
Company
Leadership in AAV Gene Therapy
Our Vision
Bringing life-saving and life-altering cell and gene therapies to all.

A Partner You Can Trust in Cell and Gene Therapy
We leverage our extensive expertise in adeno-associated virus (AAV) gene therapy to efficiently and effectively create the life-saving and life-altering treatments that have the potential to transform patients’ lives.
Because of our extensive experience and understanding of cell and gene therapy—and our unwavering focus on quality— you can be sure our suite of services will meet expectations.
Product quality?
Confirmed.
Product quantity?
Assured.
Our Fully Equipped Cell and Gene Therapy Facility
Our Greater Boston area site is equipped for
2, 50, and 2000L scales for process development
500L for GMP manufacturing.


Close to Boston and Cambridge, near some of the best educational institutions,
we have a vast array of scientific and business expertise.
Oxford Biomedica’s state-of-the-art,
91,000-sq-ft cell and gene therapy manufacturing facility provides full-scope process and analytical development, and GMP manufacturing.


Our facility is equipped to
support multiple products concurrently
offers single-use technology, eliminating potential for cross-contamination.

Our Plasmid Systems
The Full Solution™ suite of services has the
flexibility and adaptability to support both dual- and triple-plasmid transfection systems
design and optimization to maximize performance and increase product quality
Rigorous analytics have helped optimize both dual- and triple-plasmid system integration, so we can tailor our services to your specific needs.
Our Purification Process
Our proprietary purification process* is extraordinarily adept at separating empty and full capsids. We have demonstrated consistent isolation of full capsids
achieving >90% full AAV vector at commercial scales

