Product development: the product development (pd) division leads non-clinical, formulation, manufacturing, chemistry manufacturing and controls (cmc), analytical, and material planning and supply activities for ipm's products. This division is responsible for product supply and associated activities (including product manufacturing, packaging, labeling, distribution, and stability) and the post-use testing of dapivirine rings to support adherence assessments during clinical trials. In 2021, pd's efforts included conducting cmc activities to address feedback received from regulatory agencies, including the questions received from the ema as part of the review process of the monthly dapivirine ring regulatory dossier and as a part of the post-authorization commitments to the ema. Following the positive scientific opinion from the ema for the dvr, the pd team continued efforts related to commercial manufacturing of the dvr. This included completing capacity planning with critical vendors such as ipm's dvr product manufacturing partner, ipm's dapivirine drug substance manufacturing partners, and ipm's silicone manufacturing partner. Additionally, ipm supported the completion of manufacturing scale-up (1x to 5x) process validation. The 5x process validation was completed in 2022 and will be used as the dvr manufacturing scale going forward. Further, the pd team continued developing the three-month dapivirine ring and the dapivirine-contraceptive ring.

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