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INSIGHTS

BioDuro-Sundia is proud to highlight the Head of Process R&D Qixuan Lu’s insights on the topic of Process chemistry for IND filing support and welcome you to explore BioDuro-Sundia Process Chemistry Services.

Click here to learn more about BioDuro-Sundia Process R&D Services.

How does process chemistry fit in to the big picture of new drug research and development, particularly at the IND filing stage?

APIs supply is the cornerstone of all research toward IND filing, including formulation studies, quality control, toxicology, and data collection. These must be supported by adequate APIs. Therefore, getting enough APIs effectively, economically and controllably is very important in the course of IND filing.

What are common challenges for process research and development?

In recent years, innovative drug research and development is growing rapidly, and companies pay more attention to the time management of IND projects. From PCC (Preclinical Compound) to IND (Investigational New Drug), the pressure gets put on process chemistry to complete the work under tight timelines.

In some cases, process chemistry related evaluation isn’t considered at the early gram scale, yet after the PCC becomes confirmed, no time is reserved for process chemistry either. When anticipating timeframe and budget, it is essential to optimize the process with timely delivery to meet IND filing requirements in the course of GLP and GMP batch synthesis. With extreme project pressures, for examples, some pharmaceutical routes typically not suitable for scale-up would be directly used for scale-up.

The IND filing guidelines are dynamic and changing. The requirements for process chemistry are not consistent.

How do process chemistry services at BioDuro-Sundia support clients’ IND filing needs?

Our integrated CMC services for IND filing are exceptionally balanced. Case by case, we find the right balance for each customer in terms of quality, efficiency and cost. In fact, BioDuro-Sundia’s support of IND filing through integrated CMC services dates back to the year 2000. We have navigated IND filing guideline changes and know the trends. With years of practical experience and know-how from various projects, we are confident in our pursuit of balance.

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