SmithBio is a global provider of total bioprocessing solutions for, biopharmaceutical, cell therapy, agriculture and biotechnology applications from process design and research to Industrial production. SmithBio's European head office in The Netherlands supervises the quality of design, engineering, and manufacturing operations of SmithBio China (赛思柏欧 Co., Ltd.) to assure compliance with internationally recognized European quality standards and the ISO9001 Quality Management System.
SmithBio is committed to providing its clients confidence of delivery, quality, service, and integrity. We understand that the work we do is ultimately vital to the clients we serve.
Our experience, flexibility, and commitment make the difference.
We support our global clients through a competent team of International professionals, having long term experience in GLP and cGMP design and engineering, project and quality management, product development and process development, integration and validation of cGMP bioprocessing systems and analytical laboratory instruments, as well as in International business. We support today's academic and research laboratories, CRO's, CDMO's and Industrial manufacturing companies with meeting their current and future requirements and objectives.
SmithBio China (赛思柏欧) is the Asia-Pacific center of excellence for facility and process design, engineering, equipment manufacturing and quality validation of well-known brands such as BIOTOP .
SmithBio China is ISO9001:2015 accredited, with manufacturing sites (10,000 ㎡) and QC laboratories located in Huangshan as well as in Suzhou and Shanghai. It's mainland China and Asia-Pacific sales, marketing and technical support offices are located in Beijing, Shanghai, Suzhou, Huangshan and Chengdu.
At SmithBio all the required capabilities and resources are in place to deliver what we promise. Our experienced International team and our closely connected global network of Industry leading technology providers are available to satisfy your research and processing needs and to exceed your expectations.
SmithBio's global partner network includes companies such as ProBioGen, Pall, Siemens, Hamilton, Cercell, Alfa Laval, CEPA, PreSens, TNC Bio, SiBiTech, IlShin Biobase, Virtuvax and more.
SmithBio offers total solutions as well as tailor-made solutions, from analytical research instruments to laboratory scale and industrial scale applications for cell cultivation and fermentation.
SmithBio's total solutions offerings include
- feasibility study and cURS creation
- concept and basic design support
- detailed facility design support to 3rd party contractor
- production process design and engineering support
- project team formation and project management support
- project execution support
SmithBio's tailor-made solutions meet the needs of research, production QC and cell therapy laboratories as well as cGMP manufacturing facilities and address the challenges our clients face during the entire product development cycle
- from laboratory experiment to cGMP production performance qualification (PQ)
- from single system to turn-key bioprocessing solutions.
Our tailor-made solutions especially relate to processing of vaccines, antibodies, recombinant proteins, biosimilars and cell therapy (CAR-T) products, including
- customized design and engineering of cGMP compliant automated bioprocess equipment in accordance with clients URS and ASME BPE, ISA88, GAMP5 and USP 21CFR part 11 guidelines*
- at site installation, validation, documentation, and technical service support of cGMP compliant automated bioprocess equipment
- industry specific regulatory compliance and product certification support, including SOP documentation support
- new process design and development support
- existing process optimization and revitalization support
- vaccine adjuvant technology design, qualification, and testing support
- virus strain qualification support
- GMP cell line qualification and virus production optimization support
*) applying international benchmarks for technology, choice of materials and quality workmanship.
SmithBio's product supply and service support capabilities include
- (OEM) manufacturing of cGMP compliant automated bioprocess equipment in accordance with ASME BPE, ISA88, GAMP5 and USP 21CFR part 11 guidelines*
- (OEM) manufacturing of analytical instruments (proven experience and international installed base)*
- analytical testing and QC testing services
- international support with installation, validation, and training
- international after-sales and technical service support
- on-time delivery of parts and consumables from local warehouse
- serum-free ACF media support
- analytical instruments supply
- cell culture instruments supply.
*) applying international benchmarks for technology, choice of materials and quality workmanship.
SmithBio is actively looking for representation in China of International brand products, services, and technologies for biotechnology and bio-processing applications.
SmithBio is also actively looking to support Chinese suppliers of Life Science products, services, and technologies with International representation of their products.