Small Molecules: From Process
Development to Commercial
Development to Commercial
Dedication to continuous improvement and ongoing capabilities expansion has made us a valuable long-term partner to our clients.
For more than fifty years, BIOVECTRA has assisted clients with small molecule projects from investigational new drug (IND) applications through clinical trials and commercial supply, providing phase-appropriate solutions. We focus on delivering clinical trial scale product quantities while addressing scale-up requirements and long-term manufacturing options that address key cost of goods (COGs) targets.
Our experience in a wide variety of complex chemistries provides diverse route options and is another key reason clients rely on us. Specifically, our ability to develop and manufacture APIs through both synthetic routes and fermentation, sometimes combining the two approaches, allows our clients to leverage the best of both worlds.
A passionate commitment to helping our clients make the best decisions, solve problems, and keep their projects on track is at the forefront of all we do.
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.
Fortified Supply Assurance
Supply Chain Continuity for Essential Products
We have been manufacturing products essential to the pharmaceutical industry for over fifty years, relying on a procurement team managing complex inventories and creating robust supply chains, even in the most challenging times. This includes highest purity grade DTT, and more.
Improved Process Economics
Optimizing Transfer from Lab to Manufacturing Floor
Our process transfer team tightly integrates the process development team’s work with manufacturing realities. The cohesiveness and experience of the BIOVECTRA team address problems and process optimization opportunities quickly and effectively.
Robust Process Infrastructure
The wide range of currently available process infrastructure minimizes required new construction or build-out offering the potential for capital efficiencies and substantial cost savings.
Programs Aligned to Client Timelines
Synthetic small molecules clients often come to BIOVECTRA with extremely tight project timelines. By having complementary expertise within our organization—method development, process analytics, process development, and the full range of production scales—we rise to the challenge.
Early Phase Product Production
While we begin process development with commercial production in mind, sometimes clients need to move quickly to produce Phase I and Phase II material knowing that detailed product and process characterization, as well as efficiency optimization, will need to come later.
Highly Skilled, Reliable Partner
Batch and Flow Chemistry Expertise
BIOVECTRA began developing continuous processes in the mid-’90s. We constantly perfect flow chemistry GMP capabilities to offer both continuous processing and batch processing at commercial scale.
Managing Controlled Substances and Highly Potent API
We are skilled at managing FDA-grade controlled substances and associated regulatory requirements and working with highly potent API.
Scope and Scale
- 100 – 19,000L reactors
- Commercial-scale purification technologies
- Automated, vacuum belt filtration
- Semi-continuous centrifugation
- Large-scale drying
- Annual throughput >200MT
- Batch & continuous solvent recovery systems
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.
Browse Other Areas of Expertise
High Potency APIs
Ready to learn how BIOVECTRA can help?
Contact us today!
Contact us today!