Spotlight On... Boehringer Ingelheim snags second client for its China CMO operation; FDA wants more info on excipient decisions; PhRMA questions 'burden' or quality metrics; and more...

Boehringer Ingelheim's contract manufacturing operation in China has picked up a second client, with an announcement coming just days after announcing its inaugural deal. The German drugmaker last week said it has an agreement to manufacture a monoclonal antibody candidate for Shanghai-based biotech ZAI Lab. This deal comes shortly after Boehringer said it has won its first client with a deal to manufacture immuno-oncology drugs for Beijing-based BeiGene, once it completes construction of a €35 million ($44.9 million) plant it is building in Shanghai. The facility, which the company is using to do contract manufacturing in China, is slated to be operational in Q1 2017 and to have about 65 employees. Release (PDF) | More

> The FDA's Office of Pharmaceutical Quality (OPQ) is requesting that biotech provide more detail about how they selected the excipients they will use in their products and to provide a risk assessment on potential interactions between the excipients and their proteins. Report

> Reliable Drug Pharmacy is voluntarily recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. Notice

> Lobbying group PhRMA is raising questions about the "burden" that the FDA is putting on drugmakers as the agency moves to measuring quality metrics for guiding its facility inspection schedule. Blog Post

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