Altruist Biologics Suzhou Facility Achieves First EMA GMP Certification
- Altruist Biologics' Suzhou commercial manufacturing facility passed EMA GMP inspection with zero critical findings, supporting an EU marketing authorization for a biologics client.
- The 60,000-liter antibody facility underwent comprehensive assessment of quality systems, data integrity, and operational performance across the full manufacturing lifecycle.
- Altruist now operates 140,000 liters of CDMO capacity across Suzhou and Hangzhou sites, with planned expansion to 232,000 liters by mid-2027.
Operational Impact
Altruist's Suzhou EMA certification removes a regulatory barrier for EU-bound biologics programs and signals readiness for commercial-scale antibody and ADC manufacturing in APAC, supporting clients navigating multi-region technology transfer.
Source: PharmaSource RSS
SK pharmteco Launches Catalyst Kit for Continuous API Manufacturing
- SK pharmteco introduced a three-stage Catalyst Kit program to guide clients from catalyst screening through commercial-scale continuous fixed-bed reactor (FBR) development for APIs, intermediates, and registered starting materials.
- The program provides 12 catalyst samples in stage one, process optimization support in stage two, and GMP scale-up from kilo through multi-ton production in stage three.
- Continuous catalytic flow processing offers potential benefits including lower catalyst consumption, reduced solvent waste, longer catalyst life, and predictable scale-up for hydrogenation and high-pressure reactions.
Operational Impact
CDMO directors evaluating continuous manufacturing capabilities can now access SK pharmteco's catalyst screening and optimization services as a structured entry point, reducing development risk for hydrogenation and high-pressure catalytic processes destined for GMP scale-up.
Source: PharmaSource RSS