News & Events
June 27, 2018- BioMARC, the Biopharmaceutical Manufacturing and Academic Resource Center, a non-profit biologics contract development and manufacturing organization (CDMO), owned and operated by Colorado State University (CSU), has been awarded a new contract with Boston Children’s Hospital (BCH). BCH is the world’s largest research enterprise based at a pediatric hospital and is affiliated with Harvard Medical School. The contract is for the scale-up and manufacturing process development for an innovative vaccine candidate for Salmonella typhi and Salmonella paratyphi, incorporating the groundbreaking Multiple Antigen Presenting System (MAPS) vaccine platform developed by Dr. Fan Zhang, Instructor of Pediatrics at Harvard Medical School, Dr. Yingjie Lu, Assistant Professor of Pediatrics at Harvard Medical School, and Dr. Richard Malley, Senior Physician in Medicine at Boston Children’s Hospital and Professor of Pediatrics at Harvard Medical School.
Salmonella typhi infection (often called typhoid fever) is a major cause of morbidity and mortality worldwide, and current vaccines are not suitable for young children. Salmonella paratyphi infection has emerged as an important cause of enteric disease in Asia with no available vaccine. Initial pre-clinical studies with the MAPS-based vaccine candidate have demonstrated a potent immune system response. The Bill & Melinda Gates Foundation has funded the Boston Children’s Hospital program to further develop their novel vaccine platform to address this significant global health threat.
BioMARC will manufacture the bulk drug substance, formulate and fill-finish the drug product into vials. Other project aspects include analytical method technical transfer as well as release and stability testing of the finished drug product. The work will be conducted under phase-appropriate conditions and the resulting drug product may be used for pre-clinical toxicology studies, inactivation validation studies, or similar studies which are crucial to the development process for a human vaccine candidate. “This project is a great fit for BioMARC’s expertise,” noted BioMARC Director Dr. John Wyckoff. “When creative scientists perform research that leads to promising drug candidates, at some point they need to transition from an academic laboratory setting into a regulated manufacturing environment and scale-up their processes. This often presents new sets of challenges that need to be addressed. BioMARC’s experienced technical and regulatory team are excited to work on this new vaccine platform and to help get this much needed vaccine further down the development pathway.”
CSU’s BioMARC wins HIV vaccine manufacturing project
March 02, 2018– BioMARC, a non-profit biologics contract development and manufacturing organization (CDMO) owned and operated by Colorado State University (CSU), has won a large new contract with Sumagen Co., Ltd, a Seoul, South Korea based global biotechnology company to scale up their manufacturing process for an innovative new HIV vaccine candidate. The key task of this new contract is to continue development work by bringing the manufacturing process to full scale volume. Tasks already successfully achieved in the previous contracts between Sumagen Co., Ltd and BioMARC are process technical transfer, creation of a working virus bank, stability testing of the working virus bank, process development, and a pilot manufacturing run of the HIV vaccine. Soon work will start on verification and qualification of analytical methods associated with the production, and preparation for a full-scale cGMP manufacturing production run with associated fill/finish of drug product to be used in upcoming human clinical trials. Sumagen Co., Ltd stated, “We are pleased to continue our development program with BioMARC on this important vaccine and we look forward to a productive partnership with the BioMARC team.”
HIV is a disease that has had significant impact on global health for over 3 decades and continues to be an issue today. Since the first cases of HIV were reported in 1981, approximately 1.8 million people in the United States alone have been infected. According to the CDC, HIV disease continues to be a serious health issue for many parts of the world. Worldwide, there were about 1.8 million new cases of HIV in 2016. About 36.7 million people were living with HIV around the world in 2016. An estimated 1 million people died from AIDS-related illnesses in 2016.
“There are very few places with the capabilities and infrastructure to tackle a project of this scientific complexity with such important biosafety considerations,” BioMARC Director John H. Wyckoff III, PhD noted. BioMARC offers the unique combination of full cGMP compliant manufacturing within a high containment environment, suitable to handle large volumes of live virus that require biosafety level 3 (BSL-3) containment. The innovative strategy for this vaccine candidate represents the leading edge of what is occurring in biotechnology research and development today. When a new drug candidate transitions from the research stage into higher volume manufacturing, there are a number of technical and regulatory issues that can arise. This is where BioMARC can apply its expertise to help move vaccine candidates further down the path towards testing and potential approval. “Our whole team has been and continues to be very excited to work on a project with such great potential to address a human health problem of this magnitude,” added Wyckoff.
BioMARC is part of CSU’s Infectious Disease Research Center (IDRC) at the Foothills Campus, where professors and students can work near life science startup companies who rent lab and office space at the Research Innovation Center (RIC) facility. IDRC Executive Director, Professor Raymond Goodrich commented, “This project is a great example of CSU’s continuing commitment to the original land grant mission around research and extension. We serve our communities, state, nation and global healthcare communities by applying scientific expertise and world-class infrastructure to address some of the most important unsolved problems in the field of biotechnology and infectious diseases.”
