WuXi Biologics will further expand an antibody-drug conjugate (ADC) facility in China on the expectation of its clients’ projects moving to commercial production.
In June 2018, WuXi Biologics announced plans to construct a $20 million (€17.6 million), 6,000 square meter facility for protein conjugates, including ADCs, set to be operational later this year.
A year on, and the Chinese contract development and manufacturing organization (CDMO) has said it is further expanding the site in Wuxi city, China adding cGMP commercial manufacturing for ADCs drug substance and drug product.
Chris Chen, CEO, told this publication the need for more capabilities is “due to expected growth in ADC-based therapeutics and in the company’s client base developing ADCs.”
The CDMO has more than 20 ADC development projects underway, he continued, adding: “We have provided full CMC services for 11 IND filings for bioconjugate products in just the last few years and another four in 2018.
“We expect 2-3 of these will be commercial products hence the investment.”
He refused to disclose how much of an investment this expansion represents.
WuXi STA and Biologics
For ADCs, WuXi Biologics’ site is part of WuXi Apptec’s ADC ONE-stop service offering, which also involves capabilities from sister company STA.
“STA focus on the payload / payload-linker development and manufacturing,” Chen told us. “We take care of everything else, including MAb, conjugation, drug product and testing. We integrate our services with STA so that clients can expect seamless transition.”
STA has a cGMP high potency manufacturing kilo lab for handling ADC payloads – highly potent active pharmaceutical ingredients (HPAPIs) – in Jinshan, located around 60 km from Shanghai. The facility offers containment down to an OEL limit of 0.05 μg/m³ and linker production capabilities.
Another site in Suzhou – about 80 km from Shanghai – gives clients toxicology and biosafety testing for ADCs.