Applied DNA Sciences, a company involved in PCR-based DNA technologies, appointed Beverly Wolgast, executive director of Quality and cGMP Programs. 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.

Wolgast brings 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.

Wolgast has a record of mobilizing technical resources and achieving efficient compliance solutions to address business needs. Her 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,” said James A. Hayward, president, and CEO of Applied DNA. “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. 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.”