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biologics

  • sam patrick posted an article
    CRO sells to Singapore company see more

    A Charleston-based medical firm that conducts clinical research for the biopharmaceutical industry is being acquired by a Singapore company that’s looking to expand its reach in the U.S. market.

    Novotech, which has an office in Boston but has primarily provided contract-based clinical services in the Asia-Pacific region, will take on NCGS’ roughly 300 employee and a client base that has been built over the past 38 years.  Financial terms of the sale were not disclosed.

    The Charlotte Street company said on its website that it has conducted research for 80 approved drug, biologic, diagnostic and device products for the medical industry.

    “We have a similar cultural fit and focus on excellence, so joining Novotech will be seamless for both ours and Novotech’s clients,” NCGS founder Nancy C.G. Snowden said in a written statement.

    Snowden, a onetime owner of Carolina’s restaurant on Exchange Street in downtown Charleston, said the two companies have previously collaborated on research.

    “NCGS focuses on complex areas of clinical development, oncology, hematology, infectious disease and CNS (central nervous system) in both adult and pediatric populations,” Snowden said. “Our lean organizational structure and nimble operational model with highly tenured staff have been specifically designed to overcome the challenges inhibiting our industry today. We have the ability to pivot in real time as the needs of the trial evolve.”

    Novotech CEO John Moller said called the acquisition “a strategic move to provide U.S.-based expertise and infrastructure for our U.S. clients wanting trials” in both the Asia-Pacific and domestic markets, as well as for Asia-Pacific clients wanting to U.S. clinical programs.

    “Clients will receive seamless service, with a unified approach to systems and standard operating procedures well developed,” he said.

    Privately held NCGS is headquartered at 16 Charlotte St. on the peninsula’s historic Wraggsborough neighborhood. It bought the building for $4.95 million in July 2016, when the business was based on Broad Street, and spent $10 million on renovations before the site became operational in the spring of 2017.

    NCGS is the third major acquisition for Novotech in recent years. The company in 2018 bought out the Clinical Network Services research group, which gave it a customer base in the U.S., New Zealand and Australia, according to a report by Endpoints News. In 2020, the company raised $59 million in venture capital to purchase London-based ASLA Venture, which had backed oncology-based companies Epsilogen and Oxford Biotherapeutics, according to Endpoints.

    Prior to founding NCGS, Snowden was the senior nursing lead for a National Institutes of Health and National Cancer Institute grant at the Medical College of Georgia/University Hospital. She also established a community clinical oncology program at the hospital, and oncology trials were an early focus for her company.

  • sam patrick posted an article
    Dr. Delphine Dean of Clemson honored see more

    The Governor’s School for Science + Mathematics (GSSM) was pleased to award the Fall 2021 Randall M. La Cross Distinguished Leadership Award to Dr. Delphine Dean of Clemson University at the 33rd Annual Research Colloquium. 

    Dr. Delphine Dean is the Rob and Jane Lindsay Family Innovation Professor of Bioengineering at Clemson University. Dr. Dean earned her B.S., M.Eng., and Ph.D. in Electrical Engineering and Computer Science from the Massachusetts Institute of Technology. She joined the Clemson University faculty in 2007. She is a member of the American Chemical Society, American Physical Society, Materials Research Society, Biomedical Engineering Society, Society for Biomaterials, American Society for Engineering Education, the Orthopaedics Research Society, and is one of the newest members of the American Institute for Medical and Biological Engineering’s College of Fellows. Dr. Dean is a recipient of the Class of ’39 Award for Excellence from Clemson University. 

    Dr. Dean’s Multiscale Bioelectromechanics Lab at Clemson University studies the mechanics and interactions of biological systems at the nano-to micro-scale using techniques like atomic force microscopy and mathematical modeling. Her research focus includes the nanostructure of cardiovascular cells and tissues, the effects of ionizing radiation, and the development of novel medical devices. These innovations include saliva-based blood glucose strips that can be read by a smartphone application and a biodegradable marker for tumor localization that reduces the cost of breast cancer surgery. 

