What type of contract manufacturing solutions does API provide?

From preclinical to commercial manufacturing, our facilities and technical capabilities support the entire drug development lifecycle. We are equipped to handle complex projects including small molecule active pharmaceutical ingredients and sterile injectables, ensuring reliability, safety, and compliance at every step. 

K&R 24 769

Formulations 

K&R 24 725

Contract Manufacturing Services

Clinical Trial Manufacturing

Our clinical trial material manufacturing capabilities are designed for precision and flexibility. 

  • Product Type: Active drug products delivered as capsules, tablets, gels, creams, or injectables.  
  • Placebo Manufacturing: Placebo dosage form design and manufacturing to match your active drug product, for placebo controlled clinical trials. 
  • Stability Testing: Quality controlled stability studies to determine the shelf life of your active drug products and placebos. 
  • Packaging and Labeling: Clinical trial ready capsules, tablets, tubes, and blister packs (active and placebo). 
  • Controlled Substance Manufacturing: Specialized handling of potent APIs and controlled substances. 
  • Health Canada Licensing: Commercial Drug Establishment License, Natural Health Product Site License, and Controlled Substances License. 

Prototype Production 

Our facilities at the University of Alberta and Life Sciences Campus at Edmonton Research Park bridge the gap between R&D and commercial production. 

  • API Synthesis: Up to 20L batch size of active pharmaceutical ingredient synthesis, supporting early clinical phases. 
  • NHP Manufacturing: Development and GMP production of NHPs and OTC products. 
  • Liquid Formulations: Expertise in solutions and suspensions. 
  • QC Testing Labs​: Testing of raw materials, APIs, and finished dosage forms (injectables, solutions, suspensions). 

Commercial-Scale Manufacturing  

Our 83,000 sq. ft. GMP manufacturing facility within the Life Sciences Campus at Edmonton Research Park is designed to deliver sterile products, including injectables, for commercial markets, with capabilities for both small and large batch manufacturing.

  • Aseptic Manufacturing: High-throughput production of sterile finished products with automated robotic filling lines. 
  • Product Types: Sterile injectables in vials (1–20 mL) or bottles (20–100 mL), solutions, powders, and emulsions. 
  • Annual Capacity: Up to 73.2 million doses per annum, and a sprint capacity that can meet the demands of the entire Canadian population for a critical product within 100 days.  
  • Advanced Testing and Quality Control: Micro laboratory support for sterile testing, environmental monitoring, and GMP compliance. 

Warehouse and Distribution 

  • Secure storage of raw materials, APIs, and finished products.  
  • Streamlined import/export logistics to support global distribution.  

With the added expertise of our Early Discovery & Development, Regulatory & Quality, and Quantitative Solutions (QS) teams, we offer seamless integration across the innovation pipeline—from discovery and clinical strategy to manufacturing. Our comprehensive approach ensures a streamlined pathway for innovators, delivering tailored solutions for every stage of development to market. 

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Meet Our Contract Manufacturing Solutions Team

Allan Aginski
Member Highlight Hans Bauer
Vijay Somayaji
Trepanier, Daniel

Ready to take your life sciences innovation to the next level?

Contact us today for a free 1-hour discovery consultation to determine how we can bring your idea to market together.