Published in Life Science Magazine, 1/2004
Written by Viktoria Cassersten, Market Communications Officer, Cambrex Pharma

- The chemistry required to manufacture life-saving active pharmaceutical ingredients (APIs) but it can be demanding and complicated. Cambrex Pharma offers the integrated safe handling solution, says Ann Gidner, Director of Commercial Development and Marketing.

Cambrex is a global, diversified life sciences company dedicated to providing innovative products and services to accelerate drug discovery, development, and manufacturing processes for its customers focused on human health and the prevention of disease. The company employs over 1900 worldwide. Cambrex Corporation is organized into four business units to better serve the unique requirements of its customers. One of the business units, Cambrex Pharma, provides custom development and manufacturing services to pharmaceutical companies using an organic chemistry technology platform. One of the largest sites within Cambrex Pharma is Cambrex Karlskoga in Sweden.

The Safe handling concept includes High Energy, Controlled Substances and High Containment.

High Energy
Many APIs are based on processes and compounds that are highly energetic, which means that they can be both complicated and dangerous to handle.
- We are one of few suppliers in the world that can safely handle these explosive processes under cGMP. Cambrex Karlskoga has its origin in the technology of Alfred Nobel and has  proudly managed his heritage and built upon this competency to manufacture active pharmaceutical ingredients, comments Ann Gidner.
Cambrex Pharma has in-house safety testing, advanced scale-up models and a remote controlled plant.

Controlled Substances
Some pharmaceutical ingredients have the potential for abuse.  As a result, all manufacturing and handling of these materials must comply with strict regulations and controls to avoid diversion.  Certain examples of these types of therapeutics are amphetamine derivatives (for the treatment of attention deficit and hyperactivity in children), morphine (for pain relief), and other products used for pain management. Certain facilities have been certified to handle these controlled substances, including the needed administrative competency and special storage.
- Many pharmaceutical companies outsource the production of controlled substances, since they do not have the capabilities in-house, says Ann Gidner.

High Containment
Active Pharmaceutical Ingredients that require high containment are substances that have drug effect at microgram level, which means they are highly potent.  These processes require specialized containment to ensure that employees and the environment are protected from exposure. Facilities within Cambrex Pharma handle highly contained processes under safe cGMP conditions.

Many oncology drugs used to treat cancer are highly potent and need to be manufactured in a high containment area.
- Oncology is a future area since the cancer research is making a lot of progress for each year passing by. We would like to be part of it and contribute to new pharmaceuticals, says Ann Gidner. 
Cambrex Pharma is expanding their capabilities and building a new cGMP kilo laboratory to manufacturing APIs for oncology drugs.