The unforeseen and drastic effects the COVID-19 pandemic has had on the industry have led to unanticipated challenges, including stricter international shipping regulations, travel restrictions, local lockdowns and more. However, industry leaders are still here to provide support and solutions to move projects forward and ensure novel lifesaving pharmaceuticals continue to be available on the market. One way to offset potential delays due to COVID-19 is to consider completing your GLP testing in China.
For many, it might be intimidating to complete testing abroad if you’re not familiar with the process and requirements of testing in China. However, it’s truly not as different as you might expect and even has competitive benefits to testing in the U.S. – especially with the challenges posed by COVID-19. Understanding what completing GLP testing in China looks like can help you set expectations and feel confident in how to get the most out of the process.
Testing Capabilities & Offerings
Once early discovery is completed in China, keeping your molecule in the country for GLP testing can help keep your project on track. Many labs have a full breadth of offerings, with capabilities including, but not limited to:
- Discovery studies
- IND-enabling studies
- NDA-enabling/post-market studies
- Analytical chemistry
- Bioanalysis; TK modeling
Take advantage of fully functional toxicology facilities, such as Wuxi AppTec, which offer the opportunity to complete testing without the stress of shipping molecules stateside. This option also mitigates any risk of lab capacity or closure complications hindering forward progress.
The key to success in any relationship is communication, and this is true of your relationship with your testing partner. Clear communication is essential from the early stages of vendor selection to the conduction of the study and, ultimately, to the issuance of the final reports. Fortunately, even during the pandemic, you can audit your testing partners to ensure that they are going to meet your needs and offer effective data share platforms and technology to support ongoing communication.
During the study, the data can be easily shared through secure links and share drives. Additionally, WuXi AppTec also offers access to the study data through a secure portal, which eases any strain due to time differences. Virtual access to results allows you to closely monitor the study, even from the other side of the world. Of course, nothing can replace face-to-face communication, and live study updates are routinely provided as often as needed, via video conference tools, to have open and frank discussions on the study progress.
Maintaining Organization & Efficiency
If your testing program crosses divisions or business units (BUs), ensure your selected lab takes the necessary measures to manage timelines effectively. At WuXi AppTec, we appoint a program manager to assist with scheduling and planning. The program manager initiates the process by collecting your necessary information, including test material availability, any analytical methods currently in place and the submission plan. Then, they disseminate the information across the respective groups. The guidance of a program manager ensures the team is on the same page and aligned with your goals and needs.
Our primary focus is on your submission plan as it aids in determining program design. If you are planning submissions for multiple regulatory bodies, we can even design a plan to meet all the requirements, saving testing materials and time. Despite being abroad, our program managers facilitate the timely delivery of quality projects and will proactively look to offset any potential delays down the line. Additionally, all communication is done in English to ensure accessibility and clear testing expectations, supported by meeting minutes provided by WuXi AppTec for reference.
Save on Costs
For molecules that cross multiple BUs, continuing with GLP testing in China after early discovery could also come with options to bundle costs. Additionally, keeping the material and data within one company during testing streamlines the chemistry process, manufacturing and control (CMC) as well as preclinical services. Not to mention, it saves you from the time and stress of moving test materials around between multiple vendors. Multi-track studies make internal coordination easier and more efficient by simplifying the integration of data and dossier writing. It also ensures high-quality data from regulatory and technical management of the program.
It’s essential to complete GLP testing with a facility equipped with extensive capabilities and a trustworthy, seasoned team. Keeping your molecule in China after completing early discovery studies can satisfy these needs and more. Despite the challenges associated with COVID-19, WuXi AppTec’s China facility is operational and has ample capacity to take on your GLP testing. To learn more about keeping your molecule in China for GLP testing , contact your business development representative, or let us know by filing out the form below and we will be happy to help you.
WuXi AppTec provides a portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients.