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New drug product service delivers expedited CTM
Biotech and pharma innovators are facing considerable challenges to find CDMO partners with capacity and capability to quickly develop and deliver high-quality CTM with flexible options+
The number of novel active substance (NAS) clinical trials increased globally by 8% in 2020*, as a consequence, there is a race to reach clinical trials from biotech and pharma innovators who are facing considerable challenges as they struggle to find CDMO partners with capacity and capability to quickly develop and deliver high-quality CTM with flexible options to suit the molecule and patient.
In response, STA Pharmaceutical (WuXi STA) – a subsidiary of WuXi AppTec– aims to address this bottleneck with a recently introduced integrated service package to provide customers with an expedited path to phase I CTM (Clinical Trial Materials) supply. The collateralized service package, called Fast to Clinical Supply (F2CS), combines prototype development, demo batch manufacture, stability testing, analytical method development and validation, GMP clinical trial material manufacturing and release, with packaging and labeling. The F2CS package can deliver Phase I CTM in just 4-8 weeks after receipt of GMP API. If the formulation is not ready, WuXi STA has a team of scientists that can deliver phase-appropriate formulation development for the CTM within 8 weeks. The overall timeline for formulation development and CTM manufacture can be as few as 12 weeks – an industry-leading timeline.
One of the primary advantages of F2CS is that the integrated program enables running parts of the manufacturing and associated regularity requirements in parallel at the same facility, which is a decisive factor in rapidly improving standard development timelines allowing clinical trial material (CTM) to be delivered in such a short time frame.
Flexibility is an additional benefit that comes via the breadth and depth of WuXi STA's formulation platform. Approximately 90% of pipeline drugs today fall into the two low solubility categories of the Biopharmaceutical Classification System (classes II & IV). ** For these compounds, ensuring sufficient exposure in the clinic will require at least one type of technical application from bioavailability enhancement technology such as spray-dried dispersion, hot-melt extrusion, nano-suspension, and softgel and liquid-filled hard capsule or processing options such a wet granulation, roller compacting, and direct compression. The flexible package also allows for a wide variety of dosage forms from API in bottle to injectable dosage forms, and many more.
Another critical advantage of partnering with WuXi STA is their end-to-end CMC service facilities are integrated across API R&D and manufacturing, formulation development, CTM manufacturing, analytical development and validation, packaging & labeling, stability testing, and CMC writing which speeds development by reducing delays in the transfer of materials, easy sharing of knowledge, and close collaboration for scheduling and troubleshooting. WuXi STA’s CMC platform is supported by 1,192 formulation and analytical scientists and 4,036 manufacturing staff which ensures ample capacity at every stage.
Ultimately, this means by using this comprehensive platform, WuXi STA empowers innovators with much greater flexibility and expedites programs through to ‘first-in-human’ (FIH) and beyond quickly, while simultaneously future-proofing much of their development strategy with the optimal dosage form for their drug target. This provides security to both innovators and investors, but will also prevent future formulary delays should the product progress successfully through clinical phases.
** Data Source: American Pharmaceutical Review (2013) Ralph Lipp. The Innovator Pipeline: Bioavailability Challenges and Advanced Oral Drug Delivery Opportunities
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