Thursday, May 1, 2014

Solid Infrastructure Benefits Canadian CMOs


 
Peter Pekos,
CEO, Dalton Pharma Services

People in the global pharmaceutical industry who are informed recognize that Canadian contract manufacturing organizations (CMOs) have an advantage over offshore competition.  Basic risk management considerations favor Canadian CMOs because of the infrastructure and culture within Canada. When you add strong IP protection, stable utilities, transportation links to global markets, a high level of ethics, deep-rooted worker and environmental protection, and an excellent regulatory framework, sponsors can have a high degree of confidence in Canadian drug development and manufacturing organizations.

Canadian drug manufacturing facilities that are licensed by Health Canada engender confidence because of the high standards demanded by Canadian regulators. GMP compliance in Canada is recognized by 22 EU member states as being equivalent to their standards, and vice versa.  Drug coverage under this mutual recognition agreement includes prescription and non-prescription drugs, vaccines, and biotherapeutics.  The reciprocity facilitates and simplifies the entry of Canadian made drug products into a large number of countries.

Health Canada is an active participant in global regulatory alignment.  Since more than 70% of drug ingredients come from overseas suppliers, regulatory agencies in most countries are now regulating active substances.  In 2013 Health Canada implemented new legislation that makes all Canadian establishments subject to GMP requirements for APIs.  This includes establishments involved in the manufacture, packaging, testing, and importing of APIs, as well as those which import APIs to manufacture finished dosage forms.

One of the recent trends that I find particularly pleasing is the recognition by Canadian federal and provincial governments of the importance of CMOs in the pharmaceutical development supply chain.  This higher profile is well deserved and due in large measure to the hard work and entrepreneurial activity of Canadian CMOs who have expanded and diversified their offering.  For example, as big pharma consolidated manufacturing sites and downsized, excellent pharmaceutical development and production facilities in Canada were vacated.  Some CMOs took advantage of this situation, acquired these facilities, and used them as a base upon which to build substantial contract operations.

What has been steadily evolving is a strong Canadian ecosystem to support R&D development and commercial production for domestic and foreign clients.  These capabilities have by necessity focussed on the development of highly specialized, complex manufacturing processes and the production of a remarkable diversity of therapeutic agents.

Dalton Pharma Services is a Canadian CMO that provides cGMP manufacturing of solid dosage forms and aseptic filling of vials and syringes.  To reduce development time, we offer in the same facility integrated services from discovery to commercial production. This includes medicinal chemistry, process optimization, API manufacture, formulation development and a full range of analytical services.  Since the founding of the company over 27 years ago, we have grown and evolved to better serve our global client base.  A $2.5 million expansion that increases our capability and capacity for aseptic filling has just been completed.  Over the next four years we plan further expansion to add to our range of specialized powder filling services. 

Like several other Canadian CMOs, Dalton seeks out and obtains clients which provide good bench to production opportunities in complex, specialized, low volume, high margin products.  The niche products in our development portfolio include specialized powders, controlled substances, and therapeutic vaccines.  One of the very satisfying aspects of our business is that we have the opportunity to play a key role in the development of some truly innovative drug products designed to meet the needs of underserved patient populations.

Drug discovery and development are difficult, and it is gratifying that we have been able to help reduce the risk for our clients, improving the likelihood of the creation of successful therapeutics. To date we have injected over $150 million into the Canadian economy.  While part of this success can be attributed to positioning as a premium vendor with a very strong quality and regulatory emphasis, there is no doubt that my company has benefited greatly from the supportive infrastructure that we enjoy in Canada.