Small Molecules: From Process Development to Commercial API Manufacturing

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.

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“I’m energized by how we are strengthening our continuous processing capabilities. For example, avoiding the need to store hazardous intermediates will offer a lot of value to our clients. Also, enhancing these capabilities facilitates more cost-efficient production of high-volume, ongoing manufacturing.”

—Richard Bethell, Director, Manufacturing Operations

“Clients often come to us with projects that have tight timelines. The high level of integration across our teams, highly experienced team members, and our commitment to success allows BIOVECTRA to meet our clients’ challenging requirements.”


—John Riley, Director, Complex Chemistry Process Development

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.

Accelerated Speed-to-Market

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

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.

Browse Other Areas of Expertise

mRNA/pDNA

High Potency APIs

Project Support

Bioreagents

Biologics

Ready to learn how BIOVECTRA can help? Contact us today!

SEO plus – Test

  • 20+ years at GSK, leading R&D activities on multiple vaccine programs
  • Recently held positions in industry include: Senior Director (Function Head), Protein Biochemistry; Director, Antigen Design & Prototype Production; and, Associate Director, Antigen Design and Protein Characterization.
  • Key areas of expertise are:
    • Process development of protein Biologics/Recombinant Antigens
    • Recombinant protein expression (mammalian, insect, yeast, bacterial)
    • Production/design of Viral Vectors, mRNA vaccines, Bacterial outer membrane vesicles
    • Protein Engineering and Structural Biology
    • Defining quality attributes, biophysical characterization of proteins, and analytical strategy
  • Post graduate degrees in Functional Genomics (Université Laval) and Bioinformatics (MIT); M. Sc. Microbiology and Immunology (Laval).
  • 25+ Patent & 5 Scientific Publications

Normand Blais – Senior Director Development & Innovation, Biologics

  • 20+ years at GSK, leading R&D activities on multiple vaccine programs
  • Recently held positions in industry include: Senior Director (Function Head), Protein Biochemistry; Director, Antigen Design & Prototype Production; and, Associate Director, Antigen Design and Protein Characterization.
  • Key areas of expertise are:
    • Process development of protein Biologics/Recombinant Antigens
    • Recombinant protein expression (mammalian, insect, yeast, bacterial)
    • Production/design of Viral Vectors, mRNA vaccines, Bacterial outer membrane vesicles
    • Protein Engineering and Structural Biology
    • Defining quality attributes, biophysical characterization of proteins, and analytical strategy
  • Post graduate degrees in Functional Genomics (Université Laval) and Bioinformatics (MIT); M. Sc. Microbiology and Immunology (Laval).
  • 25+ Patent & 5 Scientific Publications

Oliver Technow - Chief Executive Officer

  • Industry Master Degree from Frankfurt Chamber of Commerce, Frankfurt Germany.
  • More than 20 years of global pharmaceutical industry experience.
  • Held numerous leadership positions in commercial development, marketing and brand management, and lifecycle management and has extensive product launch and market access expertise in Europe and North America.
  • In 1997, joined Eisai GmbH in Frankfurt, Germany and in 2002, was appointed Director, CNS Business Unit; in 2006, was appointed Vice President, Head of Global Marketing for Eisai Inc. in Woodcliff Lake, NJ;  in 2011, was appointed Vice President, Established Products Business Unit; in 2013, was appointed President & General Manager for Eisai Limited in Mississauga, ON.
  • Appointed President of BIOVECTRA Inc., December 10, 2015.
  • Board Director for BIOTECanada
  • Member of the Steering Council of Innovative Medicines Canada (IMC)
  • In 2017, appointed to the Government of Canada’s Health/Bio-sciences Strategic Economic Table
  • In November 2019, promoted to Chief Executive Officer at BIOVECTRA
  • In June 2020, named new Chair of PEI BioAlliance Board of Directors