October 28, 2019 PAP-Q3-19-CL-014
In an increasingly globalized and interconnected industry, pharmaceutical and biotech companies have opportunities to partner with organizations across the world, taking advantage of widely dispersed resources and leveraging opportunities in different global regions at relevant points across the supply chain.
When choosing a strategic partner to guide a project from early development through clinical and, ultimately, commercial manufacturing, there are a range of critical factors to consider and the optimal balance for a given project often depends on the nature of the project itself. When evaluating a prospective CDMO partner, robust quality systems and demonstrated GMP compliance are critical, along with ensuring that the CDMO possesses the spectrum of capabilities needed to support the project, including contingent services and expertise that may be needed if unforeseen complications arise. Of course, cost is always a major determinant when selecting a CDMO, as is the company’s legacy of completing project milestones on time. In addition, factors such as technical expertise and collaboration, effective communication, and transparency may be more difficult to quantify but can impact the ultimate success of a program.
Grifols is a global healthcare company and has a long history of working with partners across the globe and knows how to overcome the challenges of linguistic and cultural differences – as well as geographic distances – but we also recognize the additional efficiencies that are made possible when communication and collaboration are streamlined.
As a CDMO within a larger healthcare company, Grifols also has experience as a buyer of CDMO services. We understand the importance of transparency and responsiveness and have seen firsthand how long-distance partnerships can create difficulties. Due to time differences, it can take multiple days to coordinate schedules for a call when problems arise. If the process doesn’t produce expected results, sending subject matter experts to the CDMO to determine what is happening can be costly. In addition, some raw materials might not be able to be sourced in the country where the CDMO is located, which can extend the timeline to import the reagents.
Efficient communication is important for overall project success and can be particularly critical during tech transfer and troubleshooting, where discussions may be needed in real time to solve problems effectively. This can be mitigated by having client technical experts on-site, but frequent or extended long-distance travel is not always feasible, especially with other projects or activities that require their attention. Cumulative delays can have a significant impact to a project’s schedule. We anticipate these kinds of challenges when transferring the technology and planning the project timeline to minimize the impact and keep the project on time.
Although working with CDMOs across oceans is increasingly feasible given current telecommunications and other technologies, there are still distinct advantages to working with a local partner. Clients often want to be heavily involved in the tech transfer, and working with a local CDMO facilitates this ongoing, in-person collaboration. The ability to regularly meet face-to-face with clients can significantly minimize risks of miscommunications, particularly during exchanges of critical technical information or at crucial decision points. For one of our customers, the product produced by a distant CDMO was not active, and the parties were not able to determine the cause. The company decided to transfer the product to Grifols as a local CDMO where we could work closely together. Our collaboration resulted in producing an active product, allowing the company to get back on track and move forward with toxicology studies showing the benefits of working locally for complex, difficult projects.
Grifols Recombinant Protein CDMO has three decades of experience in recombinant protein technology and partners with companies interested in developing complex proteins into therapeutics, vaccines or diagnostics. Our state-of-the-art GMP biological manufacturing facility located in the San Francisco Bay Area is well positioned to provide long-term, high-quality, commercial manufacturing of recombinant biologic drug substances to our customers, regardless of their global location. This location, in one of the major U.S. biotech hubs — home to many emerging biotechnology companies lacking extensive internal development and manufacturing resources — provides us with an opportunity to effectively serve a host of local customers.
Grifols is staffed by highly experienced and talented people with diverse expertise and educational backgrounds within the field of biotechnology. Our staff welcomes the opportunity to have face-to-face visits with clients where new ideas can be discussed. With their significant tech transfer expertise and access to the state-of-the-art facilities and equipment within the CMF and new pilot plant, including R&D, process development and analytical laboratories, our scientists can rapidly identify solutions for our CDMO clients.
A current challenge in the market is the limited U.S. biopharma CDMO capacity for both drug substances and drug products. We are committed to providing our client partners with the best CDMO services and are investing in new development and manufacturing capacity. We have recently completed an $80-million consolidated manufacturing facility (CMF) at our Emeryville, California campus that received FDA approval in 2018, where we specialize in recombinant Escherichia coli and yeast development, and GMP production.
We have initiated a project to build cell culture and purification suites for GMP production of recombinant proteins expressed in mammalian cells. This project is led by our internal Grifols Engineering department in our new facility's expansion space. The suites will use disposable technology, including bioreactors up to 1000 L, and is expected to be completed in late 2020.
To support process development and scale-up, we completed new development laboratories in 2016 and are finalizing the design for a new pilot plant that will be located across the street from CMF, in what was previously a GMP manufacturing space. The pilot plant will have suites for microbial and cell culture processes to support process development and clinical manufacturing and is expected to be operational in 2020.
These investments expand our capabilities and enable Grifols to grow to meet the needs of current and future customers. The expansion space within CMF provides considerable flexibility to our operations and creates an opportunity for strategic growth to support client needs. Grifols is committed to providing opportunities where we align our goals with those of our clients and grow together.
Kim Berger is the Director of Business Development for the recombinant protein manufacturing business at Grifols with over 30 years of experience in biotech. Before joining Grifols she managed the license agreement portfolio for Novartis, where she provided business analysis for the negotiation strategy of patent infringement litigation and key supply contracts. She was also a member of the Chiron scientific team that “walked the genome” of the NANB/Hepatitis C virus and expressed HCV recombinant antigens in various expression systems. Kim holds a B.S. in genetics from the University of California, Berkeley.