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140,000-square-foot facility will create more than 200 highly specialized manufacturing jobs to support KBI’s commercialization pipeline
KBI Biopharma Expands US Operations with New $150 Million Commercial Manufacturing Facility Based in RTP, North Carolina
Topics: Corporate Bioprocess
JSR Life Sciences Expands its European Gene-to-GMP Biologics Manufacturing Facilities for Selexis and KBI Biopharma in Geneva, Switzerland
SUNNYVALE, California, October 20, 2020 – JSR Life Sciences, LLC today announced that it is increasing its European footprint with a newly expanded, state-of-the-art facility that will co-locate primary European operations for its affiliate companies KBI Biopharma and Selexis SA. The two companies combined will occupy 8,700 square meters in the Stellar 32 campus within Geneva’s ZIPLO (Industrial Zone Plan-les-Ouates). KBI Biopharma’s expanded facility will enable the Company to offer clinical cGMP biologics bulk drug substance manufacturing for European clients. Selexis’ new workspaces will allow the Company to meet the increasing demand for its highly specialized mammalian cell line development technologies and services. Together, the companies anticipate creating more than 250 new highly technical jobs in the new facilities.
Topics: Corporate
Crown Bioscience Invests in Process Excellence with the Appointment of New Vice President of Global Quality
San Diego, Calif - October 8, 2020 - Crown Bioscience today announces the appointment of Pam Shang as vice president for global quality. Mrs. Shang will be instrumental in further enhancing global quality across the company, leveraging her deep expertise in implementing quality systems for pharma and biotechnology clients including in GLP, GMP and other regulated environments.
Topics: Corporate
Igyxos and Selexis Enter Service Agreement to Advance Igyxos’ First-In-Class Monoclonal Antibody for the Treatment of Human Infertility
Geneva, Switzerland, and Nouzilly, France - September 2, 2020 - Selexis SA and Igyxos announced today that they have entered into a service agreement to develop Igyxos’ first-in-class monoclonal antibody (mAb) drug candidate for the treatment of human infertility. Under the agreement, Igyxos will utilize Selexis’ proprietary SUREtechnology Platform™ to rapidly develop the research cell banks (RCBs) necessary to advance the program to human trials.
Globally, infertility affects approximately 100 million women and men.[1],[2] In many cases, infertility is related to disorder in gonadotropins, which are hormones responsible for regulating the reproductive cycle. Therapeutic gonadotropins to treat infertility have been the standard of care since the 1960s. By developing a first-in-class mAb that boosts the bioactivity of endogenous and exogenous gonadotropins, Igyxos aims to significantly improve the therapeutic management of men and women suffering from infertility.
“Selexis is thrilled to play a part in Igyxos’ novel therapeutic approach to male and female infertility with an effective treatment that may overcome the long-standing challenges of current methods of addressing the issue,” said Yemi Onakunle, PhD, MBA, Selexis chief business officer. “As experts in cell line development, we are able to quickly and cost-effectively deliver the high-expressing, stable and production-ready research cell banks necessary to help Igyxos reach the clinic faster and gain a competitive edge. We look forward to embarking upon this exciting collaboration.”
Current infertility management remains unsatisfactory with low success rates (only 50% of treated couples have a child after four cycles of hormonal treatments on average), expensive and cumbersome medical treatment protocols with gonadotropins (several injections per week for up to 2 years in men) and low compliance (30% of patients stop during treatment).
“30 million men and 70 million women suffer from infertility worldwide, yet the prospect of a successful outcome remains limited due to a treatment landscape plagued by low success rates, challenging medical treatment protocols and low compliance,” said Pierre-Henry Longeray, CEO at Igyxos. “At Igyxos, we are working tirelessly to bring a new and long-overdue therapeutic option to address this important issue. With Selexis’ track record of success and innovative technologies, we’re excited to leverage their expertise for the advancement of our important drug development program.”
Selexis’ modular SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the biologics development continuum, spanning discovery to commercialization.
About Selexis SA
Selexis SA, a JSR Life Sciences Company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 130 drug products in clinical development and the manufacture of seven commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. More information is available at www.selexis.com.
About Igyxos
Igyxos’ mission is to develop new and innovative medical and pharmaceutical technologies in the field of human fertility. Igyxos is involved in all phases of development, from the discovery of promising targets to the identification of potential active compounds such as antibodies. The success of its €7.5 million Series A funding led by Bpifrance, through the FABS funds, alongside with Go Capital Amorçage II and Loire Valley Invest Funds managed by Go Capital and the Emergence Innovation II Fund managed by Sofimac Innovation, will allow Igyxos to develop its lead compound and reach clinical proof of concept. www.igyxos.com
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FOR MORE INFORMATION
– Web www.selexis.com
– LinkedIn www.linkedin.com/company/selexis-sa
– Twitter www.twitter.com/SelexisSA
– Facebook www.facebook.com/SelexisSA
Media Inquiries for Selexis
Mike Beyer
Sam Brown Inc.
