GI Partners Acquires CDMO and Cell Solutions
As Rose BioSolutions, the established CDMO and Cell Solutions businesses continue to support the biotechnology ecosystem with cell sourcing capabilities and CDMO services to accelerate your advanced therapy from development to delivery.
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In Safe Hands: Keep your Gene Therapy Program On Track
Viruses are the dominant vectors used in gene therapies. Manufacturing of viral vectors is a complex process; to avoid costly and time-consuming delays it requires the highest levels of expertise, and accuracy. Likewise, successful viral vector technology transfer requires significant know how, precision, and a methodical approach that minimizes program impact and ensures confidence around continuity of supply.
We leverage decades of viral vector contract development and manufacturing organization (CDMO) experience to ensure that every aspect of your gene therapy technology transfer is managed meticulously – from initial knowledge transfer and gap assessment through to GMP production, with regulatory support available to meet your specific needs.
Offering Fast Track and Modular frameworks to facilitate project continuity for advanced therapy developers, keep your critical production schedule on track and safeguard your supply with Charles River.
Speak to an expert to discuss the best route to tech transfer your viral vector program
Modular and Fast Track Viral Vector Technology Transfer
Our viral vector technology transfer process is carefully designed to align with your specific objectives and ensure a successful transition. Specialized teams, including process and analytical development experts, engage closely with you to understand and integrate your project goals into every step. We utilize standardized protocols and effective risk management strategies across all operations.
Our templated documentation streamlines data collection, ensuring accuracy and consistency across departments. We also develop a comprehensive technology transfer roadmap detailing methodologies, quality standards, and regulatory requirements to mitigate risks and clarify all project stages. This structured approach enhances the efficiency and reliability of manufacturing, even at commercial scales, and reduces potential delays.
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Fast Track
Stage 1: Knowledge Transfer and Gap Assessment
Stage 2: Assay Transfer (if applicable)
Stage 3: Fast Track Manufacturing and Fill Finish
When the process is more robust and when no changes are required
Stage 4: Quality Control (QC) Testing and Batch Release
Stage 5: Regulatory Support
Stage 6: Stability Studies -
Modular
Stage 1: Knowledge Transfer and Gap Assessment
Stage 2: Assay Transfer (if applicable)
Stage 3: Modular Track Fully Customizable – select the module(s) to suit your program and allow our team to streamline the transition
When the process is not fully developed or when changes are requiredCell Line > Phase-appropriate Plasmid Supply > Adherent or Suspension Pilot/Process Development (PD) Run > Comparability/Bridging Studies > Assay/Analytical Development (AD)
Stage 4: Engineering/GMP Runs and Fill Finish
Stage 5: Quality Control (QC) Testing and Batch Release
Stage 6: Regulatory Support
Stage 7: Stability Studies
Explore our Viral Vector CDMO Facility
Specializing in GMP-compliant production of adeno-associated virus (AAV), lentivirus, adenovirus, and retrovirus for gene and gene-modified cell therapies.
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Your Reliable Viral Vector Technology Transfer Partner for Project Continuity
- Expertise and flexibility: Offering stability in times of change, with established processes, in-house analytics with premium assay development capabilities, and robust production platforms, our specialized team has been at the forefront of the CGT industry for decades.
- “Plug and Play” solutions: Our methodical tech transfer framework lets you choose the technology you want to transfer (and when) to minimize the need for bridging & comparability studies. Whether you're in Phase 1, 2, pivotal, or ready for commercial manufacturing, we can seamlessly adapt to your needs with a Modular or Fast Track approach in as little as nine months.
- Unmatched experience: Charles River has a track record of over 75 years supporting the development of therapeutics, including 20 FDA-approved cell and gene therapies to date along with decades of plasmid, viral vector, and cell therapy CDMO experience.
- Dedicated facility: Our viral vector center of excellence, located in Maryland, US, offers viral vector tech transfer and manufacturing to support any stage of the drug development lifecycle, from research-grade viral vector manufacturing for in vitro and in vivo studies through to commercial scale GMP manufacturing.
- Integrated capabilities: With full-scale, in-house production capabilities, our viral vector facility is fully equipped to handle viral vector technology transfers for a wide range of viral vectors, including custom designs as well as commonly used types like AAV, adenovirus, lentivirus, and retrovirus. Our integrated concept to cure portfolio spans discovery through safety assessment and on to commercialization.
Safeguard Your Tech Transfer Program
Explore key challenges and critical considerations for smooth viral vector tech transfer, drawn from over 20 years of expertise in gene therapy development and manufacturing.
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Specialized Viral Vector Production Platforms
Leverage established viral vector manufacturing platforms capable of cutting a viral vector gene or gene-modified cell therapy program’s timeline to GMP by up to 55% versus traditional manufacturing processes. Eliminating the need for substantial process development, our nAAVigation® (AAV) and Lentivation™ (LVV) platforms are standardized and scalable, encompassing upstream production, downstream processing, and analytics to accelerate your gene therapy program.
- Speed
- Predictability
- Track record
Transferring your viral vector to Charles River gives you access to these specialized production platforms to safeguard, standardize, and help maximize resource efficiency.