API grows pharma manufacturing capacity
Applied Pharmaceutical Innovation (API) has passed an important milestone in securing the Edmonton Metropolitan Region’s place as a global player in the pharmaceutical manufacturing sector.
The Drug Development and Innovation Centre facility has received a notice of Good Manufacturing Practice (GMP) compliance for a Drug Establishment Licence (DEL) following an audit by Health Canada. GMP certification is an important international manufacturing standard that is required to be able to produce pharmaceuticals that can be sold internationally. This news will dramatically enhance the region’s ability to attract investment into pharmaceutical manufacturing.
“This is a huge step forward for API’s efforts to develop security of supply manufacturing and support innovators in the commercial market.” says Applied Pharmaceutical Innovation CEO, Andrew MacIsaac, “Over the past 9 months we’ve been working around the clock to bolster our capacity to meet needs related to COVID-19 and we’ve now passed this significant milestone.”
While API’s facilities were previously appropriate for clinical trials, a DEL will enable the organization to work with products that are on the market – a critical licensing step in the efforts of API to establish production of Propofol and other drugs.
Propofol in particular, has seen a lot of shortages during the pandemic, and is a critical drug in the treatment of patients requiring the use of a ventilator.
“We’ve now got everything in hand to expedite the launch the Edmonton Metropolitan Region is home to a large concentration of chemical companies, world-class expertise, accessible health datasets from 4.5 million people and a university that is ranked 3rd globally in AI research,” says Andrew. “We’re well positioned to be an emerging hub for pharmaceutical R&D of products from our planned facility once it is funded.”
Chemical companies in the region such as Gilead and Rane Pharmaceutical, already manufacture smaller batches of drugs that are used in clinical trials. They also produce a lot of the ingredients needed for GMP certified facilities. Gilead’s Edmonton facility has been critical in producing Remdesivir. By establishing a GMP facility in the region, API is helping to secure the missing link that would complete the entire supply chain of pharmaceutical manufacturing in the region.
The region already has the infrastructure needed to supply the international market. The Edmonton International Airport (EIA) is the first airport in Canada to successfully secure CEIV certification for pharmaceutical handling through the International Air Transportation Association.
“Establishing the Edmonton region as a pharmaceutical manufacturing hub makes sense for a lot of reasons,” says Lynette Tremblay, Edmonton Global’s VP of Strategy & Innovation. “The region already has a unique combination of assets including infrastructure, expertise and government support. API’s certification unlocks the potential that exists for pharmaceutical manufacturing here.”
API and Edmonton Global are working with the Government of Canada and the Province of Alberta to secure funding for a new 40,000 square foot manufacturing facility.