BioLife Solutions Biopreservation Tools For Cells,Tissues,and Organs Our cGMP manufacturing facility has been qualified according to ISO 14644, Clean Rooms and Associated Controlled Environments as called out in Volume 4, EU GMP Guidelines, Annex 1: Manufacture of Sterile Medicinal Products, with re-qualification of the facility every six months. The facility was designed based upon the output of risk analysis as per ISO 14971, Application of Risk Management to Medical Devices. Our Quality Management System is certified to ISO 13485:2003, Quality Management Systems – Requirements for Regulatory Purposes. Regularly scheduled surveillance audits by our certifying authority ensure continued adherence to this standard. Under the standard, we must demonstrate not only the dedication of senior management to cGMP standards, but also our commitment to provide quality product using the best available materials and methods. Since the commencement of operations of our manufacturing facility in the second quarter of 2009, we have successfully passed numerous audits by current and prospective distribution partners and pharmaceutical, regenerative medicine, and contract manufacturing customers. Customer feedback is a vital part of our continuous quality improvement process. Our Case Management System is designed to quickly respond to customer requests and track trends to improve processes and provide input to corrective and preventive actions. We combine this valuable input with our own internal audit findings to continually improve our quality environment. To assist customers with their regulatory marketing applications, Master Files for BioLife products are on file with the FDA. To request a cross reference to our Master Files, please complete our convenient request form.
OriGen CP-70 CryoPur-DMSO 细胞冻存液 二甲基亚砜 进口USP级 CE认证 CP70￥1
Lifeline LL-0002 VascuLife EnGS Complete Kit 人内皮细胞培养基套装￥3,254
Anti-Human CD4 PerCP-Cyanine5.5 人CD4抗体￥4,188
Corning 88-571-kit Natural Killer Cell Serum-free Culture Kit II NK细胞活化扩增培养基套装￥0
Cellartis Y50200 MSC Xeno-Free Culture Medium 人间充质干细胞培养基，无外源无需包被￥1
Origen CS250 Freezing Bags vol-max 30-70mL 冻存袋 细胞治疗用药包材￥1