Taking the Next Step with Contract Manufacturers July 2008

Pressure is bearing down on all sides. Pharmaceutical and biotechnology companies face stress from increasing costs, intensifying global competition, growing regulatory stringency, and more. For years, pharmaceutical and biotechnology companies have relieved a little of that pressure by outsourcing functions to a limited extent, such as in packaging or distribution. Allowing a contract manufacturer to perform some of these operations frees up companies to focus on their core competencies.

Today, however, some of the industry’s most eye-opening success stories are the result of even more extensive outsourcing strategies. Effective outsourcing in the biotech and pharmaceutical industries requires more than simply finding a contract manufacturer who can perform restricted tasks. For a truly successful outsourcing strategy, companies must find a true partner.

Contract Manufacturing Basics

Of course, this all starts with effective and reliable manufacturing techniques. By choosing the right contract manufacturer, companies can actually improve their products and gain faster regulatory approval.

Vetter Pharma-Fertigung GmbH & Co. KG has served as an independent contract manufacturer for over 25 years. The company specializes in aseptic filling of syringes, cartridges, and vials, including product lyophilization. In addition, Vetter provides its own patented technologies, which can help clients to further improve their competitive positions. Besides syringes, vials, and cartridges, Vetter offers Vetter Lyo-Ject® dual-chamber syringes and V-LK® cartridges for lyophilized products. The company has also designed and implemented special closure systems, such as the V-OVS NS®, to prevent tampering. Furthermore, Vetter has become a leader in state-of-the-art filling technologies such as the Restricted Access Barrier System (RABS). Vetter can also boast a stellar reputation with regulatory authorities, backed by 19 successful inspections by the U.S. Food and Drug Administration. As a result, Vetter clients often have an easier and quicker access to the marketplace than others do.

Pushing the Outsourcing Envelope

Choosing the right contract manufacturer can certainly bring a pharmaceutical or biotech company better technology, and it clearly can assist with regulatory approval. But in today’s competitive marketplace, the benefits do not stop there. The most effective contract manufacturers offer even more through long-term partnerships with their clients. Vetter, for example, goes far beyond mere packaging. The company has transformed itself into a full-service provider that can help clients reduce time to market and manage product life-cycles. One of its divisions, Vetter Development Service (VDS), supports clients’ products from development all the way to market introduction. This participation in product life-cycle management (PLM) provides a wide range of benefits. VDS also works with clients to carefully plan and coordinate product development steps. This can add up to a reduced time to market, which translates into real savings that impact the bottom line.

To define long-term product life-cycle management for their customers, contract manufacturers must have a broad portfolio of innovative products. ()

In addition, VDS can help clients improve their competitive positions over the life-cycle of a drug. With patent expirations shortening and patents being challenged earlier after new drugs enter the market, little time is left to recoup investments. Planning ahead can make all the difference. Vetter’s product portfolio and development know-how offer the option of creating a powerful PLM strategy that can help a drug to remain competitive well into the future. At Vetter, PLM planning begins during the development phase, although options are also available once a drug is on the market.

Only experienced contract manufacturers can provide such a wide range of services. As a result, pharmaceutical and biotech companies willing to search out and partner with the right contract manufacturer for their own needs can dramatically strengthen their market positions.