BioMARC News & Events

BioMARC production supervisor Brandon Marsh and production associate Nicole Kelly calibrate a bioreactor

CSU’s BioMARC Extends Partnership with Sumagen on HIV Vaccine, Initiates cGMP Manufacturing for Phase II Human Clinical Trial

November 12, 2019- With a recently signed contract for the manufacturing of an HIV vaccine candidate, CSU’s BioMARC and Sumagen Co., Ltd are pleased to report substantial progress on the development of this much needed vaccine. The path to take a novel vaccine candidate from early experiments through the human clinical trials required to gain eventual approval can be a long and difficult process. Dr. John Wyckoff, BioMARC’s director, commented on this latest milestone, “Sumagen and BioMARC have had a very productive partnership for several years. At this point in the development, BioMARC has successfully manufactured both pilot-scale and full-scale engineering runs for Sumagen’s whole-inactivated HIV vaccine candidate. We are now moving forward with the cGMP manufacturing run to produce the vaccine that will be used in Sumagen’s Phase II human clinical trial and our entire team is excited to contribute to this very promising project.”

Phase II studies test the efficacy of a vaccine, and can involve up to several hundred patients. This vaccine candidate successfully completed a Phase I clinical study to assess the safety, tolerability, and immune response of the vaccine; of which there were reported no serious adverse effects while boosting antibodies in the volunteers. According to estimates by WHO and UNAIDS, 36.7 million people were living with HIV globally at the end of 2016. That same year, some 1.8 million people became newly infected, and 1 million died of HIV-related causes. An estimated 1.1 million people in the United States had HIV at the end of 2016, the most recent year for which this information is available. Of those people, about 14%, or 1 in 7, did not know they had HIV. Antiretroviral drugs that fight HIV by stopping or interfering with the reproduction of the virus in the body, are helping people live longer and healthier with the virus than ever before, but with a vaccine candidate such as this it could prevent people getting infected in the first place.

The production process utilizes BioMARC infrastructure and expertise working in high containment (Biosafety Level 3) manufacturing under US FDA regulated cGMP conditions. Regular meetings between Sumagen personnel and the BioMARC team which had been optimizing the manufacturing process have helped move the project through key milestones with a strong degree of alignment and with a positive sense of partnership.

For more information please visit: https://www.research.colostate.edu/idrc/

Rift Valley Disease MosquitoCEPI Awards Funding Agreements Worth up to US $9.5 Million to Colorado State University to Develop a Human Vaccine Against Rift Valley Fever

Oslo, Norway, July 17, 2019- The Coalition for Epidemic Preparedness Innovations (CEPI) and Colorado State University (CSU) today announce a partnering agreement to advance the development of a vaccine candidate against Rift Valley fever (RVF) virus. With support from the European Union’s (EU’s) Horizon 2020 programme, CEPI will provide up to US $9.5 million for manufacturing and preclinical studies to assess a single-dose vaccine candidate (DDVax) against RVF. First identified in 1931 during an investigation into an outbreak among sheep on a farm in the Rift Valley of Kenya, this potentially fatal virus is found across Africa and is now emerging in the Middle East.

DDVax is a second generation RVF vaccine, which was designed after researchers identified and removed the key genes of the virus that allowed it to cause disease. Removal of these genes also stops the virus from replicating in mosquitoes—a known vector that spreads the disease in animals and in humans—therefore blocking this potential route of transmission. The vaccine stimulates the body’s immune system to generate neutralizing antibodies against the RVF virus. It also likely generates a significant cellular immune response that can kill infected cells.

This investment is part of CEPI’s third call for proposals, launched earlier this year with support from the EU’s Horizon 2020 research and innovation programme under grant agreement No. 857934. Since the launch of this call in January 2019, $43 million has been invested in one Chikungunya vaccine and two RVF vaccine candidates (including DDVax).

About Rift Valley fever

RVF is caused by a virus transmitted by mosquitoes and blood-feeding flies that usually affect animals, including cattle, goats and sheep. However, the virus also infects animals and humans through direct contact with the blood, tissues, or organs of infected animals. RVF mainly affects people living in pastoral communities in low-income and middle-income countries.

 

“We’re delighted to partner with Colorado State University to develop a human vaccine against Rift Valley fever virus. This vaccine will be the 24th candidate to join CEPI’s portfolio. Rift Valley fever has substantial epidemic potential. The world needs to accelerate its efforts to develop a vaccine against this deadly virus, and that’s exactly what we aim to achieve through this collaboration. By supporting the development of Rift Valley fever vaccines, CEPI hopes to improve global health security and strengthen the world’s epidemic-preparedness capacity.” -Richard Hatchett, CEO of CEPI

 

RVF vaccines have been used successfully to protect livestock, but no vaccine has been licenced for use in humans.

