Complete capability CMC Biologics

COMPLETE CAPABILITY

Contract biopharmaceutical manufacturer and developer CMC Biologics A/S is highly competent in delivering complete biologics to customers worldwide. Emma-Jane Batey spoke to vice-president of business development, Roland Hecht, to see how this ambitious company is planning continued success.

Established in Copenhagen in 2001, CMC Biologics A/S today has more than 350 employees and over 60 clients worldwide. A key step in its global development came in 2007 when it acquired the US contract manufacturing arm of the ICOS Corporation, ICOS Biologics, which has further enhanced its ability to develop, manufacture and deliver high-quality biologics across five continents.

A complete end-to-end biologics capability is the foundation on which CMC Biologics’ success has been built. The company has continued to add standalone possibilities to its offer, resulting in a wider client base and a broader portfolio. Vicepresident of business development, Roland Hecht, explained to Industry Europe how this has been achieved. He said, “We are still in a very exciting growth period, which has been going on for some time! We have been focusing on ensuring we can offer our clients worldwide the best of both a full biopharmaceutical contract manufacturing service and the ability to pick and choose standalone elements if they prefer. We can work with clients on any aspect of their biologics development and manufacture.”

Mr Hecht pointed out that the intense phases involved in getting a biologic product ready for the commercial market are perfectly suited to CMC Biologics’ skilled and experience workforce. He said, “When a new pharmaceutical drug is being developed, there are all manner of tests, phases and improvements needed to get the drug to the point where it

Quality Research Deserves Quality Logistics Please Let Us Help You Succeed

CMC Biologics A/S and World Courier

For several years CMC Biologics A/S and World Courier have worked together, supporting the research, development and transport of time and temperature sensitive samples and products done by CMC Biologics and its partners throughout the world.

During the time World Courier has been entrusted more than 1000 temperature controlled shipments ranging from 0,1 kilo to + 1.000 kilos.

Each shipment transport tailor made with best possible means of transport and routing, utilizing our entire range of qualified packaging from Dryshipper (Cryo), over Dry Ice handling to + 20 ULD containers and a fl eet of highly qualified temperature controlled vehicles.

Supporting the SOP framework of CMC, we have taken on every day logistic challenges ranging from high value, one of a kind samples, APIs, harvest samples, to vials and powders.

Serving destinations on every continent, and the affiliated challenges within documentation and local legislation.

World Courier Profile

World Courier delivers its specialized logistics services across the full “life cycle” of the clinical trial process, beginning with pre-trial coordination between biopharmaceutical companies, CTSs, CROs and Central Labs.

The company then manages the logistics and transport of all trial materials, packaging, scheduling and routing. Once a trial is underway, World Courier assists with regulatory and permit issues and manages the import of bulk drugs and supplies into centralized storage depots.

We also handle the intra-country distribution from investigational drug storage depots to clinical trial research sites, coordinate patient sample logistics, and manage drug return and destruction procedures. Represented in more than 50 countries with 152 owned offices, we maintain a 24/7 support for our clients.

Clinical Trial Supply Depot Network:

With company owned GMP compliant facilities, comprehensive SOPs and a proprietary CTM management software system, we offer an unparalleled service.

We are strategically located in Australia, China, India, Latin America, Russia, Japan, Singapore and South Africa to help in the most demanding regulatory environments.

World Courier Ground Europe: Specialists in intra-European temperature-controlled ground transport for the pharmaceutical, biotech and healthcare industries.

Utilising state-of-the-art refrigerated vehicles, highly trained drivers and staff, continent-wide SOPs and advanced telematics including realtime satellite tracking, WCGE also provides customers with the added assurance of complying with all relevant GDP/GMP guidelines as required by EU regulatory agencies.

Core service offerings focus exclusively on premium on-demand 24/7 transport services within Europe for the distribution of temperaturesensitive clinical trial, bulk product and fi nished product shipments at all critical temperatures ranges.

GxP compliance - QMS

The basis of World Courier’s GxP Policy rests largely with established precepts of Good Distribution Practice (GDP), Good Storage Practice (GSP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) as they relate to each business individually (transport and storage) and follows all relevant guidance documents supporting these practices.

World Courier has also put in place an independent Quality Management System that complements its GxP policy and conforms to leading international quality management and oversight programs. World Courier also complies with other quality systems such as the ISO 9000 series.

can be commercially approved by the relevant health authority. With our teams able to offer both the testing and the development of biologics on a contract manufacturing basis, we have created an enviable list of leading clients.”

Investment in excellence

CMC Biologics is committed to ongoing investment in its state-of-the-art facilities. Mr Hecht continued, “We have two sites – our original facilities in Copenhagen and our site in Seattle which we acquired with ICOS. Both of the sites are fabulously well-equipped to enable us to continue our work. Part of the reason we are achieving such impressive growth is the fact that we have these excellent facilities.”

In 2011, the Seattle site underwent a major rebuild. This major investment programme guaranteed that CMC Biologics could make a better process flow for commercial production for its clients across North America as well as for a growing list of clients in Asia.

Mr Hecht told Industry Europe how plans for further investment in CMC’s Copenhagen site will be completed in the next two years. He said, “We are investing nearly €5 million in our Copenhagen site to offer a unidirectional product flow. This will ensure that our internal clean rooms are totally pure: we will have different entrances and exits so that there is no cross over of either personnel or materials, making CMC Biologics one of the cleanest, purest facilities in the industry.”

Mr Hecht continued, “Investment is needed on both the commercial and the production site to support future success. We are committed to being a commercial biopharmaceutical contract manufacturer and a reliable partner for our clients, so we take our ongoing investment and personnel training programmes very seriously.”

Small scale to large scale

CMC Biologics’ facilities and capabilities mean it is able to deliver whole or part development projects for small scale to large scale manufacture. The company works closely with its

pharmaceutical clients in order to understand their precise requirements, and it then works with its highly skilled staff and extensive technical facilities to deliver the commercial product.

The ongoing success and continued investment will help to maximise CMC Biologics’ future potential. The company has ambitious plans to work with new global pharmaceutical clients as well as continuing to maintain strong relationships with its existing clients. A new site is also expected to be acquired and upgraded in California as part of an expansion plan in the USA. Mr Hecht concluded, “We aim to further our global reach in terms of client development and it is up to us to build positive relationships with more large pharmaceutical companies as well as small to mid-sized bio companies that are looking to develop products with an experienced global partner. CMC Biologics is already in the global top ten of biotechnical contract manufacturing companies, but we want to be in the top five within the next five years. We believe that our capabilities, our investment, our personnel and our excellent client partnerships will help us to make this happen.” n