October 2, 2017- John Wyckoff has been named the new director of the Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) at Colorado State University.
Wyckoff will lead BioMARC, a nonprofit contract manufacturing operation owned and operated by CSU to produce vaccines, therapeutics, diagnostics, and other biopharmaceutical products. In this role, he will oversee operations relating to CSU’s research expertise in translational medicine in the Infectious Disease Research Center and the greater CSU community.
Wyckoff’s new position with BioMARC will allow him to continue to develop strategic partnerships needed to accelerate manufacturing and commercialization of biologic products, from the bench to the bedside.
March 1st 2017– Colorado State University’s vaccine manufacturing facility, BioMARC, is developing a drug to protect U.S. soldiers from a mosquito-borne pathogen that can cause severe illness and death.
“The vaccines we will be producing will be used in clinical trials in humans,” said Dennis Pierro, BioMARC’s previous director and an assistant professor in CSU’s Department of Microbiology, Immunology and Pathology. “BioMARC has experience in this realm, but this is the first time in our support of the Department of Defense that we will make the vaccines for humans.”
CSU is a subcontractor on the vaccine project for Battelle, a research organization that works with the DoD’s Medical Countermeasure Systems Joint Vaccine Acquisition Program. One of the program’s requirements is to develop vaccines to protect soldiers from exposure to aerosolized viruses.
To help with this mission, BioMARC uses a state-of-the-art vaccine system called a Viral Replicon Particle that researchers believe results in improved vaccine efficacy. VRPs are new biotechnology tools that better deliver vaccines to cells and also prompt stronger immune responses.
CSSI Lifescience™ and BioMARC announce a partnership to provide a single-source bio-pharmaceutical manufacturing and clinical solution
January 9th 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.
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.
“BioMarc is well positioned to contribute advanced manufacturing assets to important global problems such as Ebola,” said CSU’s Vice President for Research Alan Rudolph. “It is a unique asset for CSU, and we are excited to help the Defense Department execute this important vaccine development program.”
February 24, 2016- Since the Zika virus was first reported in Florida and Texas, Colorado State University has been researching the virus and working to help improve how states across the country test for viruses carried by mosquitoes. Most recently, CSU’s BioMARC, the university’s vaccine manufacturing facility, created material to be used in labs nationwide in the fight against Zika.
BioMARC specializes in handling infectious disease agents, as opposed to a general laboratory. The team is developing a vaccine for the Venezuelan equine encephalitis virus — as a subcontractor for Battelle— and has successfully met research milestones established by the Department of Defense for Ebola and Marburg virus, and Western and Eastern equine encephalitis viruses.
BioMARC of Colorado State University awarded contract to support HIV vaccine production
January 6th 2014– Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) of Colorado State University (CSU), was recently awarded a new contract to support future manufacturing of an HIV vaccine. This is the first of four additional planned contracts that support the development and manufacturing of a Phase II product. The sponsor is un-named for confidentiality reasons.
“HIV prevention and treatments continue to capture worldwide attention and are significant priorities within the United States. CSU-BioMARC is very proud to support the development of this HIV Vaccine through our sponsor. The goal is to have a tremendous global impact with regard to the prevention of HIV infections” as stated by Dr. Pierro, Director of BioMARC. The CDC reports that approximately 50,000 people in the United States are infected with HIV each year. In 2013, 2.1 million new cases of HIV were reported worldwide.
This is the third award to BioMARC from this Sponsor and follows the successful completion of an earlier process development contract that was awarded in 2012.
BioMARC is both FDA approved & performs under Good Manufacturing Practice (GMP)
November 11, 2013 — Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) of Colorado State University (CSU), has recently completed an inspection by the US Food and Drug Administration (FDA) as part of a planned pre-approval inspection (PAI) for a biological product license.
The Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) at Colorado State University (CSU) is expanding resources and expertise through the recent acquisition of management responsibilities of a state of the art biologic Good Manufacturing Practice (GMP) facility at the Research Innovation Center (RIC) on CSU’s Foothills campus. Commonly known as the “RIC-GMP” building, the facility represents CSU and BioMARC’s continued dedication toward the advancement and translation of biological products for human use.
Kathleen Delehoy, Senior Associate Vice President for Research at CSU stated, “[t]his first-ever PAI inspection at CSU is a huge accomplishment for the BioMARC team and CSU. It signifies that BioMARC has a highly accomplished and professional team with a robust Quality System in place. It also demonstrates that BioMARC is moving in the right direction when it comes to cGMP Manufacturing of Biologic products, in particular the BSL-3 manufacturing.”