We Care About the Processing and Handling of High Potency API

Dedicated to solving complex problems and managing increasingly demanding products—we’re committed to high potency API excellence

As the pharmaceutical industry improves highly potent therapeutic targeting using small and large molecule approaches, the demand for high-potency API (HPAPI) continues to increase. With extensive HPAPI process development and production experience for small and large molecule APIs, BIOVECTRA is here to advance your project. Complex products that require specific handling, conjugation, or other specialized processing are areas where BIOVECTRA shines.

We offer pilot-to-commercial-scale HPAPI capabilities, providing full support throughout the product life cycle.

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“‘We strive to achieve the slightly impossible.’ Many things can impair HPAPI fermentation, and once you lose time, it is challenging to recover. When problems do arise, our teams take tremendous pride in putting the effort back on track.”

– David Ball, Manufacturing Manager

“I’ve found it so important to have a defined project team. Specialists across the project meet regularly to review the other teams’ work and understand the larger project picture. This collaboration helps us to design much better processes, improve product quality, enhance efficiency, and strengthen the cohesiveness of the entire effort.”

– Scott Greer, Manager, Technical Operations

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Deeply Committed to Proper HPAPI Handling
Knowing just how high the stakes are and the liability our clients face, we take HPAPI very seriously. Ongoing and thorough team training, the proper personal protective equipment (PPE), advanced containment expertise, and other critical elements of successful HPAPI production are available for your HPAPI program’s deployment.

Extensive HPAPI Experience
Our first commercial-scale HPAPI process was validated nearly twenty years ago. Since then, we have continually strengthened our capabilities managing increasingly challenging products. BIOVECTRA exceeds Environmental Health & Safety (EHS) compliance standards through comprehensive, highly potent material handling training and extensive environmental monitoring using industrial hygiene methods.

Improved Process Economics

Application of Process Automation Technologies Aid Containment
Process automation technologies (PAT) are used across BIOVECTRA’s operation but are especially critical for high potency API production. Continuous monitoring reduces manual sampling protecting both products and workers, as well as creating greater efficiencies.

Processing Scales for the Full Product Life Cycle
We offer production scales for a product’s entire life cycle—clinical, pilot, small-batch, and commercial production—within one organization, facilitating seamless product progression from clinical development to commercialization and efficient handoffs.

Accelerated Speed-to-Market

Strong Relationships with Regulators
BIOVECTRA has strong relationships with North American regulatory bodies (FDA, Health Canada) enabling expedited New Substance Notifications, ensuring timely scale-up and commercial production. Additionally, BIOVECTRA’s clients benefit from Health Canada’s mutual recognition agreements with the UK’s Medicines and Healthcare products Regulatory Agency, European Medicines Agency, and Australia’s Therapeutic Goods Administration.

Highly Skilled, Reliable Partner

Specialized HPAPI Formulation Capabilities
Our team is highly experienced with a diverse range of HPAPI drugs, including nanoparticle and depot formulations. 

Development of New Safety Protocols
Many HPAPI manufacturing processes involve new chemical entities (NCE) or new biologic entities (NBE). BIOVECTRA has experience developing safety protocols for both NCEs and NBEs. Combining our EHS and technical process development expertise, we establish paths to handle new products with limited information. Doing so generates missing data for our clients, allowing clinical development to progress.

Scope and Scale

  • Occupational Exposure Limits (OEL)—20 ng/m³ (SafeBridge Band 3 & 4)
  • Up to 100L glass reactors
  • 2 kg batch size, 40 kg annual output
  • Last 5 years, 100% right first time

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.

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