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The contract manufacturer must have sufficient capacity so it can absorb possible surge in demand, and back-up capability in case of a power failure or other event.
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.
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.
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.
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.
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.
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.
Outsourcing is an important strategy in the pharmaceutical industry to meet the growing number of challenges. Because the outsourcing relationship is long-term, it influences future lifecycles of a drug and requires investments of time and money. It is a fundamental decision that must be made in the early phases of a drug's development, when there is time to find the right partner and develop a strong relationship. A good contract manufacturer provides the necessary support throughout all stages of a drug's development. It gives the pharmaceutical company the time and resources to focus on its core business—researching and developing lifesaving drugs and marketing them.
Max Horn is a managing director at Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany, +49.751.3700.0.