinity, ion exchange, multi-modal chromatography steps
  • Use bead-based, membrane absorption, and monolith
  • Process characterization

GMP Purification

  • Single use flow path, dedicated chromatography system
  • Automated chromatography methods
  • UFDF for all scales, single-use platform
  • Centrifugal separations using custom designed, single use collection apparatus

Scalable AAV And LVV Manufacturing Platform

Partnering with you through every step of the development process, from benchtop optimization to full-scale GMP manufacturing and finishing.

  • Filling System is automated within in an Isolator with a filling capacity of 1600 vials per lot. Standard vial configurations have been prequalified.
  • In-process monitoring, and QC samples are taken throughout the process
  • Critical Equipment, Raw materials, and consumables are readily available on-site.

Development and cGMP Manufacturing of Plasmids, Viral Vector DS and DP within 6 months using our platform for AAV and LVV.​

  • Our well characterized platform increases reproducibility and accelerates CMC timelines while ensuring quality.
  • Parameters are fine tuned through DOE studies to improve yield and quality of your product.
  • GMP plasmid production is manufactured on the CoJourney campus, minimizing risks to plasmid sourcing.
  • Tox material can be completed in five months. cGMP drug product can be completed within 6 months.
  • GMP raw materials are stocked on-site to ensure operational readiness.
  • Analytical methods have been qualified for the platform
  • Customized processes available

Viral Vector Platform Assays are readily available to be adapted to your program.

  • In-process monitoring and sampling performed throughout manufacturing process
  • GMP QC labs perform DS and DP in-process and batch release testing on-site
  • QC Team routinely ensures compliance with evolving regulatory requirements
  • Other Analytical / QC Services Include
    • In-house Stability testing under various conditions
    • Reference Standard generation and qualification from development or at-scale runs
    • Characterization and Analytical Comparability
    • Method Development / Qualification / Validation
    • Method Optimization for transferred methods not aligned with current standards

Our Services

Scalable, high quality production of pre-clinical to GMP grade viral vectors

CoJourney’s viral vector platform is specifically designed to maximize yields, increase scalability, and produce viral vectors of the highest quality. Our industry leading, serum free suspension platform delivers upstream yields of up to 1×1012 viral genomes per ml (vg/ml), utilizing a HEK293 triple plasmid co-transfection process. Programs employing this process have obtained IND approval from both the FDA and NMPA. Please download our brochure for more information about our plasmid, viral, vector and testing services.

Ready to get started?

Let’s discuss ways to optimize production of your viral vector.