RVF can cause severe symptoms and kills about one in every hundred people it infects. In people who develop the hemorrhagic form of the disease, the fatality rate is as high as 50%.

Between May and June 2018, concurrent cases of RVF were reported in farmers in South Africa and Kenya, nearly 5000 km apart. There is also an ongoing outbreak on the island of Mayotte, a French overseas territory in the Indian Ocean. As of July 5, 2019, there have been 141 human and 124 animal cases of RVF confirmed on the island.

 

“We are excited to partner with CEPI and to work towards manufacturing a Rift Valley fever vaccine for humans. Our team and UC Davis are well-positioned to develop this much-needed medical countermeasure to reduce suffering and mortality from this disease” -Alan Rudolph, Vice President for Research at CSU

 

In view of the epidemic threat posed by RVF virus, the World Health Organization has classified it as a priority pathogen in need of urgent R&D investment.

About DDVax

DDVax was developed more than 10 years ago by researchers at the Centers for Disease Control and Prevention’s (CDC) Viral Special Pathogens Branch. Data for preclinical studies show that the vaccine is safe, fully protective, and well-suited for large-scale production. These attributes position DDVax well as a highly promising countermeasure for humans.

The CDC researchers who developed DDVax include Dr. Brian Bird, who is now a research virologist at the One Health Institute at the University of California, Davis; Cesar Albariño and Stuart Nichol of the CDC; and Dr. Thomas Ksiazek, now at the University of Texas Medical Branch.

The consortium for this project was assembled by and is lead by Dr. John H. Wyckoff III of CSU. As part of this project, UC Davis’ One Health Institute will be working with CSU to further evaluate the safety and immune-system responses induced by DDVax to provide sufficient evidence for regulatory approval to advance the vaccine into phase 1 clinical trials in areas where RVF is endemic.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations launched in Davos in 2017 to develop vaccines to stop future epidemics. CEPI has received multi-year funding from Norway, Germany, Japan, Canada, Australia, and the Bill & Melinda Gates Foundation, and Wellcome. CEPI has also received single-year investments from the Government of Belgium and the United Kingdom. The European Union provides financial support for relevant projects through their Horizon 2020 programme as well as through the European and Developing Countries Clinical Trials Partnership. CEPI has reached over US$ 750 million of its $1 billion funding target. Since its launch in January 2017, CEPI has announced three calls for proposals. The first call was for candidate vaccines against Lassa virus, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and Nipah virus. The second call was for the development of platforms that can be used for rapid vaccine development against unknown pathogens. The third call is for candidate vaccines against Chikungunya and Rift Valley fever viruses. To date, CEPI has committed to investing over $390 million in vaccine development. This includes 17 vaccine candidates against its priority pathogens (six against Lassa virus, five against MERS-CoV, three against Nipah virus, one against Chikungunya, two against Rift Valley fever) and three vaccine platforms to develop vaccines against Disease X. To assess the effectiveness of these platforms 7 additional vaccine candidates are being developed (two against influenza, one against Marburg virus, two against Rabies virus, one against Respiratory Synctial Virus, and one against yellow fever).

Learn more at CEPI.net. Follow us at @CEPIvaccines.

More information is available at www.colostate.edu.

PipetteWhy It’s Important to Study Neglected Diseases: A Conversation with BioMARC’s John Wyckoff

July 17, 2019– On July 17, Colorado State University received an award worth up to $9.5 million to develop a human vaccine against the Rift Valley Fever virus. John Wyckoff, the university’s principal investigator for the project, which is funded by the Coalition for Epidemic Preparedness Innovations (CEPI), spoke with SOURCE recently about what it means for CSU and global health.

Wyckoff is the director of the Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC), a nonprofit contract development and manufacturing operation owned and operated by CSU to produce vaccines, therapeutics, diagnostics and other biopharmaceutical products. BioMARC is part of the Infectious Disease Research Center administered through the Office of the Vice President for Research at CSU, headed by Alan Rudolph.

How did CSU decide to take on this vaccine development project?

At BioMARC, we help biotech companies, large pharmaceutical companies and government agencies develop products that require specialized biological containment. BioMARC’s function is to serve as a stepping stone between discovery and development. Our team helps generate vaccine or diagnostic material that goes into preclinical studies in the lab. We also work toward manufacturing material for clinical studies, when products are tested in people.

CEPI had a call for proposals early this year. When that call came out, it was a great fit for what BioMARC does. Around 10 years ago, when I was working at Merial, a global animal health company, I was aware of this particular vaccine candidate, which is also why this project was appealing to me. A ‘vaccine candidate’ means that it has promise to be safe and to be effective, but it has not yet been approved by a regulatory agency for use in people.

How long have you been interested in infectious disease research and how did that start?
Director of BioMARC, John H. Wyckoff, III
John H Wyckoff, III, Director of BioMARC, Research and Innovation Center, Colorado State University.

