Beyond the initial discovery
In the world of biopharma, there’s so much talk about molecules, chemical reactions and medicine. But what can go unseen is a lot of the heavy lifting that goes beyond initial discovery, that chemical breakthrough.
Creating consistency and efficiency
Calum Park, Ph.D., understands the challenge of staying ahead every day. AbbVie’s vice president of science and technology leads teams that support various stages of a product’s life cycle.
Early on, Park’s team gets a medicine ready for commercialization right before product launch when patients will actually use it. Once the product is launched, Park’s team collaborates with suppliers and internal manufacturing and quality teams so they can ramp up production to serve more patients.
“My teams determine what technology is needed to create and recreate specific chemical and biological processes at our various facilities,” Park describes. “We’ve seen growing numbers of patients for several diseases, and delivering efficiency without sacrificing efficacy is critical to making an impact on patient health.”
Park’s teams support the small molecule and biological processes globally – from the U.S. to Europe and Asia. That means making the same product and quality standards, in some cases greater than 10 years post-development, in facilities thousands of miles away from the original lab and having scaled up the production many times since clinical trials.
“The challenge is to take that process from the original facility and producing the right consistency with each dosage,” Park describes. “We’re doing this with different equipment and raw materials from different vendors.”
Efficiency and consistency are critical components of Park’s world.
“If we detect a trend in our process parameters, for example an impurity at any level, at any point in the production process, we will conduct a thorough investigation,” says Park. “We will identify the source and work with our suppliers and even their suppliers, to find a solution.”
Park’s team will not only correct according to the results of the investigation, but also commission back-up suppliers to help ensure a consistent supply of the medicine.