BTGEN is a biopharmaceutical contract development and manufacturing organization (CDMO) serving clients across the biologics product lifecycle. Its integrated services span project management, process development, technology transfer, scale-up engineering, manufacturing, analytical testing, and regulatory support. Dedicated project managers oversee work from planning through delivery, with real-time project monitoring and a focus on timely deliverables.

For drug substance development and production, BTGEN offers cell-line development, upstream and downstream process development, formulation and analytical method development, and scale-up. Its cGMP drug substance manufacturing capabilities include mammalian cell culture at scales up to 2,500 liters, chromatography, and ultrafiltration and diafiltration, supporting clinical, process performance qualification, and commercial manufacturing. Drug product services include pre-filled syringe filling, secondary packaging, serialization, lot release, and cold-chain shipping.

BTGEN also provides physicochemical, microbial, and cell-based testing, raw-material and release testing, stability programs, and similarity and comparability assessments. Its regulatory services include document support for MFDS in Korea, PMDA in Japan, and MoH in Turkey, alongside GMP approval support.