Contract manufacturing became popular in many industries during the 1990s as a way to meet rising costs and to retool. The
pharmaceutical industry has been slow to adopt this practice because of its absolute need for secrecy.
However, with fewer blockbuster drugs in the pipeline, companies are on the lookout for an enduring solution to meet market
challenges. These include rising process costs resulting from stricter quality control criteria, evolving technologies, which
are becoming more complex and costly, and the increasing stringency of regulatory standards. To maintain or expand market
shares, pharmaceutical companies must devise new strategies to remain competitive.
Finding a suitable contract manufacturer is one of the most viable options. It allows the pharmaceutical company to focus
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. Typically, a company contracts with a partner with the necessary facilities and experience during the
early development phases. Finding the proper partner can be time-consuming, because it requires careful screening and assurance
that the prospect has the right know-how and experience: How long has a contract manufacturer been in the business? What
kind of work has it done? What kind of drugs? The more experience it has, the smoother the collaboration.
The manufacturing processes involved in filling syringes, vials, and cartridges is one of the most complex and difficult procedures
in the pharmaceutical world and exemplifies the requirements for a successful partnership. If a company intends to put a parenteral
drug on the market, the entire manufacturing process becomes an excellent candidate for outsourcing. The process is costly,
involves a wide range of procedures, and requires a company with a great deal of experience. Manufacturing parenterals 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 in outsourcing: be sure to include requirements for future commercial
manufacturing in the initial development phase; develop a precise project plan with a competent project management team; and
adhere to a sound filing strategy to speed up time to market.
Basic Outsourcing Principles
Most pharmaceutical companies, but especially the smaller biotech firms that produce niche drugs, do not have the capacity
or financial strength to maintain—much less build—capacities for manufacturing. This is especially true in light of today's
regulatory constraints. The contract manufacturer will have to fulfill a number of important criteria, including extensive
knowledge of aseptic filling from development to commercial manufacturing, knowledge of validation procedures, an excellent
relationship with regulators, and even knowledge of marketing.
Beyond these basic criteria, what else makes a good contract manufacturer? The facility itself must be state-of-the-art, so
it can provide the highest quality work, which in turn facilitates validation. It needs laboratories and an elaborate concept
for clean rooms. For example, up-to-date technology for performing aseptic filling, such as lines equipped with a restricted
access barrier system, is an advantage for several reasons: it is the safest available and offers great flexibility in filling;
it shows that the contract manufacturer is on the front lines of innovation in the business. The contract manufacturer must
also have sufficient capacity so it can absorb a possible surge in demand, and it must have back-up capability, in case of
a power failure or other possible events. Filling facilities must be equipped with an effective back-up power supply, a reliable
supply of spare parts, in-house engineering capabilities, media supplies, and so on. A very conscientious contract manufacturer
might even have more than one supplier, in case one cannot provide for some reason. Furthermore, having additional filling
lines does not suffice for total reliability: Back-up filling lines must be at another location several miles away in the
event of a catastrophic event.
Portfolio of Solutions
If a contractor has the capacity and safety through back-up systems, it is important to find out what additional services
and solutions are offered. The most efficient option is a program that starts with support in product development and considers
the lifecycle management of the drug. The contract manufacturer will ideally offer various options in primary and secondary
packaging, which can reduce time to market of a drug, removing some of the burden from the drug manufacturer.
