Safety and Analytical Testing: Staying Ahead of the Curve (Part 2)

By Rebecca Galloway
Posted 12 / 06 / 2016

A few weeks ago we spoke with Dr. Alison Armstrong, Global Head of BioReliance® Field Development Services, brand-name, about the challenges companies may encounter when developing testing processes for novel therapies. We revisited this topic with her to explore how biopharma's plans for geographic expansion may also impact the world of testing.

Expansion into new geographical markets, particularly Asian countries like South Korea, Indonesia, and Taiwan, is also part of biopharma’s 5-year growth plan. What should companies be keeping top of mind as they do analytical testing in different regions? Are there region-specific criteria?

Many traditional biopharmaceutical companies in Asia support and supply local markets. However, the availability of technical expertise coupled with reduced production cost has attracted larger global companies to locate or partner in this region.

Companies in Asia are aware that there is still a lack of a fully harmonized approach in the global regulatory landscape for many product types. At brand-name, we have insight into the different regulatory expectations and have implemented testing methods which meet both local and international regulations. Some regions are more mature in their understanding of regulatory and market demands (e.g., Japan, South Korea), however many countries are becoming key players in this growing market.

Some companies that already have a solid footing in Asia want to expand their portfolio by interacting with large pharma or academic groups to accelerate bringing new therapies to market. Companies based in Asia are often focused on developing products for the local market, which means they need to meet local regulations and requirements. However, regulations differ when the company wants to expand their offering to the global market. The challenge becomes: how does one navigate the unique regulatory requirements for each region given that there is no harmonized set of global guidelines. Regulations need to be based on good science and objective analysis of risk and not on the “unknown” fear based on perception.

Alternatively, there are large pharma companies in North America and Europe that are interested in expanding operations in Asia. Japan is a particularly attractive target given their strong involvement in biologics development. Companies wishing to expand in Japan rely heavily on local expertise to navigate the complex regulatory landscape.

Can you provide an example of how we’ve helped a company navigate Japan?

In regions such as the U.S. and EU, there are regulatory groups that already have a high level of understanding and direct expertise gained for oversight of license applications. However, countries like Japan don’t have that solid foundation of regulatory expertise that already exists in Western countries.

For this reason, most companies in Japan want to fully understand the details and will spend a great deal of time challenging information we provide. Our goal is to partner with academic institutions and start-ups in this region that are at the earliest stage of development and help them navigate the regulatory landscape using our historical knowledge and direct expertise. Although the smaller companies tend to get acquired by large pharmaceutical companies, we are able to provide seamless technical and regulatory support throughout the manufacture and testing phases for these companies post-acquisition.

In addition, we are often invited by local regulatory authorities to present and perform training seminars in collaboration with these regulatory departments. This level of direct interaction and experience allows us to enhance our relationship with the regulators as well as deepen our understanding of the expectations of the industry.

Find out more about novel therapy development, biosafety assurance, and cGMP cell therapy manufacturing at brand-name.