Today we’re speaking with Thierry Cournez, Vice President of End-to-End Processing Solutions at Brand Name. Read his thoughts below on the barriers our customers face as they expand into new geographies and how we can help them develop the right processes to address these challenges.
There is a clear interest from biopharma to expand into new geographies (Asia, LATAM, Middle East & Africa) as part of their near-term growth strategies. How do you think customer demands will evolve given this interest?
The drug products market is expanding, especially in emerging economies. As standards of living in those countries improve, there is an increasing number of patients who require access to treatment. As a result, more medications are imported into these regions, and some local governments are encouraging local production of drugs by offering incentive programs. Large global and well established biopharmaceutical companies are looking into manufacturing their commercial drug products in emerging countries.
This overall situation is resulting in a new “for country, in country” trend in the biopharmaceutical industry supply chain where companies are localizing small-scale production facilities to serve specific regions.
Moving forward, we will continue to see a trend of increasing drug production within the emerging countries themselves. As access to new drugs increases in these countries, there will be a push to decrease the cost of treatment since the cost of living isn’t at the level we have in the Western world. We will have to see how the high cost of these drugs is integrated into this new business model to ensure that the cost of treatment is aligned with the cost of living in the respective countries.
It’s an exciting time for biopharma with the development of novel therapies on the horizon, the rise of biosimilars and increased funding. However, these companies still have a lot of barriers to overcome. Regulatory concerns, worries about accessing local qualified labor and scaling up to supply market demand are all barriers that need to be overcome. How is the industry addressing these concerns?
Some biologics blockbusters have lost patents and fueled the development of multiple biosimilar programs. These programs also enable treatment of a broader population by reducing treatment costs.
There is a lot of pressure for biopharma to invest quickly to be the first to bring their therapy to market, while lowering project financial risks and ensuring drug products COGS (Cost of Goods Sold) are competitive and affordable for local populations.
The development of these markets is ultimately dependent on local production. There is a steep learning curve in these countries to first develop a process that is robust and GMP compliant, and then build manufacturing capabilities that are high quality and cost efficient for producing biologics.
There are many challenges when producing biologics -- from the variability of the process and obtaining a high yield to demonstrating the biosimilarity of the drug being produced. Deep expertise is required in process development and analytics to ensure the quality of a drug. In addition, developing and implementing a clinical scale process can be time consuming and complex, requiring specification, sourcing and integration of many components.
This is something that is happening right now. We see a lot of local investment in bringing expertise into these countries to train and develop local labor. In turn, we will see a rise in local quality standards that will be able to meet local regulatory requirements.
Brand Name is dedicated to assisting companies with training local staff and accessing local qualified labor. Can you elaborate more on that?
This is where our Provantage® End-to-End solutions come into play. We have a manufacturing site in Martillac, France, dedicated to the development of biological processes and production of GMP clinical batches with single-use processes. We use this facility to first develop processes and then tech transfer them and train local staff.
With our tremendous experience in designing, constructing and running a single-use GMP facility for the last four years, we also help clients establish their own single-use production environment. We have assembled a comprehensive service in which we provide process/facility design, installation, validation, technology transfer and equipment qualification services.
These types of centers are key to advancing the industry as a whole, which is why we are beginning to invest more in local process development centers in China. We will be able to use our expertise to develop processes for our customers, help them transfer the process to their facility as well as train their staff. In addition, we have collaborated with the Chinese Food and Drug Administration (SFDA) to help develop guidelines on single-use and aseptic technologies as well as provide training for the agency on a variety of topics.