Closed-process containment, optimized processes, accelerated speed-to-market —our team is passionate about exceeding clients’ expectations
Route options are valuable when approaching API production, and BIOVECTRA offers robust microbial fermentation and chemical synthesis capabilities. Many of our programs utilize microbial fermentation to complete designated transformation steps, and the product is then seamlessly handed off to our synthetic small molecule team for further processing.
We provide commercial microbial fermentation capabilities, offering full support throughout products’ life cycles. Clients come to us with complex problems that require flexibility and creative solutions. Our experience and dedication give them the confidence that we can execute their programs successfully.
Fortified Supply Assurance
Extensive Microbial Fermentation for API Experience
The supply of our clients’ products is in good hands given BIOVECTRA’s more than 20 years of experience producing commercial quantities of API using long microbial fermentation processes within an established GMP environment.
Contamination Mitigation Expertise
Many of our clients are concerned about the risk of contamination, particularly for longer fermentation processes. By utilizing technologies initially designed for sterile API production, BIOVECTRA has engineered the ability to safely mitigate contamination risks.
Improved Process Economics
Optimizing Fermentation Processes
We increase yields by analyzing, understanding, and optimizing fermentation and purification processes to not only achieve clients’ targets but frequently go well beyond them.
Exquisite Execution Over Extended Production Campaigns
Our clients rely on us for consistent execution—delivering their products properly every time.
Accelerated Speed-to-Market
Parallel Development
To maximize speed to product release, our bioanalytical group is structured to ensure that method qualification and validation activities occur in parallel to scale-up and engineering activities.
Comprehensive Capabilities Aligned Under One Roof
To provide clients maximum speed-to-market, product quality, and flexibility, BIOVECTRA offers a full suite of capabilities within one organization, including robust process analytical expertise, process development, and commercial manufacturing.
Highly Skilled, Reliable Partner
Highly Efficient, Customized Downstream Processing
Downstream processing can be quite challenging as products have ranging characteristics and sensitivities. It’s all too easy to create filtration bottlenecks that cause safety issues and very long cycle times, increasing cost of goods. BIOVECTRA uses approaches tailored to each process’s challenges, with product quality, efficiency, and client needs at the forefront.
Experience with a Wide Range of Hosts
To offer maximum flexibility and capability, BIOVECTRA deploys decades of fermentation and purification experience with a wide range of hosts, including fungi, yeasts, as well as anaerobic and gram-negative bacteria.
Industry-Leading Instrumentation
Our facility houses two VanRx instruments that can be run in parallel for faster turnaround times. Benefits of these instruments include:
- Gloveless isolator technology that eliminates the need for manual intervention
- Single-use technology for all product contact parts to reduce the risk of contamination
- Method-based recipe programming of internal robotic controls that ensures reproducibility and consistent vial dosing across the batch
- Separate material transfer isolator and filling isolator that allows for seamless batch production (up to 20,000 vials/day per filler)
- Statistical weight check with 100% verification of filled vials at run end to ensure reproducibility and minimal product line loss
- Environmental monitoring compliant with Annex 1 that uses volumetric air sampling, avoiding challenges associated with settle plates
- Accurate fill process: from 0.2 –2 mLs instrument has 1.5% accuracy; above 2 mLs it has 0.5% accuracy
- Inert gas overlay capabilities
- Light-sensitive fills are available. Please inquire if you have a light-sensitive product.
- Prefilled syringe manufacturing capabilities that use press-fit closures to control bubble size
Scope and Scale
- Commercial Scale Fermenters
- Flasks
- 2 x 30 L
- 1000 L
- 10,000 L
- 15,000 L
- 56 L potent chromatography column with UV driven fraction collection system
- Experienced with fungi, yeasts, anaerobic and gram-negative bacteria
Process Development
Demonstrated experience in process development and characterization, offering phase appropriate solutions and rapid optimization.
Analytical Development
Targeted analytical support from early development to validation of commercial processes and continuous process verification, all along the life cycle of your program.
Tech Transfer
Dedicated tech transfer teams ensuring a seamless transition from development to manufacturing - collaborating with our clients with a problem-solving mindset.
Clinical Development
Supplying our clients with pre-clinical and clinical material to enabling them to move quickly and cost-efficiently through the clinical phases.
Scale-Up
De-risking our client’s programs by effectively managing the transition from lab to pilot to manufacturing scale.
Commercial Scale
A proven history of commercial manufacturing partnerships growing alongside our clients. Effective collaboration increasing speed-to-market.
