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Immediate scheduling without waiting
Tech-transfer takes 2 months only
Comply with NMPA, FDA, EMA GMP regulations
GenScript Probio is the world's leading CDMO platform, committing to providing global biopharma and biotech companies with end-to-end, one-stop professional services from drug discovery to GMP Biologics manufacturing (including but not limited to antibody production, protein production, etc.).
Our GMP production center follows the internationally leading design concept and is a true "zero-crossover, unidirectional flow" plant, which meets global regulatory requirements. Strict physical isolation measures are adopted in the whole workshop, which ensure production of multiple samples at the same time.
GenScript ProBio now owns 5 independent large-scale cell culture GMP upstream production lines with a total culture volume of 2,600L; and 3 independent downstream purification production lines; the annual production capacity can reach up to 104 batches per year .
The whole process, including solution preparation, cell culture, downstream chromatography and filtration, adopts single-use technology that effectively avoids the risk of cross-contamination.
In addition, the GenScript ProBio technology transfer Team has established a comprehensive and refined technology transfer process and has implemented comprehensive risk control in the technology transfer process, which ensures the smooth transfer of customer projects and successful production.
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GenScript ProBio has established a complete technology transfer SMP, which enables multi-dimentional gap analysis and risk assessment in terms of personnel, equipment, material, method, environment and testing. Successful process transfer can be ensured either from clients or to clients.
Line 1:Cytiva XDR200L×2Cytiva XDR500L×1
Line 2:HyPerforma 200L×2
Line 3:HyPerforma 200L×2HyPerforma 500L×1
Line 1:ÄKTA Ready 10mm×2Mobius single-use filtration skids ×1
Line 2:ÄKTA process 10mm×2Non-disposable filtration skids ×1
The design and construction of ProBio’s cGMP production workshop was carried out in strick compliance with the current regulations and guidelines of China, the US and the European Union. It functions based on the quality system of highest standard and can effectively meet the requirements of global surveillance for biologics production facilities.
ProBio’s quality management system strictly complies with ICH and global GMP regulations which includes 6 major sub-systems