Experienced Biopharma/Pharmaceutical Executive to Lead Implementation of cGMP-quality LineaDNA™ Capability for IVT mRNA Production
Previously Led Manufacturing Operations Scale-up for the BioNTech/Pfizer mRNA COVID-19 Vaccine at CDMO Division of Maravai LifeSciences
STONY BROOK, NY / ACCESSWIRE / September 6, 2023 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today announced the appointment of Beverly Wolgast, Ph.D., as executive director of Quality and cGMP Programs. Dr. Wolgast will oversee and manage Applied DNA’s quality assurance and control and regulatory compliance spanning the Company’s three business segments, including implementing an ISO 13485-based quality management system for the scalable cGMP manufacture of LineaDNA™.
Dr. Wolgast brings to Applied DNA over 30 years of pharmaceutical and biotech experience in commercial and clinical-stage companies, with a proven track record of quality and regulatory compliance management and expertise in commercial biologics manufacturing operations. Most recently, she was Director of CleanCap® GMP Manufacturing at TriLink BioTechnologies, a contract development and manufacturing organization (CDMO) and division of Maravai LifeSciences, where she also provided leadership for TriLink’s manufacture of the mRNA-based BioNTech/Pfizer COVID-19 vaccine. She is also a strategic and focused leader with a record of mobilizing technical resources and achieving efficient compliance solutions to address business needs. Dr. Wolgast’s expertise includes industry regulatory compliance, program management, operational readiness, process engineering, lab operations, automation engineering, and technical validation.
“Beverly’s wealth of experience and deep knowledge of nucleic acid-based therapy manufacturing will be instrumental in implementing scalable, highly efficient, and consistent quality and manufacturing processes necessary to support Linea™ IVT platform customers from early-stage drug discovery through late-phase clinical trials. A successful operational leader in the CDMO industry, her appointment also signals to CDMOs that are likely customers of our platform that we are moving with intent to help them meet the industry’s need for better mRNA,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “It is an important time for Applied DNA as we advance our LineaDNA commercial activities, and Beverly’s appointment supports our vision for growth and value creation through our biopharma approach.”
“Having witnessed first-hand the transformative power of mRNA-based therapeutics, I have great respect for Applied DNA’s innovative and differentiated approach to nucleic acid manufacturing that has the potential to transform healthcare interventions globally,” stated. Dr. Wolgast. “I am thrilled to work alongside a motivated leadership team intent on making a lasting impression on the future of genetic medicine.”
Over the past 10 years, Dr. Wolgast has held leadership roles within the biopharma industry, including at Biocept, Inc., Diomics Corporation, and, most recently, with TriLink BioTechnologies, where she focused on post-transcriptional capping technologies to create capped mRNA products with shorter manufacturing times, reduced immunogenicity, and increased stability. Dr. Wolgast earned her Ph.D. in Organic Chemistry from Brandeis University and completed a post-doctoral fellowship in applied nanomaterials at Harvard University.
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company that utilizes polymerase chain reaction (“PCR”) to develop and commercialize platforms to produce and detect DNA and RNA. The Company operates in three primary business markets: (i) the manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and diagnostics, and the development and sale of a proprietary RNA polymerase for use in the production of mRNA therapeutics; (ii) the development of molecular diagnostics and genetic testing services based on the detection of DNA and RNA; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’
About the Linea™ IVT Platform
The Linea IVT platform combines cell-free, enzymatically produced Linea™ DNA IVT templates with its proprietary Linea™ RNAP to deliver multiple advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of dsRNA contamination resulting in higher target mRNA yields; and, 3) the delivery of IVT templates in as little as 14 days for milligram scale and 30 days for gram scale.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from the LinearDNA™ and/or Linea™ IVT platforms, limited market acceptance for its supply chain security products and services, the declining demand for Applied DNA’s COVID-19 testing services, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT or LinearDNA platforms approved for therapeutic use, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including its Annual Report on Form 10-K filed on December 14, 2022, as amended, its 10-Q filed on February 9, 2023, May 11, 2023, and August 10, 2023, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, [email protected]
SOURCE: Applied DNA Sciences, Inc.
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