As part of the Canadian Critical Drug Initiative (CCDI), our team at Applied Pharmaceutical Innovation (API) is building the Critical Medicines Production Centre (CMPC). The CMPC will produce sterile or aseptic fill and finish of traditional small molecule and non-contaminating biologic drugs at a capacity required to address drug shortages and respond to critical supply needs during a crisis. This facility is a major advancement – building capacity for domestic pharmaceutical manufacturing and supply chain resiliency.
Available through API’s integrated CDMO services, the CMPC provides life sciences
innovators with reliable end-to-end drug development support right here in Canada, helping address challenges related to tech transfer, scalability, process consistency and pharmaceutical manufacturing efficiency.
Supporting the Full Drug Development Lifecycle
On the outside, the Critical Medicines Production Centre (CMPC) looks like a typical large-scale manufacturing facility. Inside its 83,000+ square feet, however, is one of the most advanced Annex 1 compliant sterile pharmaceutical manufacturing environments in Canada, designed to accelerate commercialization timelines and help de-risk the drug development process.
Built to strengthen Canada’s drug supply chain, the CMPC, together with API’s adjacent
72,000 square foot Biotech Business Development Centre (BBDC) and additional offsite labs, combines advanced automation, integrated production systems to support efficient, scalable pharmaceutical manufacturing, from clinical trial material (CTM) manufacturing through to commercial production.
Beyond manufacturing, API supports chemical process development, analytical methods
and formulation; enabling a seamless transition from early-stage research to clinical and commercial production. By integrating CRO and CDMO services, API delivers reliable, scalable, end-to-end support for innovators.
True End-to-End Drug Development Support
End-to-end support plays a critical role in de-risking drug development. Reducing handoffs between partners allows for faster process transfers, while API’s expertise helps mitigate risks, address development hurdles and maintain consistency from early-stage research through clinical and commercial manufacturing.
Scaling pharmaceutical manufacturing is one of the more difficult stages of drug development. One of the largest challenges innovators face is transferring products between different production lines as the process moves from clinical manufacturing to commercialization.
Each transfer introduces new layers of complexity that can impact timelines, costs and product consistency. From additional validation requirements to operational variability across equipment and environments, even well-established processes can face delays and inefficiencies when moving between manufacturing settings.
At the CMPC, sterile vial and bottle batch sizes can be as low as 500 units or as high as 250,000 depending on the size. There is no need to transfer from one line to another as production moves from the clinic to commercial.
The CMPC was intentionally designed to mitigate risks, helping reduce regulatory delays and batch failures while accelerating the path to commercialization. In addition, we offer chemical analytical development and microbiological analytical development including analytical method validation supported by dedicated storage capacity,
freezers and cleanroom facilities. For innovators navigating an industry where
only a small percentage of Phase 1 clinicals ultimately commercialize, reducing manufacturing uncertainty is key.
Advanced Manufacturing Technology at CMPC
The CMPC’s infrastructure was designed around advanced pharmaceutical manufacturing technologies that improves flexibility, scalability, quality control and manufacturing efficiency. Working closely with Steriline, Romaco, Fedegari, Antares and Optel, API developed a custom, highly integrated manufacturing environment that is purpose-built for modern sterile pharmaceutical manufacturing.
Advanced Fill-and-Finish System for Clinical and Commercial Manufacturing
The CMPC’s automated sterile fill-and-finish system from Sterline was developed to
efficiently reduce line loss and safely prepare drug products for both clinical and commercial manufacturing.
For drug developers, fill-and-finish is often a critical stage where delays, inefficiencies and manufacturing risks can arise. The CMPC’s integrated system was designed specifically to reduce those risks while supporting a faster, more reliable path to commercialization.
Using advanced robotics automation, the system can fill, handle, stop and cap vials and bottles across a wide range of product volumes (1ml to 100ml) and packaging
configurations (vial sizes 2R to 20R and bottle sizes 20ml to 100ml). This flexibility allows the site to manage a wide range of products and projects without requiring major line
changes or equipment transfers.
What This Means for Drug Developers
- Low primary packaging costs: With a built-in washer and depyrogenization the filling line does not rely on expensive pre-sterilized vials and bottles, dramatically lowering the costs of primary packaging.
- Batch sizes match development needs: The CMPC is well suited to accommodate early-stage clinical manufacturing as well as scaling up to larger, more commercial volumes
without compromising consistency or quality. This is particularly useful for secondary site operations where the facility can rapidly increase throughput.
- Scaling up is de-risked: The engineering team behind the CMPC has ensured the facility and the custom-built equipment can maintain consistency when transitioning from clinical to larger-scale manufacturing. This is accomplished
through controlled fluid dynamics, mechanical handling and robotic automation
across batch sizes.
- One production line means faster transitions and fewer delays: One line reduces
reliance on multiple conveyors, minimizes tooling changes, enables a faster set-up, faster validation and faster turnaround time. One line means optimal efficiency.
- Quality control, built-in: The CMPC has advanced in-process technology that ensures
precise filling and capping with the ability to top up underfills and recap when closures are incomplete, without stopping. This means consistency in the product and extremely low line losses for high value products.
- Can manufacture multiple product types: At the CMPC, we have both liquid and powder filling capabilities. This includes 1, 2, 5, 10 and 20 mL vials, as well as 20, 50 and 100 mL bottles.
A system that can adapt to your manufacturing needs rather than forcing your
manufacturing to adapt to the system significantly reduces delays, simplifies and
de-risks scale-up. Overall, the CMPC fill-and-finish line improves development outcomes dramatically.
