SAN DIEGO--(BUSINESS WIRE)--Abzena today announced that it has appointed Elaine Sapinoso as Senior Vice President of Global Quality to support the addition of new manufacturing suites at 2000L scale at its San Diego site, complex small molecule manufacturing capabilities at its Bristol PA site, and integration of its gene to GMP services.
In this role, Ms. Sapinoso is responsible for the oversight of Quality Assurance, Quality Control, and Analytical Development departments. She is also responsible for regulatory compliance across the Abzena sites reporting directly to Jonathan Goldman, MD CEO. Dr. Goldman commented: “I am delighted to welcome Elaine as our Global Head of Quality. Elaine brings world-class expertise in GMP quality oversight from development through to commercial scale for both large and small molecules. Her experience will help us make our new facilities available to our customers, and allow us to implement commercial scale manufacturing.”
Prior to joining Abzena, Ms. Sapinoso served in senior roles at global contract manufacturing organizations. She was formerly Vice President of Quality and Regulatory at Aji Bio-Pharma (Ajinomoto Althea), where she was responsible for the Quality in Drug Substance, Drug Product and testing operations from early clinical through commercial phase.
Ms. Sapinoso brings over 22 years of Quality and Regulatory experience within the pharmaceutical and biotechnology industries, supporting both large and small molecule drug manufacturing. She has successfully developed quality systems and procedures that have brought manufacturing organizations from clinical development to mature commercial manufacturing in a phase appropriate manner. She has assisted in bringing 11 drug products candidates to commercial approval in 11 countries, with a track record of no critical inspectional findings during pre-approval site inspections.
Ms. Sapinoso stated: “I am very excited to join Abzena and look forward to playing a role in applying the highest quality standards to our integrated manufacturing and testing offerings. I will strive to build partnerships with Abzena customers as we collaboratively provide high quality and safe products to patients in need. I particularly appreciate the opportunity to work for a company like Abzena where the culture is focused on bringing effective products to patients”.
Elaine holds a bachelor’s degree in Biology from De La Salle University. She is licensed as a Designated Representative by the California State Board of Pharmacy, certified as a Quality Technician and maintains active memberships with the Parenteral Drug Association (PDA) and Regulatory Affairs Professionals Society (RAPS).
Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and ADC drug development services in the pharmaceutical industry. The company maintains resources around the world, with facilities in the US and UK. Abzena is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
For more information about Abzena, visit www.abzena.com