The available portfolio of solutions is critical. A contract manufacturer with a full range of products will possess the necessary
flexibility to address the needs of the market. A basic portfolio should include single-chamber syringes, vials, and cartridges.
Any additional, innovative products are a plus, such as tracking systems that allow a product to be traced from the filling
line to the patient, and antitampering solutions. These are especially important in life-cycle management. If a lyophilized
drug is to hit the market fast in a first cycle, it will probably be in a vial. For the second cycle—depending on the product—the
drug company may opt for a more patient-friendly form like a dual-chamber syringe or cartridge. A viable contract manufacturer
will have these capabilities on hand. Lifecycle management is an aspect that should not be underestimated: if planned early
enough, it can mean the success of a drug against upcoming competition.
Assuming a candidate company fulfills all of the "hard" criteria, there remains a number of other areas to consider: Know-how
and experience in manufacturing must be just as up-to-date as the facilities, and well trained teams of scientists and engineers
are a must. They ensure a competent and creative approach to solving problems. They also contribute to speeding up time-to-market.
A well-versed team can work more efficiently; it has complete checklists for all processes and can organize each element so
that no time is wasted.
Another criterion for a good contract manufacturer is the company's market reach. How positioned is it internationally? The
pharmaceutical industry in each country has its own regulatory systems and its own national specifications. But if a contract
manufacturer has already filed for drugs sold globally, it is safe to assume that it has integrated its experience into its
processes. Furthermore, it already will have established a solid working relationship with regulatory authorities. This can
save a lot of time and effort when it comes to validation and seeking approvals.
Having documented approvals by international regulatory agencies, such as the Food and Drug Administration (FDA), the European
Agency for the Evaluation of Medicinal Products (EMEA), and other authorities is essential, especially if a drug company is
trying to reach an international market. It is just one more element that can chip away at time to market, which can save
a drug company a fair amount of money.
Finances for the Long Term
The financial stability of a potential contract manufacturer is crucial, and somewhat related to the need for back-up. Manufacturing
a drug is not a one-shot event, or a brief one. In the best-case scenario, a drug can take less than 12 months from first
feasibility and process development to commercial manufacturing. In other words, a drug company is looking at a long-term
relationship with the contract manufacturer. It should be able to show that it has independent financial staying power. A
contract manufacturer with a history of organic, consistent growth generally proves to be a strong ally.
Benefits of Partnership
Manufacturing drugs, especially new, innovative, "high-tech" substances, involves considerable risks, first and foremost,
financial: Will the drug be a success? Establishing a productive and balanced relationship with a contract manufacturer means
sharing possible risks. It involves regulating scenarios in the event of a boom, or, should the product encounter problems,
slowing, or even halting, production. The contract manufacturer should have the experience, which reduces trial and error.
Once the product is launched, the contractor is responsible for harmonizing production and demand.
Adopting a sustainable outsourcing strategy can lead to a perfect win-win situation, but it also requires an investment from
both parties. A contract manufacturer needs the experience to be flexible and innovative. Integrated management is required
to make sure each project is being handled properly and that communication channels are open. Regular planning sessions must
be held to ensure that each party is fully informed of any potential roadblocks. All processes carried out by each party must
be carefully documented. One of the best ways to keep track of a project's progress is to jointly establish performance measures
that can be easily quantified using objective data And because the pharmaceutical company will be sharing confidential data,
the true core of any partnership is trust.