    Many of the projects led by Dr. Dean address needs in under-resourced communities around the world – a commitment aligned with that of GSSM’s mission to develop “ethical leaders” prepared to take on “the world’s most significant issues.” These efforts include a breast pump with a filter to inactivate HIV in breast milk, basket-woven braces for neck injuries that can be produced and sold by local women in Tanzania, and a low-cost patient monitor that a hand crank can power. 

    In response to the COVID-19 pandemic, Dr. Dean led the establishment of the certified clinical diagnostic Research and Education in Disease Diagnosis and Intervention lab at Clemson, which is key to Clemson’s COVID-19 testing strategy, as well as providing testing for their surrounding community. She also led the Clemson COVID Challenge, an undergraduate research, and design challenge to address issues related to the pandemic. 

    A core element of Dr. Dean’s work has been to engage students below the graduate school level with challenging and meaningful projects. Dr. Dean has provided mentored research & inquiry experience to over a dozen GSSM students since 2008 and over 150 Clemson undergraduates through Clemson’s Creative Inquiry program. Current student projects include designing medical devices for the developing world, collaborating on biomedical engineering innovation with students in Tanzania, testing radiation for biomedical applications, using magnetic nanoparticles to reduce the need for arterial stent implants, and applying human factors engineering to medical device design. 

    The Randall M. La Cross Distinguished Research Leadership Award is presented to Dr. Dean by Dr. Tyler Harvey. Dr. Harvey is a GSSM Class of 2011 graduate. As a rising senior at GSSM, he conducted his mentored research & inquiry experience at Clemson University under Dr. Dean. He returned to Clemson, earning his B.S., M.S., and Ph.D. while continuing research with Dr. Dean. Dr. Harvey is currently a Lecturer in Bioengineering at Clemson University and has contributed to the development of GSSM Outreach & STEM Foundations programs.

  • sam patrick posted an article
    More than 43,500 women are expected to die from breast cancer in 2021 see more

    Compliments of Greenville Journal

    A Clemson University study could lead to new immunotherapy for breast cancer. The study, according to the university, provides the foundation of using cells in our bodies to target cancer cells.

    Clemson researchers have used the immune system’s natural killer cells — which the body uses to fight off certain types of infections — to go after the breast cancer cells by bridging the two cells with a fusion of proteins the researchers developed.

    “The idea is to use this bifunctional protein to bridge the natural killer cells and breast cancer tumor cells,” said Yanzhang “Charlie” Wei, a professor in the College of Science’s Department of Biological Sciences. “If the two cells are brought close enough together through this receptor ligand connection, the natural killer cells can release what I call killing machinery to have the tumor cells killed.”

    Breast cancer kills 43,000 women each year in the U.S., according to the American Cancer Society and one in eight women and one in 1,000 men will develop invasive breast cancer.

    “Very simply, cancer is uncontrolled cell growth. Some cells will become abnormal and have the potential to become cancer,” Wei explained. “The immune system can recognize these abnormal cells and destroy them before they become cancer cells. Unfortunately for those who develop cancer, the immune system is not working very well because of gene mutations and environmental factors. The result is that the cancer cells won the fight between the immune system and the tumors.”

    Clemson’s researchers focused on triple-negative breast cancer, the most lethal type of breast cancer, and prolactin receptors.

    Read the full article by clicking here...

  • sam patrick posted an article
    New Jersey firm expands into South Carolina see more

    Courtesy of Charleston Regional Business Journal

    A biopharmaceutical company has opened a Goose Creek facility as part of its goal to establish 10 or more collection centers around the country by 2024, the company said in a news release..

    New Jersey-based ADMA Biologics Inc. is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics.

    Adam Grossman, president and CEO, said South Carolina and Gov. Henry McMaster expressed strong support for opening the new facility.

