Athersys Partnering With MedCision on High-Volume ThawSTAR Cell Thawing Systems for Use in Clinical Trials
Companies collaborating on 6 mL AT-Closed Vial and a larger-scale cell thawing solution
newsWire 기자입력2017-05-08 15:32:05
(SAN RAFAEL, Calif.=뉴스와이어) MedCision, LLC., the world leader in the automation of cell thawing, and Athersys, Inc., a clinical-stage biotechnology company developing proprietary cell therapies, have formed a strategic partnership to include the use of the ThawSTAR® Cell Thawing System in Athersys’ clinical trials.
In the first stage of the partnership, Athersys adopted MedCision’s ThawSTAR AT6 Transport and Thawing System for 6 mL AT-Closed Vial® (Aseptic Technologies S.A.) to de-risk the cell thawing process and optimize cell efficacy in their Phase 2 trial using MultiStem® cell therapy to treat subjects with Non-ST Elevation Acute Myocardial Infarction (NSTEMI).
“The use of the ThawSTAR Cell Thawing System allows us to remove variability and subjectivity associated with traditional methods,” stated Gil Van Bokkelen, Chairman and CEO of Athersys. “Together, our companies plan to implement a novel cell thawing solution for use in future trials, including automated thawing of larger-volume vials for indications where IV delivery is appropriate.”
Large-volume cell thawing is particularly challenging because considerations must be given to osmotic imbalances, thermal gradients and varying intra-vessel phase states. An industry first, MedCision’s proprietary cell thawing technology is able to overcome these biophysical challenges and ultimately ensure that optimal, post-thaw cell health and efficacy is achieved.
“Thawing is a vital and frequently overlooked step in the cold chain,” said Rolf O. Ehrhardt, MD, Ph.D., MedCision CEO. “The ThawSTAR high-volume system is an automated and reproducible thawing platform that will allow Athersys to improve the overall handling of its cell therapies and further ensure the high quality and integrity of its investigational cell-based product.”
The proprietary ThawSTAR thawing system for 6 mL AT-Closed Vials has been recently launched and utilizes a novel adaptive algorithm specific to each unique cell therapy product. The algorithm operates on an understanding that cell size, volume and choice of cryopreservative affect the thawing rate needed to preserve optimal function in a given cell type. Additionally, the algorithm customizes the thaw for each fill volume, ensuring consistent and reproducible endpoints. Vials can be inserted directly from liquid nitrogen storage (below -150°C) or dry ice/ultra-low freezer storage (-80°C).
For more information about MedCision, please contact Samuel Kent.
About MedCision
MedCision develops automation technologies for vital clinical product handling processes. An industry first, the ThawSTAR Automated Cell Thawing System replaces uncontrolled and highly variable manual methods with a customizable algorithm to thaw each unique cell therapy product to maintain maximum cellular efficacy. MedCision’s global customers include pharmaceutical, medical, stem cell and other GMP facilities where consistent and repeatable outcomes are paramount. For more information please visit www.medcision.com or www.medcision.com/blog/.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170503005387/en/
언론연락처:MedCision Media contact information: Marla Kertzman 209-852-9027 Business development contact: Samuel Kent 415-342-4814
이 뉴스는 기업·기관이 발표한 보도자료 전문입니다.
출처 : MedCision, LLC.
홈페이지 : www.medcision.com
In the first stage of the partnership, Athersys adopted MedCision’s ThawSTAR AT6 Transport and Thawing System for 6 mL AT-Closed Vial® (Aseptic Technologies S.A.) to de-risk the cell thawing process and optimize cell efficacy in their Phase 2 trial using MultiStem® cell therapy to treat subjects with Non-ST Elevation Acute Myocardial Infarction (NSTEMI).
“The use of the ThawSTAR Cell Thawing System allows us to remove variability and subjectivity associated with traditional methods,” stated Gil Van Bokkelen, Chairman and CEO of Athersys. “Together, our companies plan to implement a novel cell thawing solution for use in future trials, including automated thawing of larger-volume vials for indications where IV delivery is appropriate.”
Large-volume cell thawing is particularly challenging because considerations must be given to osmotic imbalances, thermal gradients and varying intra-vessel phase states. An industry first, MedCision’s proprietary cell thawing technology is able to overcome these biophysical challenges and ultimately ensure that optimal, post-thaw cell health and efficacy is achieved.
“Thawing is a vital and frequently overlooked step in the cold chain,” said Rolf O. Ehrhardt, MD, Ph.D., MedCision CEO. “The ThawSTAR high-volume system is an automated and reproducible thawing platform that will allow Athersys to improve the overall handling of its cell therapies and further ensure the high quality and integrity of its investigational cell-based product.”
The proprietary ThawSTAR thawing system for 6 mL AT-Closed Vials has been recently launched and utilizes a novel adaptive algorithm specific to each unique cell therapy product. The algorithm operates on an understanding that cell size, volume and choice of cryopreservative affect the thawing rate needed to preserve optimal function in a given cell type. Additionally, the algorithm customizes the thaw for each fill volume, ensuring consistent and reproducible endpoints. Vials can be inserted directly from liquid nitrogen storage (below -150°C) or dry ice/ultra-low freezer storage (-80°C).
For more information about MedCision, please contact Samuel Kent.
About MedCision
MedCision develops automation technologies for vital clinical product handling processes. An industry first, the ThawSTAR Automated Cell Thawing System replaces uncontrolled and highly variable manual methods with a customizable algorithm to thaw each unique cell therapy product to maintain maximum cellular efficacy. MedCision’s global customers include pharmaceutical, medical, stem cell and other GMP facilities where consistent and repeatable outcomes are paramount. For more information please visit www.medcision.com or www.medcision.com/blog/.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170503005387/en/
언론연락처:MedCision Media contact information: Marla Kertzman 209-852-9027 Business development contact: Samuel Kent 415-342-4814
이 뉴스는 기업·기관이 발표한 보도자료 전문입니다.
출처 : MedCision, LLC.
홈페이지 : www.medcision.com
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