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.