+1 312-961-2502
mikebeyer@sambrown.com
Company Inquiries for Selexis
Robert Meister
Head, Corporate Communications
+1 602-953-1716
robert.meister@selexis.com
Company Inquiries for Igyxos
Pierre-Henry Longeray
CEO
+ 33 6 64 28 81 31 (mobile)
+ 33 2 47 42 76 32 (tel)
pierre-henry.longeray@igyxos.com
[1] Boivin J, Bunting L, Collins JA, Nygren KG (2007) International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod 22: 1506–1512.
[2] Agarwal A, Mulgund A, Hamada A, Chyatte MR (2015) A unique view on male infertility around the globe. Reprod Biol Endocrinol 13: 37.
Topics: Corporate
Crown Bio Signals Increased Investment in Digital Transformation with Appointment of New COO
San Diego, Calif - August, 6 2020 - Crown Bioscience today announces the appointment of John Gu as chief operations officer. Mr. Gu will provide leadership in promoting excellence across CrownBio’s global operations, leveraging his deep expertise in digitalization to drive productivity.
Topics: Corporate
New NAFLD/NASH Preclinical Model Data to be Presented at ADA 2020
San Diego, Calif – June 9, 2020 — Crown Bioscience today announced the presentation of new, proprietary NAFLD/NASH preclinical model development data. The data will be available at the American Diabetes Association (ADA) 80th Scientific Sessions, as well as CrownBio’s own complementary virtual event.
Topics: RR & IVD
MBL has concluded the license agreement regarding fully human monoclonal antibodies for four (4) infectious diseases.
NAGOYA, Japan - May 11, 2020 - Medical and Biological Laboratories Co., Ltd. (MBL), a JSR Life Sciences company, announces today that MBL has concluded the license agreement with China National Biotec Group Co., Ltd. (CNBG) of a subsidiary of China National Pharmaceutical Group Corporation (SINOPHARM) to comprehensively license fully human monoclonal antibodies generated by MBL for four (4) infectious diseases treatment. Under this license agreement, MBL confirms the development plan implemented by CNBG and its progress, and receives a license fee including running royalties as consideration for this license. CNBG
acquires the exclusive license to develop, manufacture, and sell those antibodies and to use related technical know-hows in China and the other Asian regions (excluding Japan), and begin development in China.
The fully human monoclonal antibodies were generated by using MBL’s basic technology of the
SPYMEG* or the phage display technology. The antibodies are expected to help in treating and
preventing pandemic infections including Influenza because of their broadly neutralizing activity.
MBL Launches New ELISA-based Companion Diagnostic Kit for Spinal Muscular Atrophy
NAGOYA, Japan - May 8, 2020 - Medical and Biological Laboratories Co., Ltd. (MBL), a JSR Life Sciences company, announced today that it has launched an in vitro diagnostic kit for the genetic disease Spinal Muscular Atrophy (SMA). The MEBCDX AAV9 test kit, which was licensed from Quest Diagnostics, was approved on April 27 by the Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic (CDx) kit for the SMA gene therapy ZolgensmaTM (onasemnogene abeparvovec-xioi) launched by Novartis International AG. The test kit will enable laboratory testing through LSI Medience Corporation starting today.
Topics: RR & IVD
CrownBio Announces C-Suite Leadership Changes
San Diego, CA - April 14, 2020 - Crown Bioscience has announced the appointment of Jean-Pierre Wery, PhD as executive chairman of the board effective immediately. Dr. Wery will also serve as chief technology officer (CTO) for JSR Life Sciences, LLC.
Topics: Corporate
Medical & Biological Laboratories Co., Ltd. launches real time PCR-based assay kit products for SARS-CoV-2
NAGOYA, Japan - March 23, 2020 - Medical and Biological Laboratories Co., Ltd. (MBL), a JSR Life Sciences company, announced today that its subsidiary company, G&G Science Co., Ltd., has successfully completed development of a real-time PCR assay kit for “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The kit was evaluated with clinical samples provided by the National Institute of Infectious Diseases (NIID). NIID and the Japan Ministry of Health, Labour and Welfare (MHLW) today published that the results of testing with the kit corresponded 100 percent to those of the current NIID system on both positive and negative agreement rates. Therefore, starting immediately, the kit can be used not only for emergency testing being executed under the Infectious Diseases Control Law of Japan, but also for the clinical testing for the coverage of public medical insurance.
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