I’m an immunologist who has been focusing on development of vaccines against infectious diseases for animals and people my entire career. I had one professor in graduate school who not only was able to identify a fascination or ‘hot button’ I had for immunology, but he also stomped on it regularly, which challenged me, in a good way.

It remains a fact to this day that vaccination is the most cost-effective avenue for reducing infectious diseases that we know. It doesn’t matter whether you’re talking about animals that are raised for food, pets, or people.

Who are the partners CSU will be working with on this project?

BioMARC is leading this research project, and we have about 20 people involved at our facilities. We are also working with two faculty members at CSU who have both experience and interest in Rift Valley Fever virus: Assistant Professor Rebekah Kading and Professor Dick Bowen. They are both in the College of Veterinary Medicine and Biomedical Sciences and were natural additions to the team.

The vaccine that we will be testing was developed by the Viral Special Pathogens group at the Centers for Disease Control and Prevention. Stuart Nichol — who was the head of that group — and Brian Bird — also one of the inventors who is now at University of California, Davis — are also part of the project team at this point. There will be several phases to this project, and new partners to announce moving forward.

How would you describe CSU’s expertise in infectious disease research?
mmunology and Pathology, has been studying Rift Valley Fever for years. Photo: John Eisele/CSU Photography
Rebekah Kading, Assistant Professor of Microbiology Immunology and Pathology, is working on a vaccine for Rift Valley Fever, a virus transmitted by mosquitoes.

CSU has a long-standing international reputation of excellence for work in mycobacterial diseases, in particular tuberculosis. We have a lot of scientists who have really strong reputations in the infectious diseases research realm, not only in veterinary medicine but also in zoonotic diseases – ones that cross between humans and animals, like Rift Valley Fever – and vector-borne diseases – those that are transmitted by mosquitoes and ticks as well as other arthropods.

What should people know about Rift Valley Fever virus?

We do not yet have Rift Valley Fever in the United States. However, the virus is endemic throughout sub-Saharan Africa, and outbreaks usually occur in pastoral communities in lower-income countries. These rural communities have reduced access to public health services and their livelihoods are often closely linked to their livestock, which also happen to be a main amplifier for the Rift Valley Fever virus and exposure risk for people.

There is an urgent need to develop a vaccine for humans to mitigate this emerging epidemic threat, protect these vulnerable communities, and strengthen global health security in the process.

Rift Valley Fever is a fairly mild disease in most people. It causes a flu-like illness and most people recover in a week or two. However, there are a couple of serious forms of RVF infection, in particular one known as a hemorrhagic form, where the fatality rate can be as high as 50 percent.

For most cases of Rift Valley Fever, the overall fatality rate is about 1 to 2 percent.

In the United States, we do actually have mosquitoes that are capable of transmitting RVF virus, mostly through the Aedes and Culex species, as well as a few other species. There are similar species also found in continental Europe, so there is a risk of Rift Valley Fever spreading to other countries outside of sub-Saharan Africa.

Over the last 20 years, the virus has expanded in its reach. In the last 10 years, it has moved into the Arabian Peninsula, northeast of Africa, and Madagascar. In 2019, the island of Mayotte, which is northwest of Madagascar, has an ongoing outbreak of Rift Valley Fever among people and livestock.

Why are zoonotic diseases particularly worrisome in terms of public health?

Zoonotic diseases are particularly worrisome because most of our livestock enterprises in the U.S. are intense, meaning that we have large numbers of highly-susceptible animals confined in close proximity. You couldn’t ask for a better situation for a pathogen to come in, sweep through a barn full of broiler chickens, egg-producing hens, swine, or dairy cattle or feedlots for beef cattle. Diseases can potentially just sweep through situations like this.

If it’s a zoonotic disease, the people who take care of the animals can be at risk, and vice versa.

What draws you to work with vaccines? And is there a difference working in a university or industry setting?

Starting in graduate school, my interest was in immunology, and the big accomplishment of immunology that has done the most good is vaccine development. As I advanced in my career, I saw that in academia, to get a product developed and into the field where it did something good, was exceptionally difficult and time-consuming.

In industry, everything is about generating products. BioMARC is very much like a small company embedded in the university. I would describe us as 5 percent academic and 95 percent company-oriented, and that’s pretty unique.

That’s how I can give back to society, to develop things that benefit society in a large way.

