mRNA, pDNA, and LNP Products
We’re applying our lipid and fermentation experience and end-to-end biomanufacturing capabilities to a new set of modalities: mRNA, pDNA, and lipid nanoparticle (LNP) products.
Nucleic acid-based therapeutics have only begun to demonstrate their vast potential for improving human health. However, these biologic products have a complex manufacturing process with unique needs at multiple steps. This complexity often leaves drug developers coordinating between three or more vendors to cobble together their bioprocesses.
As a fully integrated CDMO, BIOVECTRA can help you overcome challenges with current programs and maximize efficiency and quality for your mRNA, pDNA, or LNP product. Dive into our capabilities below, then contact our experts for further details.
Explore Our State-of-the-Art Facilities
Comprehensive Services Across Locations
Across our 5 cGMP facilities, we offer manufacturing at scales ranging from preclinical to commercial. Our state-of-the-art process development and analytical testing laboratories cover everything from cell line development to GMP production and fill finished products.
New Dedicated Biomanufacturing Center
Our Charlottetown mRNA biomanufacturing center, which opens in 2023, will boast:
- 36,000 square feet of new, state of the art manufacturing space
- cGMP-compliant facilities
- Manufacturing capabilities for nucleic acids (mRNA and pDNA)
- LNPs formulation capability
- Vaccine and therapeutic production capacity for 160 million doses per year
- Fill/finish capacity for 70 million doses per year for commercial distribution
- 125 highly skilled staff members dedicated to nucleic acid product manufacturing
Take Your Nucleic Acid Product All the Way
Benefit from End-to-End Efficiencies
BIOVECTRA has the staff, facilities, technology, and expertise to take your nucleic acid product from development all the way to commercial manufacturing. Working with us at every stage eliminates the need to coordinate between multiple vendors and gives you fortified supply chain continuity. Together, these benefits have the potential to lower costs and reduce risk of supply disruption, miscommunication, or failed process transfers.
Work with a Dedicated Team
Working with BIOVECTRA experts, from start to finish, also gives you access to insights and tips from a team that intimately knows your mRNA, pDNA, or LNP product. This familiarity, combined with our rigorous compliance processes and thorough documentation, can help optimize regulatory submissions and streamline the progression to commercial manufacturing.
Proven Expertise for New Applications
Over 50 Years of Experience
BIOVECTRA has over five decades of extensive experience in fermentation, small molecule production, and quality management for regulatory compliance. We have a strong record of successful inspections (including Health Canada, FDA and PMDA), and have supported clients from clinical to commercial scale on projects ranging from raw materials (bioreagents), APIs, to drug substances including high potency production.
This breadth of knowledge allows us to move quickly from idea to implementation when creating nucleic acid drug products. We are also able to generate source or synthesize all components of LNPs, including pegylated lipids, ionizable lipids, and phospholipids.
Work with an Expert Team
We’ve hired experts in nucleic acid product manufacturing to augment our existing team’s expertise. These scientists and technicians bring a deep understanding of the unique challenges and requirements based on their extensive experience developing and manufacturing these products successfully.
Partner with Us to Customize Your Process
Optimize Your Product Your Way
With our broad expertise and advanced manufacturing options, we offer versatility to fit every preference. If you’ve developed your own mRNA, pDNA, or LNP processes before partnering with us, we enable full technology transfer for seamless continuation of your development and manufacturing journey. However, we also offer platform production processes and technology that can provide reliability and simplification for your nucleic acid vaccines and therapeutics.
Demonstrated experience in process development and characterization, offering phase appropriate solutions and rapid optimization.
Targeted analytical support from early development to validation of commercial processes and continuous process verification, all along the life cycle of your program.
Dedicated tech transfer teams ensuring a seamless transition from development to manufacturing - collaborating with our clients with a problem-solving mindset.
Supplying our clients with pre-clinical and clinical material to enabling them to move quickly and cost-efficiently through the clinical phases.
De-risking our client’s programs by effectively managing the transition from lab to pilot to manufacturing scale.
A proven history of commercial manufacturing partnerships growing alongside our clients. Effective collaboration increasing speed-to-market.