What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? Grifols’ senior business development manager, Marga Viñes, shares her thoughts with Contract Pharma.

Implementation of automated manufacturing solutions
The increasing implementation of automated manufacturing solutions that leverage robotic technologies is one way that many parenteral drug producers are addressing the complexities they face. Automated systems significantly reduce human interactions with the product and process, thus reducing the risk of contamination and are typically more efficient.

Robots can be programmed to perform the same motion, the same way every time—something that is not possible for humans to accomplish. They also enable the collection of large quantities of data that can be analyzed and used to make process improvements that lead to even greater productivity. Overall, automated processes are robust and efficient and lead to more consistent and higher-quality products.

Focus on quality culture and continuous improvement in manufacturing
In the complex environment of sterile parenteral product manufacturing, a culture of quality and effective quality systems are essential for success. An appropriate quality culture includes a commitment to continuous improvement and an emphasis on designing quality into parenteral manufacturing processes from the start. The use of a quality-by-design (QbD) approach and compliance with requirements for parametric release are two key components of a successful and effective quality program.

Manufacturing processes must be ultra‐efficient while still maintaining the highest level of product quality and safety Grifols has taken on this challenge with an ongoing continuous improvement program that includes everyone involved in the production of our parenteral and blood plasma products, from process design engineers to operators. We have focused on replacing inefficient manual operations that create opportunities for human error with highly automated, multifaceted processes that dramatically boost both quality and productivity.

CMOs with focused manufacturing capabilities
Growth in the pharmaceutical industry is no longer exclusively driven by large pharmaceutical companies. The switch in the marketplace from a focus on blockbuster drugs to an emphasis on therapies that treat orphan and rare diseases has led to the rise of small and emerging pharma companies founded to advance novel medicines for specialized patient populations. These innovators require the support of contract service providers that recognize their unique requirements. Recent successes in the development of orphan drugs coupled with productivity challenges in the classic pharma R&D model for indications with a higher prevalence have resulted in several major pharmaceutical companies establishing business units focused on rare diseases. Sponsor firms developing orphan drugs as parenteral products should only work with CDMOs that have the necessary expertise to produce these complex products and those that are committed to conducting extensive risk assessments before beginning any new project.