Our Sterile Injectables Manufacturing Services
From small-scale clinical batches to large-scale commercial production, our cGMP-compliant facilities are equipped to handle the full spectrum of sterile injectables needs. Whether it’s vials, bottles or custom formulations, we provide robust, scalable and globally competitive solutions for the drug development lifecycle.
Services Overview
cGMP Production
Full compliance with current Good Manufacturing Practices (cGMP) for sterile injectables at every stage of manufacturing.
Aseptic & Terminal Sterilization-Based Manufacturing
Fully automated, robotic filling lines in isolators with low reject rates & line losses.
Product Types
Injectables in vials (1–20 mL) and bottles (20, 50, 100 mL).
Formulation Development
Liquids, emulsions, liposomes solutions, powders, and suspensions.
Large & Small Molecules
Including peptides, oligonucleotides, and non-contaminating biologics.
Packaging Solutions
A variety of primary packaging options tailored to your product needs.
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Get In TouchContract Development Manufacturing Services & Facilities
Clinical Trial Manufacturing
We offer flexible, precise clinical trial manufacturing for sterile injectables, bridging the gap between R&D and commercial production. Our GMP-compliant facilities—including the Katz Group Centre for Pharmacy and Health Research, the Biotechnology Business Development Centre (BBDC), and the Critical Medicines Production Centre (CMPC)—are designed to support early-stage formulation, testing, and production.
Key Facility Features Supporting Clinical Manufacturing
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Biotechnology Business Development Centre (BBDC)
- GMP chemical lab specializing in sterile liquid formulations (injectables, emulsions, suspensions)
- Small molecule chemical synthesis up to 20L
- HPLC, UPLC, GC-MS, TOC, particle sizing, and stability chambers
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Drug Development & Innovation Centre (Katz)
- Sterile injectables prototyping and small-scale batch production (up to 10 kg)
- Packaging & labeling: up to 10,000 units/day in vials, bottles, or blister packs
- Product stability testing for shelf-life studies
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CMPC (Clinical side)
- Sterile formulation rooms, IPC production, and cleanroom gowning areas
- Terminal sterilization and in-house microbiology labs for sterility and bioburden testing
Contract Development Manufacturing Services & Facilities
Commercial-Scale Manufacturing
The Critical Medicines Production Centre (CMPC)—our 83,000 sq. ft. GMP facility in Edmonton—is purpose-built for large-scale sterile injectable manufacturing. With advanced aseptic processing, robotic filling and terminal sterilization capabilities, we ensure seamless scale-up from clinical to commercial supply.
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CMPC Highlights (Commercial)
- Automated aseptic filling lines in isolators
- Terminal sterilization with rotating autoclaves
- Packaging and automatic visual inspection lines
- Onsite microbiology labs for GMP sterility testing
Why Sterile Injectables Require Specialized Expertise
Sterile injectables are among the most complex pharmaceutical products to manufacture—for good reason:
- Injectables bypass the body’s natural defenses, so ensuring your product is sterile and completely free of viable microorganisms is vital.
- Aseptic manufacturing controls every stage of production—from raw material storage and formulation to final filling and packaging—to eliminate contamination risk.
- You need a process partner who supports the full journey—from determining production requirements to packaging and regulatory strategy.
With advanced facilities, strategic and technical expertise, and industry experience, our team is equipped to seamlessly guide your product through production—no matter how complex.
Meet Our Senior Leaders and Contacts
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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