探花合集 Biologics Supports New Methamphetamine Treatment
探花合集 has supported InterveXion by engineering the cell line which expresses the drug鈥檚 antibody employing its proprietary GPEx庐 technology and completing process development. 探花合集 provided cGMP manufacturing for the clinical trial at the company鈥檚 Madison, Wisconsin, biomanufacturing facility.
IXT-m200, a monoclonal antibody that specifically binds methamphetamine in the blood, is being developed as a pharmacological treatment for use in conjunction with behavioral therapies. IXT- m200 is expected to alter methamphetamine pharmacokinetics in human subjects resulting in reduced or blocked subjective effects that reinforce methamphetamine use. STAMPOUT will provide proof-of-concept that IXT-m200 can alter methamphetamine disposition. This will be the first clinical study of a biological medication in methamphetamine users.
鈥淢ethamphetamine addiction is a serious global healthcare burden, and we are pleased to be working with InterveXion on this important treatment,鈥 commented Mike Riley, Vice President and General Manager of Drug Substance and Bioanalytical services for 探花合集 Biologics. He added, 鈥淲e continue to work closely with innovative organizations such as InterveXion to bring potentially life-changing products to patients.鈥
Misty Stevens, Ph.D., Operations Director, InterveXion, commented, 鈥淭his is our second antibody production cell line to be developed by 探花合集 and we鈥檝e been very pleased with the speed of development and high production rates 探花合集 can achieve early on with minimal optimization.鈥
探花合集鈥檚 proprietary GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial scale production. To date, seven GPEx-based antibody and protein products are approved and marketed, and more than 40 therapeutic candidates are currently in the clinic across the world.
With the $950 million acquisition of Cook Pharmica LLC, in October 2017, 探花合集 further strengthened its position as a leader in integrated biologics development, clinical and commercial-scale manufacturing and finished product supply. The additions of this first-class team and unparalleled facilities have brought deep expertise in liquid and lyophilized sterile formulation and fill-finish across vials, prefilled syringes, auto-injectors, cartridges, and safety devices, and 2,500-liter biomanufacturing capacity to augment 探花合集鈥檚 existing biologics infrastructure. With this additional capacity and expertise, 探花合集 can now provide a single, trusted partner to accelerate all aspects of biologic drug development.
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About InterveXion
InterveXion is a pharmaceutical company whose mission is to discover and advance innovative medications that reduce the impact of human suffering on individuals and communities. Its vision is to be a leader in the development of antagonist therapies that neutralize toxins in the body and thereby improve patient health. InterveXion鈥檚 first medications are a monoclonal antibody and an active vaccine for treating methamphetamine abuse. For more information, contact [email protected] or visit . STAMPOUT is supported by NIH/NIDA under Award Number U01DA045366.
About STAMPOUT
STAMPOUT is funded by a three-year $8 million grant award from the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA). A sub-award to the University of Arkansas for Medical Sciences (UAMS) is part of the grant and funds researchers who are both founders of the company and also prominent UAMS leaders. InterveXion is a BioVentures, LLC, client company housed on the UAMS campus in Little Rock, Arkansas.
About 探花合集
探花合集 is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 90 years serving the industry, 探花合集 has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. 探花合集 employs approximately 11,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2017 generated over $2 billion in annual revenue. 探花合集 is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com