Collaboration to Drive, Support, and Grow High-Containment Biologics Manufacturing
January 9, 2017 – CSSi LifeSciences™, a trusted partner from discovery to commercialization for biologics and vaccines, today announced a strategic partnership with Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC), a nonprofit Contract Manufacturing Service Unit owned and operated by Colorado State University. CSSi LifeSciences™ has extensive preclinical, regulatory and clinical expertise, while BioMARC produces biopharmaceutical products for non-clinical, clinical, and commercial use. Together, these two organizations offer unparalleled guidance for companies developing either biologics or vaccines.
“We are very pleased to establish this collaborative partnership with BioMARC,” said Jim Sergi, President, CSSi LifeSciences™. “We recognize the size and complexity of advanced development solutions for the manufacture and regulated release of viral vaccines and biologics, and are excited to provide a single-source solution to complement BioMARC’s internal resources. CSSi LifeSciences™ is committed to providing BioMARC with the integrated services and resources needed to grow its business and expand its offerings further into the market.”
Transforming a new biologic or vaccine entity into a treatment opportunity is a complex, expensive and time-sensitive process. As part of the collaboration, BioMARC and CSSi LifeSciences™ will work together to create an accelerated, cost-effective GMP and clinical development solution. The two companies complement one another, with proven expertise and experience in process development and cGMP manufacturing using validated processes, as well as preclinical, CMC and global regulatory development and clinical operations.
“Our combined capabilities will provide a fully-integrated, one-stop manufacturing solution for the accelerated preclinical, manufacturing and clinical testing of biological therapeutics, novel vaccines and diagnostic products intended for use in humans,” said Raymond Goodrich, PhD, Executive Director, Infectious Disease Research Center, which houses BioMARC on CSU's Foothills campus.
To date, BioMARC has brought a diagnostic parenteral product through clinical trial and commercial production (including PAI inspection), manufactured a virus vaccine for a phase I clinical study, established several master and working cell or virus banks, developed and qualified cell-based and analytical assays for product testing and release, and established a controlled process for manufacturing a vaccine product for preclinical studies in non-human primates bridging to a phase I study in humans.
Dennis Pierro, PhD, director of BioMARC, also welcomed the new collaboration. “The partnership with CSSi LifeSciences™ significantly strengthens our core capabilities and service offerings in the area of product lifecycle management,” he said. “CSSi LifeSciences’™ broad experience and expertise in regulated products means that we can now better help vaccine and biologic developers efficiently move products into the marketplace to the benefit of patients.”
Over the years, CSSi LifeSciences™ has provided vital business and strategic support to “Big” biopharma, as well as incubators, and enabled the development of over 500 drugs, biologics and in-vitro diagnostics.
CSSi LifeSciences™ has a defined process that lets its clients leverage its breadth of integrated services and growth strategies to develop strategic regulatory and clinical pathways to ensure commercial success and maximize shareholder value.
A formal announcement about the newly developed partnership will be made at today’s CSSi LifeSciences™ Partnering Forum 2017, taking place during J.P. Morgan 35th Annual Healthcare Conference week. For more information on CSSi LifeSciences™ and its diversified services, visit www.cssilifesciences.com.
About CSSi LifeSciences™:
CSSi LifeSciences™ ensures a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. CSSi LifeSciences™ enables faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. CSSi LifeSciences™ is headquartered in Baltimore, MD, with additional offices in San Francisco, CA, London, UK, and Hyderabad, India. For more information, visit www.cssilifesciences.com, email email@example.com, or call (888) 279-8388.
About Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC):
BioMARC is a nonprofit Contract Manufacturing Service Unit owned and operated by Colorado State University. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementation of Current Good Manufacturing Practice regulations and scalability issues.
Visit www.biomarc.colostate.edu for more information.
About Colorado State University (CSU):
Founded in 1870 as the Colorado Agricultural College, CSU is now among the nation's leading research universities. Located in Fort Collins, CSU currently enrolls more than 33,000 students, and has more than 1,800 faculty members working in eight colleges.
CSU is recognized as a premier research institution and routinely ranks as one of the top American universities without a medical school in research expenditures. In Fiscal Year 2016, CSU research expenditures totaled $332 million; this was the ninth consecutive year research expenditures at the university have topped $300 million. More information is available at www.colostate.edu.