     “The state’s impressive infrastructure and skilled workforce create a terrific foundation for ADMA to safely collect and process plasma, and we look forward to continuing to grow our operations in the state now and in the coming years,” he said in a statement.

    McMaster was on hand April 23 for a ribbon cutting ceremony, which Grossman said helped create an even stronger beginning for the company.

    Beneath the corporate umbrella, ADMA has seven plasma collection facilities at various stages of approval and development. The Lowcountry plasma center, located at 214 Saint James Ave., is the newest and is projected to need up to 50 health care workers at full capacity.

    “Securing raw material plasma supply has never been more important than it is today, and we believe the series of recent acquisitions of plasma collection facilities validates this scarcity value,” Grossman said.

    The Goose Creek center includes automated registration, high-tech collection equipment designed to shorten the donation process, free WiFi and individual flat-screen TVs at each donor station and trained, certified staff.

    The company is on track to achieve its 2024 goal and Grossman said the expansion will support ADMA’s goal of producing “quarter-over-quarter revenue growth throughout 2021 and beyond.” The Goose Creek operations also will help ADAM create a fully integrated and self-sufficient plasma supply chain, ensure continuity of product supply and generate asset value for shareholders, the company said.

    ADMA plans to file an application for a biologics license and anticipates a standard 12-month BLA review period by the Food and Drug Administration.

    Until then, ADMA is allowed to collect plasma donations on site. Following the FDA’s approval, the company can then use the collections for further use in the manufacturing of life-saving therapies.  

  • sam patrick posted an article
    Alcami's $17 million investment is expected to create 30 new jobs see more

     Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced plans to expand the company’s current operations in Charleston County. The $17 million investment is expected to create 30 new jobs.

    Operating in North Charleston since 2001, Alcami offers a variety of solutions tailored to small and midsized pharmaceutical and biotechnology companies.

    Located at 4221 Faber Place Drive in North Charleston, S.C., Alcami will add approximately 6,000 square feet to the footprint of its facility, substantially augmenting the capacity of its sterile drug product development and manufacturing operations.

    The company’s expansion is expected to be completed in 2021. Individuals interested in joining the Alcami team should visit https://www.alcaminow.com/alcami-careers

    The Coordinating Council for Economic Development has approved job development credits related to the project.

    QUOTES

    “The build-out of our Charleston facility comes at a time of rapid growth for Alcami and represents a long-term commitment to our sterile drug product clients, our talented workforce and the greater Charleston area. Our clients expect the most advanced manufacturing technologies and capabilities, and this expansion will ensure we continue to exceed marketplace expectations by remaining on the forefront of industry needs.” -Alcami Site Director Darold Hill

    “When a company like Alcami Corporation continues to invest in our state and our people, it shows the businesses around the world that South Carolina is the place to be. We look forward to seeing this great company continue to grow and thrive for years to come.” –Gov. Henry McMaster

    “We’re excited to see the continued success of Alcami Corporation in Charleston County and the success of our state’s thriving manufacturing industry. We congratulate them on this newest announcement and the creation of 30 new jobs.” –Secretary of Commerce Bobby Hitt

    “The growth of Alcami Corporation during its 18 years in North Charleston has been truly remarkable. This company is a highly-valued corporate citizen, and with this expansion, it is renewing its steadfast and long-standing commitment to our community.” –Charleston County Council Chairman Elliott Summey 

    “We applaud Alcami’s accomplishments in our local economy, building upon their company’s innovation, which is backed by a proven workforce. North Charleston remains ripe for businesses to flourish, and we are always grateful for the benefits our community receives when companies succeed.” –North Charleston Mayor Keith Summey

    “Congratulations to Alcami on announcing their second expansion in Charleston County in the last three years. Assisting local companies in their expansion efforts is a primary focus of our Business Concierge program. Our long-standing relationship with Alcami helped support their decision to grow their global footprint at their North Charleston facility.” –Charleston County Economic Development Executive Director Steve Dykes