Quite a Pair: BioPharma and CMOs

Whether you’re looking to reduce costs, minimize investments in facility development, improve efficiency or save regulatory headaches, contracting out your manufacturing projects may be the answer to any number of development pains. Still, it is important to remember that while outsourcing may be the answer for some projects, it may not necessarily be the right answer for others. There are a number of key points to consider during your strategic evaluation of whether working with a contract manufacturing organization (CMO) may be right for your organization, and further, which of your projects such a relationship might benefit. rnDeciding to outsource can be, and should be an in-depth process. Just as with any business partnership, it is generally a good idea to go into the partnership only after having thoroughly evaluated the state of your operations and taken into account the full picture of options before you. For this step, you’ll want to take a look at all of your projects, your goals, and of course weigh the cost and return differences. Not all projects and/or processes are suited for outsourcing, some may be best kept close to home. rnOnce you get into the actual process of interviewing CMOs for your project(s), Cook Pharmica recommends having senior-level tech leads on hand – those who understand the issues that come with the manufacturing process. They also suggest repurposing assets to help ease the inevitable anxiety of outsourcing, and accepting the added risk of not being fully in control of process development. As you choose which of your projects might be candidates for partnership with a CMO, here are just a few benefits to keep in mind: 1. Partnering with a CMO can reduce operational and infrastructure costs. Probably the most apparent benefit, this goes without saying, but we’ll say it anyway. Outsourcing to a CMO can help your business lower the cost associated with new development, such as building large manufacturing facilities which come with a hefty price tag. This benefit alone can be the true savior to fledgling research and development budgets. rn2. CMOs can allow you and your business to focus on the big picture: By giving up the control of the day-to-day manufacturing (and all the overhead that comes with it), you can now more efficiently manage all the internal resources and costs of your company by focusing on core competencies and the important, high-value projects while maintaining a smaller and more affordable infrastructure and technical staff. This allows you to fixate your vision on the long-term results of your company. rn3. As most biotech firms already know, just meeting the production needs of the company isn’t the end of the road. Sure, it’s great that a CMO can promise – and even better if they can deliver – a reasonable – or speedy – delivery timetable, but equally as important, if not more so, is the CMO’s ability to ensure quality control and FDA regulatory compliance. Both of these processes can be a huge hurdle in terms of upfront overhead costs, not to mention headaches. By contracting out the work with a single-source provider, you can effectively minimize the technical transfer of your projects and products to circumvent unforeseen costs. This can also potentially allow you to speed your new product(s) to market. rn4. Due to the up-and-coming trend in online marketplaces for biotech, CMOs are easier to locate, test, and do business with than ever before. Finding a CMO that fits your specific R&D needs and unique set of criteria can be a daunting task for any emerging biotech firm – but it shouldn’t have to be. Luckily, online marketplaces like BioMarketplace.com, can help you get going with your search for the CMO that’s right for your firm. With a diverse pool of CMOs, direct communication features, and even side-by-side comparisons, sites like BioMarketplace.com can help you find, communicate with, and decide on the CMO that is right for you, and all without extensive travel and meetings – again, saving your firm valuable dollars.