Personalized doses now can be filled into single- or multi-compartment capsules for GMP manufacturing
WuXi STA, a subsidiary of WuXi AppTec and a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced the partnership with Multiply Labs (based in San Francisco, CA, USA), a robotics company that has developed industry-leading automated manufacturing systems to produce individualized drugs.
The focus of the partnership is to enable the manufacturing of personalized drugs for patients. Within this collaboration, Multiply Labs has deployed a novel robotic system in WuXi STA’s facilities that efficiently produces advanced solid oral dosage forms, including capsules containing personalized dosage strengths of a single API (e.g., for modified release) and capsules containing personalized combinations of multiple APIs and their formulations. This robotic technology targets a broad range of GMP manufacturing applications, including the production of personalized drug products for specific patient groups (e.g., pediatric/geriatric populations and rare disease patients) and the combination of multiple drugs in one single capsule (e.g., for personalized combination therapies).
Personalized dosing applications – from clinical to commercial manufacturing – have traditionally been very challenging and labor-intensive. Truly personalized manufacturing is limited by the inflexibility of traditional manufacturing technologies, which are only able to generate one large batch each time. The WuXi STA – Multiply Labs partnership addresses these challenges through the unique combination of robotic technology and drug product manufacturing expertise.
As part of the partnership, Multiply Labs has completed the deployment of a robotic system in WuXi STA’s drug product manufacturing site in Wuxi city, China. The manufacturing applications of the robotic system focuses on the development and GMP manufacturing of capsules with personalized doses.
This technology can manufacture virtually any type of capsules, and even capsule configurations that are difficult with traditional technologies. The robots have been designed to handle personalized deposition for most common formulations, including powders, powder blends, granules, beads, and minitabs. The system can be preprogrammed to manufacture personalized product batches – for example, different dosage strengths for different patients, different release profiles for better therapeutic effects, dosage form flexibility such as minitabs vs granule, etc., giving customers the enhanced flexibility.In addition to traditional capsules, this robotic system can also manufacture multi-compartment capsules, which are ideal for drug combinations where two or more APIs or formulations need to be compartmentalized.
“WuXi STA is a globally recognized leader in the formulation development and manufacturing, and Multiply Labs is excited to partner with them in bringing our pioneering robotic technology to the market,” said Fred Parietti, Ph.D., Co-founder, and CEO of Multiply Labs. “Our joint teams have collaborated at an unprecedented speed to develop and deploy this unique technology. Our goal is to enable precision medicine to scale and reach all the patients who need it, and this breakthrough partnership is an exciting step forward towards that vision.”
“We believe that automation is the future of pharmaceutical manufacturing,” said Jinling Chen, Ph.D., SVP and Head of Pharmaceutical Development and Manufacturing Services at WuXi STA. “By bringing together Multiply Labs’ novel robotic technology and WuXi STA’s industry-leading drug product development and manufacturing expertise, we can better support customers to accelerate their drug product development by enabling more personalized dosing for clinical studies.”