Pharmaceutical Contract Manufacturing

Aphton Corporation Autoimmune Inc. Bioprogress Technology International BIORELIANCE CORPORATION Cephalon Inc.

Covance Inc. Martek Biosciences Corporation Metra Biosystems, Inc. Mylan Laboratories Inc. Neurobiological Technologies, Inc.

Penford Corporation Penwest Pharmaceuticals Co. PT Kalbe Farma PT Tempo Scan Pacific West Pharmaceutical Services Inc.

Guide to Pharmaceutical Contract Manufacturing

By John Williams
Contract pharmaceutical companies can provide the flexible links you need to forge a more agile supply chain

Pharmaceutical contract manufacturing can give you the agility you need to compete in today's global marketplace. Contract manufacturers in the drug industry can provide a relief valve from market pressures such as patent expiration and the demand for generics, discovering off-label uses for current formulas, pressure to speed up clinical trials, or keeping abreast on the development of new processes.

Outsourcing to contract manufacturers in pharmaceuticals can answer some of the bigger challenges in today's global market:

1. Pharmaceutical contract suppliers around the world (particularly India and China) multiply the manufacturing capacity to match growing demand from emerging markets, especially Africa.

2. New technologies in drug delivery systems allow for reformulations of existing products - opening up pharmaceutical formulation possibilities to "mix and match" drugs and delivery devices that will extend product life cycles.

3. With new demand from new markets and new diseases comes new regulation, as governments step in to monitor and control the development and manufacturing process. Pharmaceutical contract manufacturers who specialize in clinical trials can alleviate that concern.

4. Even packaging benefits from technology, particularly RFIDs to ensure more accurate and safer supply chain logistics.

Action Steps

The best contacts and resources to help you get it done

Find a drug contract manufacturer that provides a full-service menu Avoid using a pharmaceutical contract manufacturer too small to handle more than one job, leaving you with the headache of managing a long supply chain with small links. A pharmaceutical manufacturing company today should be able to handle a number of tasks, allowing you to concentrate on higher-end R&D.

I recommend:  Located in Canada, Contract Pharmaceuticals Limited concentrates on customer-centric, full-service outsourcing, from manufacturing and packaging to testing services. NHK Laboratories, Inc. manufactures a wider variety of products, in both the pharmaceutical and "nutraceutical" market - both dietary supplements and functional foods.

Match the contract manufacturer to your pharmaceutical formulations Choose a drug contract manufacturer that can handle the level of complexity your product development team specializes in.

I recommend:  Ben Venue Laboratories claims the lead in freeze-drying and vacuum-drying sterile pharmaceuticals. Biotest Laboratories' ISO-accredited services include consulting and training along with product testing, cleanroom certification and contract manufacturing.

Go global in your search for drug contract manufacturers Not only does outsourcing make sense financially, but an individual company must now consider the political landscape when outsourcing. Source contract manufacturers either as close to your products' markets as you can, or in a neutral territory. Also maintain multiple outlets, as global hot spots wax and wane - any given region can be a political asset one moment and a liability the next.

I recommend:  Aurobindo Pharma Ltd. claims to be one of the largest vertically integrated pharmaceutical manufacturers in India. Located in Switzerland, ADD Technologies Ltd concentrates on delivery systems for the pharmaceuticals you develop.

Tips & Tactics

Helpful advice for making the most of this Guide

• Spend time up front mapping out the supply chain, fully understanding the capabilities of your chosen pharmaceutical manufacturing companies. Once you've defined your product and process, standardize it across all parties, to smooth the flow of development, manufacture and distribution and ensure all parties comprehend their place within the cycle.