Rotary Autoclave Technology
The CMPC also incorporates a specialized rotary autoclave system from Fedegari
designed for emulsion and suspension products.
What This Means for Drug Developers
- Sterile liquid product processing: The CMPC can sterilize complex liquid formulations while maintaining product consistency and stability. For companies producing sensitive injectable products that require precise sterile manufacturing conditions, this is a necessity.
- Vial and bottle sterilization: Integrated sterilization capabilities streamline manufacturing workflows, eliminating the reliance on external sterilization vendors.
This means faster turnaround times and fewer supply chain dependencies.
- Washing and sterilization of filling line components: Proper sterilization of manufacturing components is necessary for maintaining sterile conditions and meeting regulatory standards. Having this integrated into the infrastructure, the CMPC helps reduce downtime between production runs while improving manufacturing efficiency.
The flexibility of this infrastructure helps reduce lead times while supporting reliable, scalable sterile manufacturing operations.
High-Speed Inspection System
Quality control is another defining feature of the CMPC’s infrastructure, and its state-of-the-art inspection equipment helps ensure reliability and consistency of the finished product, while reducing visual manual inspection time.
The Antares inspection system uses 17 integrated cameras to perform advanced, high-speed quality inspections. This helps innovators improve product reliability, maintain high sterility standards, and reduce the risk of defective products reaching the market.
What This Means for Drug Developers
- Particulate inspection: The system checks for tiny particles or foreign contaminants inside vials and bottles that could compromise product safety or sterility. This helps ensure injectable drug products meet strict pharmaceutical quality standards.
- Cosmetic inspection: The machine inspects containers for visual defects such as cracks, scratches, and dents. Identifying these defects early helps maintain product quality and prevents compromised products from reaching patients.
- Container closure integrity testing (CCIT): The system verifies that vials and containers are completely sealed and free from microscopic leaks that could allow contamination,
moisture or air into the product. Uniquely, this technology combines CCIT with visual inspection. This is especially important for sterile injectable drugs, where maintaining
container integrity is critical for patient safety and regulatory compliance.
The system uses vacuum and pressure leak testing methods capable of identifying
microscopic defects without damaging sensitive powder products – an increasingly important capability within modern sterile manufacturing standards.
The inspection platform can process up to 18,000 vials per minute while automatically rejecting defective containers in real time.
Automated Secondary Packaging and Serialization
The last, but just as important step on the commercialization journey is secondary packaging; ensuring the final product remains traceable, compliant and secure through shipping. This final step is delivered through automated systems from Romaco and Optel, supporting efficient packaging and end-to-end product traceability.
The Romaco packaging system initiates the secondary packaging processes, including loading finished products into eco trays and preparing them for distribution. Paired with Optel’s serialization platform, each unit is assigned and verified with a unique identifier, enabling full track-and-trace functionality across the supply chain.
What This Means for Drug Developers
- Automated secondary packaging: The Romaco system efficiently packages finished products into eco trays, supporting efficient handling, reduced manual intervention and scalable packaging operations.
- Unit-level serialization: Optel’s serialization system assigns a unique identifier to each unit, enabling full traceability from manufacturing through to distribution and dispensing.
- Track-and-trace capability: Products can be verified at every stage of the supply chain, helping prevent counterfeit products and ensuring only authenticated medicines reach patients.
- Regulatory compliance: The serialization system supports global regulatory
requirements, including FDA and EU standards, as well as evolving Health Canada regulations for serialization and traceability.
De-Risking Pharmaceutical Manufacturing at Scale
One of the CMPC’s biggest advantages is its ability to support scalable manufacturing while maintaining process consistency. Scaling production introduces significant operational complexities.
As batch sizes increase, manufacturing systems must maintain:
- Consistent process parameters: Critical manufacturing settings such as temperature, pressure, mixing speeds and fill volumes must remain stable as production scales up. Maintaining these parameters ensures the product performs the same way at commercial scale as it did during clinical manufacturing.
- Automation logic: The programmable systems controlling the manufacturing process must scale accurately alongside production volumes. If automation logic is not properly aligned, efficiency losses, production errors or quality inconsistencies can occur during scale-up.
- Fluid dynamics: As production volumes increase, the movement and behavior of liquids within tanks, tubing and filling systems can change significantly. Maintaining proper fluid dynamics is essential to ensuring uniform product quality, accurate filling and reliable manufacturing performance.
- Mechanical handling: Equipment handling vials, bottles, stoppers and packaging materials must continue operating smoothly and precisely at higher production volumes. Consistent mechanical handling helps prevent product damage, line
stoppages and variability in the manufacturing process.
If these variables are not properly aligned, companies can lose substantial time during tech transfer and commercialization.
The Critical Medicines Production Centre was designed from the ground up to address the complex challenges of modern pharmaceutical manufacturing. It supports a stepwise approach to quality, aligning with each stage of clinical development and enabling a seamless transition to a fully GMP-compliant environment at the commercial stage.
Backed by a team of experienced industry experts, the facility was intentionally built to reduce operational risk, improve scalability and help innovators avoid common manufacturing and commercialization pitfalls.
Its integrated systems and programmable logic controls (PLCs) help ensure that processes developed at smaller clinical scales can transition efficiently to commercial production without sacrificing quality, consistency and efficiency. We also offer QA consulting for pharmaceutical manufacturing in GMP and customer GMP environments, helping ensure compliance and operational readiness at every stage.
This level of foresight positions the CMPC as an excellent choice for innovators
seeking reliable, scalable, end-to-end drug development support.
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API combines integrated CRO/CDMO services with the manufacturing capabilities of the CMPC. Connect with our team to get started.
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