Connecting the Manufacturing Process to Patient Wellness

Line workers in an aseptic formulation, fill, and finish operation may seem pretty far removed from the clinic, but in reality, contract manufacturing organizations (CMOs) have a tremendous impact on patient wellness. The more CMOs understand this influence, the better able they will be to ensure the needs of their ultimate customers—patients—are fully met.

Over the past year, Baxter BioPharma Solutions has put in place a two-fold campaign to reinforce a patient-centric focus, first, among its own employees and, second, throughout its partnerships with pharmaceutical customers. Our first goal is to help our manufacturing employees understand the higher purpose behind what they do each day, regardless of whether they are moving raw materials from the cooler to the production suites; working in the compounding, mixing, or filling suites; or labeling and inspecting vials before distribution. Using banners, videos, and educational programs, we encourage team members to appreciate how what they do each day may help save a child's life or make someone's golden years brighter.

Kim Thomas

Our pharmaceutical partners have assisted with the effort, coming to our facility to educate our employees about the disease their products treat, the agents' mechanisms of action, and the symptoms patients may experience. This knowledge helps keep the person waiting for treatment on top of the mind and it fosters a sense of pride and motivation to work harder and better. Thus, a patient-centric mindset can influence operational performance, batch-release times, exceptions for batches, and the overall performance of the facility.

Moreover, a patient focus influences the counsel we provide to our pharmaceutical partners on reformulations and enhanced packaging that ensure patient safety and help clinicians comply with regulatory requirements concerning admixture and administration of parenteral products. Packaging considerations also take into account patients who may self-administer medication for a particular disease or condition. Consider, for example, an individual with motor impairment. For that person, medication in a prefilled syringe or autoinjector may help them manage treatment on their own and comply with a chronic-treatment regimen.

Darren Hieber

Of course, considering patients and clinicians is good business. When pharmaceutical companies make it easier for clinicians to comply with regulations, it improves market share. When CMOs help reformulate or repackage a molecule to improve ease of administration, those efforts may extend the commercial lifecycle of the products.

But commerce cannot and should not be the ultimate objective. Producing high-quality therapeutics in a reliable fashion, and ensuring they meet the needs of patients, increases the likelihood that patients will get better, live longer, or manage a chronic disease more easily. If someone's life is better because of a therapeutic, then a day's work in the clinic, at a pharmaceutical company, and in a CMO was filled with purpose.

And, ultimately, that is what makes an organization successful.

Kim Thomas is a senior marketing manager and Darren Hieber is a product manager, both at Baxter BioPharma Solutions, Round Lake, IL, kim_thomas@baxter.comdarren_hieber@baxter.com