March 19, 2020 PAP-Q1-20-CL-005
Left to Right: Jevon Hsiao Director/Head of Validation,
Richard E. Bruehl Principal Scientist, Analytical Methods Development,
Ramon Biosca Vice President and General Manager, Industrial Group,
Ian Coad Director, Manufacturing Technical Support,
Chantale Robles Associate Director, Quality Compliance
Christian Mayer Senior Director of Operations
We have such an impressive team here specialized in GMP production of recombinant proteins, and we are investing in new facilities on the Emeryville campus. With this foundation, we have entered into the CDMO space to provide these services to other companies and generate growth for this division. Our new GMP manufacturing building was licensed by the FDA in 2018, and we have completed the transfer of our licensed products into the facility. We also just broke ground on a pilot plant for development, scale–up, and early clinical-stage projects, and to feed into and support our GMP manufacturing facility.
Our breadth and depth of expertise in microbial expression are based on three decades of experience with GMP production and working with regulatory agencies. We are now adding mammalian expression for complex proteins that are not active in microbial systems. Grifols has always been a pioneer, and our pioneering spirit is especially evidenced through how we leverage our strengths to support customers. We are ready and available for these new contract projects, to bring your vision to life.
A primary pillar of the Grifols philosophy since the 1940s, and a keyword throughout the company globally, is innovation. A critical piece of that innovation is the flexibility built into our operations, both in terms of the design of the facilities and the people who work in them. I think that the CMF project has given everyone more experience at working cross-functionally and jumping into new places to provide critical support.
As part of the global Grifols group, including Grifols Engineering, we have considerable flexibility to reassign resources while still maintaining our quality standards. Working with Grifols Engineering gives us a lot more control over design — we have insight into the systems developed by the same team in service at different facilities throughout the world. The engineering team understands the equipment so well because they designed it and built it, and they can share that knowledge with maintenance and the system owners. Having a deep understanding of the equipment coming in is a definite benefit.
From an organizational perspective, we have always looked for ways to streamline validation to be agile and robust, something that can be a major challenge at other organizations.
Our validation strategy is comprehensive and risk based. Our master validation plan is supported by various elemental plans, which govern process/cleaning validation and infrastructure qualification. This plan structure facilitates consistency across validation efforts as well as flexibility to accommodate unique product and process requirements. As we continue to introduce new products and bring on new clients, we are always seeking to continuously improve both the quality of our systems and execution. It’s an ongoing effort for our validation team to always adopt best practices and be agile in introduction of new products.
We have a very diverse organization with experience in many areas within process development and manufacturing. In our CDMO business, we rely on this diversity and experience to pull in the skills to work on new projects. This is not an organization that has simply been producing a single product for the last 15 years — it’s an experienced team of people that produces 21 different products at any given time. We have the technical expertise, equipment, utilities, facility, and capital necessary to help others bring new products to the market, regardless of the customer or the process. Our skillset is complemented by an efficient, flexible workspace that allows us to process and changeover quickly to meet the needs of current and future products.
A challenge in analytical method development is to innovate solutions to technological limitations in standard test methods and keep pace with testing requirements for new molecules and robust product development. Our method development group has a legacy of analytical development beginning with Chiron, transitioning through Novartis, and now flourishing with Grifols where we support a large suite of test methods optimized for an array of recombinant proteins. Since Grifols has taken charge of the Emeryville site, we have successfully standardized internal operations to increase efficiency, add value, and reduce redundancy. We thoroughly reviewed our legacy tests and method validations for effective applications and lessons learned, and consulted with subject matter experts to inform our current approaches.
Updating our protocols to stay current with state-of-the-art technology and test methods is critical to our success in commercial development and our ability to successfully partner with others. If a customer has a specific bioanalytical requirement, we likely already have a method in our repertoire. If we don’t, we have the flexibility to adapt existing methods or develop new ones.
The value of culture in quality assurance and control programs is inherently difficult to measure, but it is even more important than technology and tools. Our quality department has a good cultural environment marked by an experienced staff that’s encouraged to innovate and is unencumbered by red tape. Over 20 percent of the Grifols quality department have worked here more than 20 years. We attribute that longevity to creating a flexible work environment where efficiency-enabling innovation is rewarded, not stifled by the debilitating “this is how we’ve always done it” excuse. This, combined with newer employees with past experience from other companies and industries, provides us a broad knowledge of quality culture and application allowing us to bring the best programs to our customers.
There’s no better way to truly get the pulse of an organization than engaging with people across departments and examining the culture and unifying vision from a plurality of voices. All of the experts at Grifols Recombinant Protein CDMO emphasize the legacies of quality and innovation at the Emeryville site and across Grifols that provide the organization’s foundation, but are particularly inspired by the current change of focus. This is an experienced team that is agile and flexible and excited by this opportunity — through a creative, collaborative, and interdisciplinary approach — to apply the knowledge and skills honed over decades of precise manufacturing, analytics, and validation to support customers with new and complex proteins as a Contract Development and Manufacturing Organization.
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.