gmp viral vector manufacturing
Accelerate your clinical trials
Are you in need of clinical grade viral vectors ?
Our GMP viral vector manufacturing service enables small, medium and large-scale production of high-quality vectors available with the same attribute specifications. At Flash BioSolutions, we offer unrivalled support throughout your journey to the clinic, providing the expertise, reliability and state-of-the-art technology to meet your needs.
End-to-end service
The complete package you’ll benefit from :
- Construct + Plasmid design and Plasmid supply
- Viral vector Manufacturing from R&D to GMP
- Full GMP QCs and Stability studies
- Regulatory support, CMC section
- Project Management
Track record of 20 years
in lentiviral manufacturing
High potency & high purity
compliant with EU & US regulatory standards
Reproducibility of batches
proven throughout scale-up
Seamless Continuum From Discovery To Therapy
Experience a tailored continuum that aligns with the various phases of your clinical trial and regulatory requirements. Through our well-established plug & play production and purification process, we maintain consistent high-quality viral vectors from R&D to GMP grades, guaranteeing the success of your clinical study.
Proof-of-concept
Production of various batches dedicated to viral vector yield optimizations, product characterization, cell transduction assays and specification development.
GMP Phases
Production of viral vector batches in GMP environment for clinical trials with release to the QC specification, and stability studies to support regulatory submissions.
Flash track: fast & tailored viral vectors manufacturing
Interested in accelerating your timeline ?
Discover the time-saving Flash Track option, designed to accelerate your entry into clinical trials while taking advantage of all our capabilities and services.
Our GMP viral vector manufacturing service will be tailor-made to meet your timelines and specifications. Design your project by making an appointment with our GMP experts & Project Managers.
GMP Viral vector quality control (qc)
The reliability and safety of each GMP viral vector batch is defined by a quality control plan and specifications designed for your product release. The state-of-the-art analytical methods used are accepted by regulatory agencies, including the FDA and EMA.
Meeting on Outlook
Regulatory support
We provide support to all customers and partners to prepare the CMC sections of their regulatory submissions as well as to respond to any CMC questions received during Health Authority review. We support you with clinical and commercial submissions, including IND/IMPD applications, BLA, NDA and MAA filings.
PROJECT MANAGEMENT
With Flash BioSolutions, you’ll benefit from regular meetings to discuss the progress of your project, review the results achieved and plan the next steps together, ensuring a smooth and efficient collaboration. We value transparency and trust, keeping you informed at every key stage with detailed reports and clear forecasts.
Our personalized approach guarantees you constant attention and unrivalled support. A dedicated team of experienced project managers will be on hand to answer your questions and tailor strategies to your needs. You can rely on our expertise to quickly identify and resolve any potential obstacles, minimizing delays and costs.
By choosing Flash BioSolutions, you accelerate the development of your breakthrough therapy, from the development phase through to the clinic and market launch. We are committed to turning your innovative ideas into effective treatments that improve patients’ lives. Your project is our top priority, and we are committed to bringing it to fruition with the highest levels of quality and efficiency.
FAQ
What are the production times for GMP viral vectors?
Your needs, your deadlines! If your construct fits directly into our platform processes, then we can supply your GMP batch within 6 months. If your project requires several adjustments and special requests, the lead time can be longer, up to 12 months.
How is the quality and safety of viral vectors guaranteed?
With two decades of expertise, Flash BioSolutions has perfected a robust production and purification process, consistently delivering top-tier vector quality. What sets us apart? Our analyses, which form an integral part of our quality control plan, enable the production of batches that are strictly cGMP compliant and meet the requirements of regulatory agencies.
How does Regulatory Support work and what are the crucial steps in GMP production?
Our Project Manager and Quality Director will guide you through the FDA/EMA requirements and offer regulatory advice on test selection for GMP QC and stability studies. You’ll receive all the documentation you need to gain approval/authorization and take your next breakthrough therapy through to the first clinical trial, and beyond.
CONTACT US
Fill in the form below and our team will contact you shortly to explore how we can help you turn your ideas into success.
+33(0) 5 61 28 70 75
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Discover our leading industrial capabilities
Want to find out more about how we deliver your projects with precision and reliability? Visit our dedicated laboratories and production capabilities page to discover our robust infrastructure and industrial expertise.