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.
