Outsourcing issues: the multi-product challenge

By Arthur C. Solomon
N/A

Forecasts show some 300 new FDA drug approvals during the next decade, based on the unprecedented flow of about 3000 new compounds into the pipeline. A majority of these are anticipated to be relatively small-volume products. Most are also expected to be outsourced for manufacturing and development.

Whether in development, clinical trials or commercial production, this product flow creates an extraordinary demand on contract manufacturers and developers. To effectively serve their customers in this multi-product environment, they must be able to manage a large number of projects and clients simultaneously.

It will not be by accident that contractors develop the skills to provide the necessary expertise; it will be by conscious consideration of needs. As more products enter the pipeline, pharmaceutical and biotech companies will need to take a closer look at this ability and ask the right questions:

• How well does the contractor handle scheduling?
  
• Are they realistic in allocating, equipment, personnel and other resources?
  
• Have they over-extended their capacity?

Delays may be considered by many as part of the process, but when time-to-market is a primary concern, it pays to have a contractor who knows how to schedule. How does the contractor handle set-up and clean-up between runs? Whether the product is lyophilized or liquid, product separation and differentiation are keys to product integrity. Contractors in a multi-product environment need to practice good manufacturing practices to maintain integrity for every product with which they are involved. Is the contractor's plant and equipment designed for maximum flexibility and rapid changes? Older facilities that have not been renovated may not be configured for this new multi-product environment. And even newer facilities have to be designed to take these needs into considerations.

Taking a close look at a contractor's records and inspecting the facilities with an eye for flexibility and rapid change will help to assess a contractor's ability to handle your needs. It is also a valid point for discussion when you begin the contractor selection process. If they are prepared to handle the challenge, contractors will be happy to show that they have developed a clear strategy to meet the demands of a large number of projects.

For more information: Arthur C. Solomon, Director of Business Development, SP Pharmaceuticals LLC, 4272 Balloon Park Rd. NE, Albuquerque, NM 87109. Tel: 505-761-9230. Fax: 505-761-9229.

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