*Patent pending.
Plug-and-Play Efficiency, Tailored to Your Specific Needs
Together, these aspects of our process allow us to
- produce your product quickly
- save time and resources
- move your product through drug development, IND or CTA, clinic, BLA, and to market faster to benefit patients
Our Expert Team
Mark Caswell
Site Head of US Operations
Mark Caswell joined Oxford Biomedica as Site Head of US Operations in July 2023. He has more than 25 years of experience and expertise in biopharma and CDMO space. Previously, Mark was Vice President, Site Head, of the leading global CDMO, Rentschler Biopharma, where he successfully managed all operations at the company’s US facility in Massachusetts. Mark has a diverse background in various areas of operations, including service as Head of Operations at Lonza’s Portsmouth, New Hampshire, site and as Director, Global Engineering and Technology, at Sanofi Genzyme. Mark holds a BS in nuclear engineering technology from Thomas Edison State University and is a proud veteran of the US Navy.
Daniel McGrath
SVP, Manufacturing Operations
Daniel McGrath is the Senior Vice President of Manufacturing Operations at Oxford Biomedica USA, with responsibility for facilities, engineering, manufacturing, warehousing, and supply chain. Daniel brings more than 25 years of experience building and leading effective gene therapy and biologics manufacturing organizations. Daniel has been in leadership, integration, and organizational expansion roles at Homology Medicines, Shire, Eli Lilly (previously ImClone Systems), and BASF BioResearch. Daniel also has an extensive background in the design, build, and start-up of facilities that range in size from 25,000 to 300,000 square feet.
CJ Witalisz
SVP, Finance
CJ Witalisz is the Senior Vice President of Finance at Oxford Biomedica USA. CJ brings an impressive track record of leadership in finance. Previously, he was the Vice President of Commercial Strategy and Business Insights at Homology Medicines, where he was responsible for Homology’s accounting operations, SEC reporting, and decision support activities, and provided strategic support for Homology’s private, public, and strategic financing. Prior to Homology, CJ held several finance roles of increasing responsibility at Shire Pharmaceuticals. CJ is a CPA and received a BA from the University of Massachusetts at Amherst and an MBA and MS in accounting from Northeastern University.
Edna Vassilovski
SVP, Legal
Edna Vassilovski is the Senior Vice President of Legal and is responsible for the general legal affairs of Oxford Biomedica USA. Edna is a business-oriented attorney with broad, interdisciplinary experience—both legally and technically. Acting as either in-house or external counsel, Edna has represented private and publicly traded companies of all sizes in a variety of technical fields, including cell and gene therapy, small molecule pharmaceuticals, medical devices, and software. Most recently, Edna was the Chief Intellectual Property Counsel of Epizyme, and in this role led the intellectual property function through the company’s acquisition by Ipsen. Earlier in her career, Edna was a partner at intellectual property law firm Fish & Richardson. Edna is known for her pragmatic, out-of-the-box, thinking, and is committed to collaboratively leveraging her skills within a legal framework to create and build value in support of company goals. A native of Boston, Edna has lived in various parts of the United States and in multiple countries. She holds a BS in chemistry from Stanford University, an MA in chemistry from Harvard University, and a JD from Columbia University.
Michael Mercaldi
VP, Strategy & Program Management
Michael Mercaldi is the Vice President of Strategy & Program Management at Oxford Biomedica USA and leads the program, alliance, and technical CMC management of projects. Previously, Michael led the Purification and Drug Product Sciences teams at Oxford Biomedica. Throughout his career, he has worked in process development at Homology Medicines, Codiak BioSciences, Merrimack Pharmaceuticals, and MedImmune/AstraZeneca. Michael holds a BS in chemical engineering from the Rensselaer Polytechnic Institute and a PhD in biochemical engineering from Tufts University.
Jin Yin
VP, Manufacturing Development & Technology
Jin Yin is the Vice President of Manufacturing Development & Technology and brings more than 20 years of process development, process characterization, process scale-up, technology transfer, and GMP manufacturing support experience to Oxford Biomedica USA. Prior to joining Oxford Biomedica, Jin served as Senior Director of Biologics Process Development at Momenta Pharmaceuticals. Previously, Jin was an Associate Director of Commercial Cell Culture Development at Sanofi Genzyme, a Principal Engineer, Cell Culture Process Development, at Shire Human Genetic Therapies, and a scientist at GlaxoSmithKline Biologicals. Jin received his PhD in biochemical engineering from Tsinghua University and completed his postdoctoral training at the Massachusetts Institute of Technology.
James McGivney
VP, Analytical Development
James McGivney is the Vice President of Analytical Development at Oxford Biomedica USA, with a team focus of driving industry-leading innovation for the next generation of AAV-based gene therapies. Before joining Oxford Biomedica, James led analytical development efforts in cell and gene therapy at Homology Medicines, and prior to that at Spark Therapeutics. James began his industrial career in protein therapeutic development, working at MedImmune/AstraZeneca and Syntonix Pharmaceuticals. After receiving his PhD in pharmacology from the University of Massachusetts Medical School, James completed a postdoctoral research fellowship at Harvard Medical School in the laboratory of Charles C Richardson.
Peggy Dalicandro
VP, Human Resources
Peggy Dalicandro is the Vice President of Human Resources at Oxford Biomedica USA. She is an experienced HR executive and is passionate about creating employee experiences that unlock potential and make work more meaningful. In her more than 20-year career, Peggy has supported organizations at various stages of growth, across multiple industries, and in several countries. She has a proven track record in coaching executives, enabling them to grow, scale, and transform businesses. In the later part of her career, Peggy has held leadership roles at ADP, Amazon, and most recently Alexion, the rare disease unit of AstraZeneca, where she helped drive company performance and employee engagement through progressive talent processes. Known for her ability to build and lead high-performing teams, Peggy has an unwavering commitment to developing and mentoring the next generation of leaders. A native of Boston, Peggy also has lived and worked in multiple countries and has a true global mindset. She holds a BS from Westfield State University.
The Force for Greater Good
Through novel technology, high-level expertise, and an accelerated learning approach, we aim to generate life-altering treatments for all.