Finding The Right Contract Manufacturer

By Vetter Pharma-Fertigung GmbH & Co. KG

Finding a suitable contract manufacturer is, perhaps, one of the most viable options. The pharmaceutical company can concentrate effort and money on research and development and marketing, while the contract manufacturer takes care of the manufacturing process, including validation, support for license application and packaging. In addition, outsourcing can be scheduled into the strategic planning of a drug's lifecycle. During the early development phases, which last years, a partner with the necessary facilities and experience can be sought out and brought onboard. Finding the proper partner requires careful screening, hence a certain amount of time. A number of criteria should be met. The fi rst is simply know-how and experience: How long has a contract manufacturer been in the business and what kind of work has the company done, i.e. with what kind of drugs. The more experience, the smoother the collaboration. Finally, to ensure effective workings, outsourcing has to be made an integral aspect of project management.

The manufacturing processes involved in fi lling syringes, vials and cartridges is one of the most complex and diffi cult procedures in the pharmaceutical world and serves as an excellent example of what might be needed for a successful partnership. If a company is intending to put a parenteral drug on the market, then, the entire manufacturing process in fact becomes the best candidate for outsourcing, since it is very costly, involves an extremely wide range of procedures and needs a lot of experience. It involves such steps as matching the product's active substance with its mode of administration, process development and transfer to commercial manufacturing. There are several keys to success: including the requirements for the future commercial manufacturing in the initial development phase, and having a precise project plan, competent project management and an effective filing strategy in order to speed up time to market.

Most pharmaceutical companies, but especially the smaller biotech fi rms that produce niche drugs, will not have the capacity nor the fi nancial strength to maintain, much less build, any capacities for manufacturing. This is especially true in light of the regulatory constraints. While the only real alternative is indeed using the services of a contract manufacturer, a drug company cannot just look one up in the phone book and take the first one, of course. The candidate will have to fulfi l a number of important criteria, including a sound expertise of aseptic filling from development to commercial manufacturing, an extensive knowledge of validation procedures, an excellent relationship with regulators, and even a knowledge of marketing.