CMA Bioscience/Medical Manufacturer of the YearCMA Bioscience Meeting Group Picture

Infectious Disease Research Center /BioMARC Awarded  the 2019 Colorado Bioscience/Medical Manufacturer of the Year

April 8, 2019– All, We wanted to share with you some wonderful news. Last week, the Infectious Disease Research Center was honored as the winner of the Colorado Manufacturing Awards (CMAs) for 2019 Bioscience/Medical Manufacturer of the Year. The announcement came at the 4th Annual CMAs gala reception held on April 4, 2019 at the Cable Center on the Denver University campus. Approximately 200 people representing various manufacturing entities from Colorado, Wyoming and New Mexico, the national organization – Manufacturing Extension Partnership and representatives from IDRC/BioMARC and the CSU Office of the Vice-President for Research. The selection of the IDRC was made on the basis of its program of work in supporting the development and manufacture of diagnostics, therapeutics and vaccine products on behalf of government, academic and private sector organizations carried out under the BioMARC operation led by John Wyckoff, Joanna Ellinghuysen, Darragh Heaslip, Celeste O’Connor, JaNae Myers, and Sandy Brown and an incredible team of Research Associates, administrative professionals, students and staff.
The nomination of the IDRC was made by Dan Powers, Director of the CO-LABS organization that represents and advocates for government-sponsored research groups and facilities in the state of Colorado. Dan has been a great supporter of the IDRC and with the help of Howie Carpenter, assembled a highly supportive informational package to submit to the review panel. That submission included background and a description of the RBL, RIC and BioMARC operations of the IDRC and the role that they play in supporting innovation, education and manufacturing related programs in the fields of bioscience and medicine. The following is the description that was read at the ceremony:

The Infectious Disease Research Center (IDRC) at the foothills campus of Colorado State University is a unique and lively hub of translational biology that integrates academic research, entrepreneurial companies, and a world-class bio-manufacturing operation unified under one roof. Featuring one of the nation’s most significant infrastructures for working with high consequence pathogens, industry and academic researchers can mingle as they apply cutting edge biotechnology tools to address some of the world’s most pressing health threats. Bio-manufacturing of drugs to be used in clinical trials is performed under FDA regulated conditions within a high containment environment.

The recognition that comes from peers is often the most highly prized. We clearly know of the exciting and impactful work that goes on day in and day out in the Foothills, supported by countless people in the CSU community who often work behind the scenes to keep our operations running smoothly and efficiently day in and day out, providing opportunity for the delivery of much needed results with often highly challenging objectives. It is wonderful to know that others in our community see this value too. This award is not for any single organization or individual. It is for our entire CSU community that shares in this. It reflects upon and speaks to the mission that we have as a public institution of higher learning, founded on the principles of returning value through the education and training of students, enhancing opportunities for groundbreaking academic research and staying true to a mission to deliver value in response to the needs of our community on a local, national and global basis.
The award came with a crystal tower, a photo of which is attached. We will be placing this in a display case in the lobby of the IDRC in the near future.

Congratulations to all of you on this recognition of your achievements!

For more Background on the Colorado Manufacturing Awards, please visit the article link.

CSU’s Infectious Disease Research Center Named Finalist for Outstanding Bioscience / Medical Manufacturer of the Year

February 27, 2019-  The Colorado Manufacturing Awards are the only program of their kind in the United States, and bring together the region’s leaders to celebrate the modern manufacturing economy.  Sponsored by CompanyWeek and Manufacturers Edge, Colorado’s National Institute of Standards Manufacturing Extension Program, winners will be announced April 4, 2019.  Finalists in all categories are described on CompanyWeek’s website.

Dr. Raymond Goodrich, Executive Director of the Infectious Disease Research Center (IDRC) commented, “It is always rewarding to know that others see the value that we represent to our community at a local, national and international level.  That is only possible because of the tremendous efforts made by all of the IDRC staff and associates in supporting the Regional Biocontainment Lab (RBL), Research Innovation Center (RIC) and the Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC).  Congratulations to all of them for making it to the list of finalists for this award of recognition and thank you for the job that you do here on a day to day basis.”

Boston Children's Hospital LogoBioMARC Awarded Typhoid Vaccine Manufacturing Project for Boston Children’s Hospital

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.”

Director of BioMARC, John H. Wyckoff, III
John H Wyckoff, III, Director of BioMARC, Research and Innovation Center, Colorado State University, October 2. 2017.

New Director Joins BioMARC

October 10, 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.

Mosquito on arm
Colorado State University’s Arthropod-Borne and Infectious Disease Laboratory researches Zika virus in Aedes aegypti mosquitos. This mosquito was not infected wth the virus. February 24, 2016

CSU Works with CDC to Help Public Health Labs Detect Zika Virus

March 30, 2017- 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.

USA Department of Defense
USA Department of Defense works with BioMARC to advance vaccine development

 

BioMARC Secures $3 Million from the Department of Defense to Advance Vaccine Development

February 24, 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.

January 9, 2017 – CSSi LifeSciences™
January 9, 2017 – CSSi LifeSciences™

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.”

BioMARC is currently studying HIV Vaccines.
BioMARC is currently studying HIV Vaccines.

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.”

BioMARC news is also featured in  CSU SOURCE