Selecting a CMO: Top ConsiderationsDec 16, 2016
Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. You’re putting your supply chain, your brand’s reputation, and patient safety in a partner’s hands. Here are some tips to increase confidence in your decision and ensure a successful outcome.
Know what you need. Are you looking for a tactical contractor to handle a single project or fill gaps in in-house capabilities? Do you want to establish a preferred provider relationship, to reduce CMO (change CMO to CMO in all instances) evaluations and decisions for every external project? Or are you looking for a strategic partnership, which is defined as a long-term relationship between organizations to achieve defined business objectives by maximizing the effectiveness of each participant’s resources. Each type of engagement offers its benefits, but strategic partnerships establish lasting working relationships that solve problems more quickly and find new, innovative solutions more efficiently due to the common goals and high level of transparency between the parties. This type of partnership is one that is being sought out in many areas; in fact, a recent survey found that 73 percent of emerging pharmaceutical companies were interested or very interested in establishing strategic partnerships with CROs or CMOs over the following 12 to 18 months. In addition, American Pharmaceutical Review, in a January 2016, had this to say: It is also worth noting that many sponsor firms are looking to simplify their CMO networks by working with CMOs that can support their projects from the development phase through clinical trials and on to commercial API production, as well as drug product formulation, manufacturing, and packaging. The pharma-biotechs are establishing more collaborative relationships with a smaller set of carefully selected, preferred suppliers. Such an approach, unlike the use of a large number of tactical suppliers, leads to simplification of the supply chain for increased management, and reduced costs and development timelines. CMOs with fully integrated capabilities and cultures, systems, and processes that support these types of collaborative relationships are an important component of this type of outsourcing strategy.
Look for well-integrated breadth and depth. Regardless of the type of relationship you need, it is still important for CMOs to offer well-integrated services. Look for outsourcing services that scale from formulation and method development all the way to commercial manufacturing and packaging, across a wide range of products, for example, from drug product and APIs to biologics, fermentation, and packaging. Can they manufacture at various scales inclusive of both boutique and blockbuster drugs? High-selling brands, innovative biologics, and in-demand generics? Can they offer clinical and commercial scale? How well integrated are all their services, to ensure a smooth transition from development to commercial?
Hire the right expertise. You want access to a wide range of expertise that should supplement and enhance your own knowledge. Look for a strong combination of scientific, regulatory, technical transfer, project management, supply chain, and project-specific expertise. How knowledgeable is the CMO in protecting IP, gauging risk and enlisting the latest operational methods? When it comes to solving inevitable hiccups along the way, does your CMO have the deep understanding of your product and processes to redirect and resolve issues – quickly, confidently, and cost-effectively? A dedicated project team should be assigned to your project(s), including the proper communication tools necessary to strengthen the partnership, increase transparency and speed to achieve project deliverables.
Inquire about experience. Read the research, get referrals, perhaps even hire a consultant to help evaluate CMOs – what’s important here is to learn how their experience matches your needs. For instance, Life Science Leader publishes the top CMOs every year based on client feedback. This can be a valuable resource to validate the quality of a CMO. How long as the CMO been serving clients? What kind of clients do they have, and what kind of projects have they successfully handled? What therapeutic areas have they worked in, developing what dosage forms, for what markets? How do they respond when challenges or issues emerged? And how do they communicate and work with sponsors at these times? It’s one thing to line up capabilities against your requirements, but another to know your CMO is not cutting its teeth on your project, or less than reputable at managing through challenges.
Confirm their resources. Not only do you want assurances your CMO has the financial stability to support the lifecycle of your product, you’ll also want to know that the CMO has a robust and qualified supply chain to protect you from uncertainties. It is also important to evaluate their facilities and equipment, check for cGMP manufacturing capability, and verify capacity availability against your development and commercial timelines. Especially for preferred providers or strategic partners, where future project capacity cannot be immediately determined, make sure your products are your CMO’s priority.
Ask for proof. It’s the age of data, when everything conceivable is measured. Ask your CMO what kind of KPIs they have in place and about their track record in meeting client expectations. Does the CMO collaborate with sponsors on KPIs to determine how best to measure, track and report on performance, from meeting timelines to final product quality?
Check the regulatory record. This is obvious, but important. How often has the CMO been audited, inspected, or investigated in the past one to five years? What’s its record with regulatory agencies? And what regulatory approvals are in place, to determine their geographic reach to global markets?
Evaluating a CMO takes time and dedicated effort. Contact us to learn more about AbbVie Contract Manufacturing's experience, expertise, resources, regulatory record, and more to determine if we’re the right CMO for your tactical or strategic needs in biologics, potent, drug product, fermentation, hot melt extrusion, prefilled syringe and APIs, from development through clinical and commercial manufacturing to packaging.