Our Small Molecule Manufacturing Services
Whether your product is a small molecule or a natural health product, our facilities offer a full suite of cGMP-compliant services tailored to your formulation and development specifications. We specialize in formulation prototyping, batch production for clinical trials, and comprehensive analytical support.
Services Overview
Formulation Development & Prototyping
Flexible production capabilities for chemicals and active pharmaceutical ingredients (APIs).
Throughput & Scale
Small-scale chemical synthesis up to 20L, ideal for early development, scale-up studies and custom commercial applications.
Pre-Clinical & Clinical Manufacturing
Integrated manufacturing support from clinical phases to full GMP commercial production.
cGMP Production
In-house GMP Quality Control (QC) labs supporting rigorous testing of small molecules to ensure product quality, safety and regulatory readiness.
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Get In TouchContract Development Manufacturing Services & Facilities
Clinical Trial Manufacturing
We offer adaptable, high-quality clinical trial manufacturing for small molecule therapeutics, supporting seamless transition from preclinical research through late-stage development. Our GMP-certified facilities—the Drug Development and Innovation Centre on the Katz Group Centre at the University of Alberta and the Biotechnology Business Development Centre (BBDC)—are purpose-built to enable efficient small-batch production, process optimization, quality control testing and stability studies, helping accelerate the path from discovery to clinical application.
Key Facility Features Supporting Clinical Manufacturing
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Biotechnology Business Development Centre (BBDC)
- Small molecule chemical synthesis up to 20L
- R&D manufacturing: Clinical phase to commercial-scale GMP Production
- Additional R&D lab space for process development and optimization
QC analytical lab specialized for chemicals, APIs and finished products
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Drug Development & Innovation Centre (Katz Group Centre)
- Small-scale small molecule production (up to 10 kg batches)
- Small Molecule API production for clinical phase I and II
- Full-service QC analytical lab certified with Drug Establishment License
- Small-scale small molecule production (up to 10 kg batches)
Contract Development Manufacturing Services & Facilities
Commercial-Scale Manufacturing
The Critical Medicines Production Centre (CMPC)—our 83,000 sq. ft. GMP facility—is purpose-built for large-scale commercial manufacturing of finished products with small molecule active pharmaceutical ingredients (APIs).
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CMPC Highlights (Commercial)
- Automated state-of-the-art aseptic filling lines in isolators
- Terminal Sterilization with Washer/Sterilizer
- Packaging and automatic visual inspection lines
- Onsite microbiology labs for GMP sterility testing
Why Small Molecule Production Require Specialized Expertise
Small molecules are among the most essential pharmaceutical products to manufacture—for good reason:
- Precision is critical: Small molecule production involves complex, multi-step chemical synthesis, requiring precise control to ensure consistency, purity and efficacy. Impurities, even in trace amounts, can affect safety and efficacy, making robust process development and stringent quality control essential to successful manufacturing
- Quality, expertise, and compliance go hand in hand: Manufacturing these compounds demands specialized expertise—from raw material handling and reaction optimization to purification, formulation, and analytical testing—all within strict GMP compliance.
- You need a process partner who can guide the full journey—from early development and scale-up to regulatory support and commercial production.
Meet Our Team
Allan Aginski
Senior VP, Special Projects & Manufacturing
Read bioabout Allan Aginski Allan Aginski
Senior VP, Special Projects & Manufacturing
Allan is a life sciences supply chain and manufacturing specialist with nearly 40 years of experience. He has established and run commercial life sciences company production facilities around the world, including for companies such as Abbott, Merck, and Genpharm. He has been responsible for the establishment of dozens of products in over 24 countries.
Hans Bauer
VP, Technical Operations
Read bioabout Hans Bauer Hans Bauer
VP, Technical Operations
Hans brings over 25 years of experience in pharmaceutical manufacturing and quality, having worked with leading pharmaceutical companies in Europe, including Lonza, Sandoz (Novartis), Acino, and Akorn. He has a proven track record in managing large teams, complex projects, and overseeing comprehensive operations.
Hans has strong expertise in developing and implementing robust quality systems that meet stringent regulatory standards across several countries, including the US, EU, and Switzerland. His production expertise includes API-small molecule manufacturing, peptide chemical and biotechnology manufacturing, as well as the production of solid and semi-solid forms and sterile manufacturing.
Shawn Couch
Director, Business Development
Read bioabout Shawn Couch Shawn Couch
Director, Business Development
Shawn Couch is a seasoned business development and key account management professional with over 20 years of experience in the North American pharmaceutical industry. With a strong track record of surpassing sales targets, he has expertise in drug substance and drug products, including solid oral, and injectables. His career includes business development roles at Corden Pharma, Fabricca Italiana Sintetici and ACIC Fine Chemicals, where he played a pivotal role in expanding market presence and increasing revenue.
Vijay Somayaji
Sr. Director, Product Development & Quality
Read bioabout Vijay Somayaji Vijay Somayaji
Sr. Director, Product Development & Quality
Vijay has over 30 years experience in biotech research and development and QA/QC. With a PhD in Chemistry and post-doctoral work under Nobel Laureate Dr. H. C. Brown, Vijay has served in director level roles at Biomira, AltaRex, Novolytic, and Virexx. As an experienced QA, Vijay has supported product development for dozens of clinical programs taking place at sites around the world.
End-to-End Manufacturing Support
We provide comprehensive manufacturing solutions from preclinical stages to large-scale commercial production. Our integrated approach, combined with our Early Discovery & Development, Regulatory and Quantitative Solutions (QS) teams, ensures a seamless experience at every step of the development journey.
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