With new, state-of-the-art facilities, extensive tech transfer experience and ongoing investments, Grifols provides contract development and manufacturing services for the production of bulk recombinant proteins for use in diagnostics, therapeutics and vaccines.
Protein Manufacturing in a Custom Facility at Grifols
Our new, $80 million Consolidated Manufacturing Facility (CMF) is located in Emeryville, California. Surrounded and supported by complementary functions and facilities on the Grifols campus, CMF was designed, built and validated to extend our three decades of reliable current Good Manufacturing Practice (cGMP) production of recombinant proteins into the future. The flexible, multiproduct design of CMF and the available manufacturing capacity created an opportunity to leverage our technical expertise and Grifols’ commitment to quality to provide contract services to biopharma companies as a recombinant protein Contract Development and Manufacturing Organization (CDMO).
CMF features 25,000 square feet of Good Manufacturing Practice (GMP) production space, including two separate fermentation suites for Escherichia coli and yeast, three purification suites and a bulk fill area. The facility layout, designed and built by Grifols Engineering, allows for future process-fit flexibility, easy segregation and rapid process changeover. Production suites with dedicated air-handling systems are physically isolated to minimize risks of cross-contamination. The facility consolidates all of the functions required to support GMP production of recombinant proteins, including warehousing, utilities and maintenance operations, which helps create efficient communication and cross-functional interactions and fosters a collaborative culture that enhances our agility and responsiveness to new projects.
To integrate and simplify process control, real-time monitoring and data trending, we installed advanced automation systems throughout the facility, including a distributed control system (DCS) and a central data historian. Touch screens are available to operators both inside and outside of each manufacturing suite and provide clear visibility into our manufacturing operations and facilitate on-the-floor troubleshooting and analysis.
Leveraging our Expertise to Support Customer Needs
We are well positioned to provide development and manufacturing services to customers seeking recombinant protein production, including therapeutic biologics and vaccines. The location of our facility — in the heart of the San Francisco Bay Area biotech hub — positions us as a go-to recombinant protein CDMO for the local small and virtual biotech companies that lack internal resources, including access to a modern manufacturing facility.
CMF is staffed by highly experienced individuals with diverse expertise and educational backgrounds who have been rigorously trained to support efficient GMP operations. The CMF teams are supported by complementary functions including R&D, process development, analytical laboratories and in-house regulatory support, allowing us to provide a comprehensive range of the services that smaller biotech customers need to get from gene to the clinic and beyond.
Extensive Tech Transfer Experience
Grifols received approval from the U.S. Food and Drug Administration (FDA) to relocate existing immunodiagnostic manufacturing operations to the new CMF in July 2018. This first submission enabled commercial GMP fermentation, purification and bulk fill operations in the facility. It also allowed for the production of one recombinant Hepatitis C virus (HCV) antigen. At the conclusion of this transition, we will have transferred 21 different products into CMF, six of them licensed by the FDA.
The contemporaneous transfer of multiple products to the facility was a multi-year effort that required a clear strategy and detailed planning. A risk-based matrix approach was developed to define the tech transfer activities necessary to relocate 21 products. During the project execution, we gained valuable knowledge and experience that can be applied to future transfers to and from the facility to ensure efficient and robust tech transfers. Through these efforts, we have realized a capable multi-product facility for recombinant protein production.
Expanding Capabilities via Ongoing Investments
In parallel with the tech transfer of the existing products, we are finalizing the design for a new pilot plant. This space — expected to be operational by the end of 2019 — will be refurbished and custom-designed to support pilot and small-volume clinical and commercial manufacturing of recombinant proteins.
Additionally, we have opened new laboratory space for our research and development teams and purchased new equipment to expand our capabilities in mammalian cell culture. Cell culture capabilities will also be included in the pilot plant and in future CMF plans.
The flexible, multiproduct design of CMF created an opportunity to provide contract services to biopharma companies as a recombinant protein CDMO.
Building on the Grifols Quality Culture
Quality is prioritized across all Grifols businesses and is critical for each product we produce. Our quality management system (QMS) is continuously monitored via monthly key performance indicators, quarterly management reviews and internal audits. Our operations are routinely challenged by audits performed by regulatory agencies and customers, which provides further validation of our regulatory compliance. We leverage the Grifols quality tradition to provide the most reliable quality support for our contract manufacturing customers while maintaining a focus on patients as the most important beneficiaries of our commitment to quality.
Grifols is a global healthcare company founded in Barcelona in 1940, committed to improving the health and well-being of people around the world. We produce essential plasma medicines for patients to treat rare, chronic and, at times, life-threatening conditions. The company provides a comprehensive portfolio of solutions in transfusion medicine and also offers hospitals, pharmacies and healthcare professionals information and services that deliver efficient, expert medical care.
Grifols, with more than 21,000 employees in 30 countries, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry.