바이오의약품 개발 및 생산
경험과 전문성을 기반으로 한 CDMO, CRO 서비
글로벌 의약품 생산시설 네트워크를 활용한 당사의 CDMO(의약품위탁개발생산) 서비스와 CRO(임상수탁) 서비스로 연구부터 상업화까지 원활하게 이어지는 개발 과정을 경험하세요. Thermo Fisher Scientific은 30년 이상의 공정 개발 경험을 보유하고 있으며, 240개 이상의 바이오의약품 개발 프로그램을 수행해 왔습니다. 세포주 개발, 임상 생산, 상업 생산에 대한 전문성을 바탕으로 고객의 세포주, 배지, 공정을 활용하거나, 당사의 세계적인 수준의 바이오의약품 개발 솔루션을 활용할 수 있도록 지원합니다.
엄격한 품질 관리, 철저한 규제 준수, 첨단 기술, 헌신적인 전문가 팀은 당사 서비스의 견고한 기반입니다. Thermo Fisher의 신뢰할 수 있는 플랫폼과 전문 지식을 활용하여 보다 빠른 상업화를 경험하세요.
14 drugs with approved BLAs
2018-2022년 동안 미국에서 BLA 승인을 받은 14개 약물 개발에 기여했습니다.
60 customers in 14 countries
2018-2022년 동안 14개국 60개 이상의 고객과 바이오 약물 프로젝트를 수행했습니다.
810+ biologics batches
2018-2023년 동안 임상, 상업, 공정 성능 적격성 평가(PPQ) 포함 810개 이상의 생물 의약품 배치를 생산했습니다.
70% of projects for mAb products
단일클론 항체(mAb)가 2018-2022년 새로 진행된 전체 생물의약품 프로젝트의 70%를 차지합니다.
바이오의약품 서비스 및 통합 솔루션
생명을 변화시키는 치료제 개발을 위한 당사의 글로벌 바이오의약품 생산 네트워크에 대해 자세히 알아보세요.
Thermo Fisher Scientific's biologics facility in St. Louis, MO is a center of excellence in single-use bioreactor technology that specializes in mammalian cell development, process development, analytics, and end-to-end cGMP manufacturing services.
Explore our facility in St. Louis, MO
Thermo Fisher Scientific’s site in Brisbane, Australia is a state-of-the-art facility, specializing in clinical and commercial manufacturing services, including clinical cGMP manufacturing.
Explore our facility in Brisbane, Australia
Thermo Fisher Scientific’s site in Groningen, Netherlands specializes in preclinical and commercial cGMP manufacturing and scale-up of mammalian cell culture, recombinant proteins, and monoclonal antibodies.
Explore our site in Groningen, Netherlands
Thermo Fisher Scientific’s facility in Lengnau, Switzerland specializes in highly flexible bioproduction technologies, including single-use bioreactors up to 5,000 L and stainless steel bioreactors up to 12,500 L, providing a pathway from development to large-scale production as your manufacturing needs evolve.
Explore our site in Lengnau, Switzerland
고객의 혁신적인 약물을 현실로 전환하기 위해 끊임없이 노력하는 당사의 전문가팀을 만나보세요.
Elena Gontarz, PhD, St. Louis, Missouri, USA
Holding her PhD in biochemistry with over 10 years of experience in developing biologics for pharma companies, Dr. Gontarz is our resident expert in global analytical and process development, as well as formulation sciences. Currently, Dr. Gontarz is the Head of the Scientific and Technical Affairs team, leading CMC support and biologics programs from Phase I to commercial manufacturing. Meet with Dr. Gontarz to learn more about our analytical method lifecycle development, cell line development, process development, tech transfer, and late phase commercialization.
Palak Patel, St. Louis, Missouri, USA
With over 5 years of experience in early phase biologic development and delivering innovative solutions for pharma companies, Palak is one of our Scientific and Technical Affairs subject matter experts in cell line and cell culture development for biologics. Meet with Palak to uncover how our early phase biologics solutions can help you get your biologic to patients faster.
Otto P.J. Jurrius, Groningen, Netherlands
Holding his master’s degree in biotechnology with over two decades of biopharmaceutical industry experience, Otto is the General Manager at Thermo Fisher Scientific’s biologics manufacturing site in Groningen, Netherlands. Otto leads biologics project management, manufacturing, engineering, and general management across biologics development, as well as clinical and commercial manufacturing. Meet with Otto to learn more about our innovative clinical and commercial manufacturing capabilities.
Erica Byerley, Lengnau, Switzerland
With over 8 years of experience and degrees in both chemical engineering and biological sciences, Erica is our guru in single-use technology, technology transfer, process design, and operational readiness for biologics development through clinical manufacturing. Erica currently leads our global tech transfer engineering team at our brand-new facility in Lengnau, Switzerland. Meet with Erica to learn about our innovative single-use bioreactors or engineering designs that can accelerate your biologics development journey.
Kym Baker, PhD, Brisbane, Australia
Holding her PhD in immuno-vaccine development with over 30 years of experience in developing and manufacturing biologics for pharma companies, Kym has worked on over 400 biologics with 10 through to product commercialization. Currently, Kym leads our award-winning, globally regulatory-approved biologics manufacturing facility in Brisbane, Australia, serving client programs from Phase I to commercial manufacturing. Meet with Kym to learn more about how we can support your products' lifecycle from tech transfer to clinical and late-phase commercialization and manufacturing, or how R&D tax credit and the Clinical Trial Notification (CTN) Scheme in Australia can help accelerate your early phase product to market.