The biologic boom over the last several years has not only reshaped the industry, but is also creating exciting opportunities for both large and small companies. However, despite the renewed hope these innovative therapies offer to a wide range of patient populations, biologics present a number of challenges due to the complexities involved in their development and manufacture. This is particularly true in late-phase drug development, which is often the lengthiest and most cost-intensive stage of bringing a new product to market. Companies without the capabilities in-house to overcome the obstacles involved in the launch of a biologic will need to partner with a CDMO that can help them avoid costly setbacks. However, this is possible only if their partner can execute a cross-functional approach that successfully prepares their product for commercialization.
In a recent webinar, Dr. Claudia Müller, head of formulation development; Dr. Heiko Nalenz, head of process development; and Dr. Roman Mathaes, head of pharmaceutical services, at Lonza Drug Product Services outlined the complex path to a successful product launch, which requires a holistic development strategy driven by a well-defined target product profile. This strategy helps reduce risks while keeping the patient and final market presentation in mind, as they remain a critical factor in successful late-phase development of biologics. In addition, these experts covered key challenges of developing drug-device combination products.