WuXi Biologics Completes First Routine FDA Inspection, Announces Partnership Plans

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The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

On April 17, 2019, WuXi Biologics, a provider of end-to-end solutions for biologics discovery, development, and manufacturing, announced that its drug substance (DS) and drug product (DP) manufacturing facilities at WuXi city successfully completed a seven-day FDA surveillance inspection by three inspectors for the production of HIV therapy Trogarzo (ibalizumab), the first routine GMP inspection since product approval, according to the company.

The facilities passed FDA’s pre-license inspection in 2017, as well as the European Medicines Agency (EMA) pre-approval inspection in March 2019. According to the company, no issues related to data integrity were found during the three inspections. WuXi Biologics also reports that it is the first Chinese biologics company to be approved by FDA, as well as the first biologics company in China to be approved by EMA.

Manufacturing partnerships

In related news, WuXi Biologics has entered into a long-term strategic partnership with I-Mab Biopharma, a biotech company focused on biologics in immuno-oncology and auto-immune diseases. The companies will join forces on biologics process development and clinical and commercial manufacturing of I-Mab’s pipelines.

Under the terms of the partnership, I-Mab will leverage WuXi Bio’s expertise and capabilities for chemistry, manufacturing, and control (CMC) development of at least five programs and commercial manufacturing of at least one program for , I-Mab’s monoclonal antibody, bispecific antibody, and fusion protein pipelines, representing a significant expansion from the current projects that the two companies are already collaborating on.

“We are excited to expand our three-year partnership to further enable I-Mab to expedite its extensive biologics pipelines across WuXi Biologics’ unparalleled capacity and world-class capabilities,” said Dr. Chris Chen, CEO of WuXi Biologics, in an April 16, 2019 press release.


“The partnership with WuXi Biologics enables our proprietary assets to move ahead more rapidly, as we are continuously and simultaneously advancing our pipeline in China and abroad and have achieved significant development milestones,” said Dr. Zheru Zhang, President of I-Mab, in the press release. “By integrating our CMC experience and product know-how with WuXi Bio’s advanced technology and capabilities, we will be able to expedite our potential first-in-class and best-in-class biologics to the market to satisfy substantial unmet medical needs with high quality and speed.”

Additionally, on April 9, 2019, WuXi Biologics and NBE-Therapeutics (NBE), a privately owned Swiss biotech company developing next-generation antibody-drug conjugate (ADC) products, announced a comprehensive development and manufacturing partnership for NBE’s first ADC lead product NBE-002 (anti-ROR1).

NBE develops next-generation iADC products based on its proprietary technology platforms-SMAC-Technology, used to generate site-specifically conjugated ADCs, and its proprietary highly-potent anthracycline toxin platform-which allow the company to develop highly targeted treatments with long-lasting anti-tumor immunity. NBE-002 is an immune-stimulatory ADC (iADC) treatment against the ROR1 cancer target and is planned to enter into clinical trials in mid 2020 in triple negative breast cancer and other indications.

The partnership will enable NBE to supply its NBE-002 product for clinical trials under investigational new drug applications worldwide. WuXi Biologics’ integrated biologics solution center provides services for antibodies, ADC drug substances, and drug products.

“This collaboration will accelerate the transition of our preclinical iADC development programs to clinical validation, said Dr. Ulf Grawunder, CEO of NBE-Therapeutics, in a company press release. “We look forward to working with WuXi Biologics over the coming years to deliver improved treatment options for global cancer patients.”

Source: WuXi Biologics