Novel therapies are revolutionizing the treatment of diseases such as cancer, neurological disorders, and various genetically inherited conditions. The production of cell and gene therapies, mRNA vaccines, and anti-sense oligonucleotides, are critical for patients in need to significantly improve or even eliminate their health issues.
We at DPS truly understand the challenges you face with the manufacturing of your advanced therapy medicinal products (ATMP). From expertly designed facilities and regulatory knowledge to constructing a new laboratory facility, or redesigning an existing space for a new therapy, we put your needs first, so that you, in turn, can produce high-quality leading-edge therapies, on time, and within budget. We are here to help you deliver life-changing therapies to your patients.
Many advanced therapeutics companies are at the frontier of this next-generation medicine, harnessing the potential to successfully treat previously untreatable conditions and have entrusted the DPS team to design, construct, and validate their new facilities.
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Meet our subject matter experts
Dr. Aidan Harrington, BSc.Micro., PhD. Molec.Biol., DPS Principal Consultant, has been working in the Pharmaceutical Industry since 1992. Aidan has worked in QA, Validation and Engineering roles in manufacturing and capital project environments for the pharmaceutical industry and is an expert in US FDA and EU cGMP regulations. He has extensive regulatory inspection exposure experience, both FDA and EMA and participates in facility readiness programs for a wide range of clients, in traditional biologics, advanced therapeutics (ATMPs) and aseptic filling.
Aidan has played significant roles on the planning and implementation of CQV programs for large capital projects including implementation of Quality Risk Management principles from concept design phases to PV/PPQ. Aidan provides consultancy in areas such as cGMP compliance, risk assessments, technology transfers, CDMO audits, pre-inspection readiness audits, CQV and quality program strategies and quality remediation. Aidan’s experience covers all aspects of biologics including cell and gene therapy advanced therapeutics, (ATMPs), drug substance and drug product, aseptic filling. He is a on the PDA SIG for the BSR PDA Standard 03-201x, Standard Practice for Quality Risk Management of Aseptic Processes.
Stephen is a Bioprocess specialist with 20 years of experience in the Biopharmaceutical sector. He has worked across a range of design, start-up, and operational roles in Biologics facilities with various international clients. Stephen has a particular interest and expertise in advanced facilities, with a focus on novel therapies, cell and gene, and single-use facilities. He is an expert in bioprocess design activities from concept through delivery as well as working directly with clients to execute technology evaluations and process improvements.
Emily is a process engineer, specializing in biological process and facility design. Working in the life sciences for over 20 years, she has gained expertise in designing facilities for monoclonal antibodies, vaccines, and gene therapy production, both in stainless steel and single-use. She is industry-recognized for her subject matter expertise in multi-modal facilities where different product types are produced in the same facility, due to her deep knowledge of complex facility layouts, GMP flows, and regulatory considerations.
As a top-level technical expert for DPS Group, Emily will support clients by leveraging her extensive experience to track and identify the next breakthrough technologies in the life sciences industry. Based in Cary, North Carolina, she will drive innovation and thought leadership for DPS, globally, by challenging the status quo.
A graduate of North Carolina State University, Emily holds two degrees: a Bachelor of Science in chemical engineering and Bachelor of Science in biochemistry. She is also a licensed Professional Engineer in the state of North Carolina and an active member of the International Society of Pharmaceutical Engineers (ISPE).
Dr. Rory Heffernan is a senior bioprocess engineer and simulation specialist with DPS. He works with simulation and modeling tools to support the design of innovative biologics clients with a primary focus on cell and gene therapy facilities with single-use technologies. He works closely with clients in early project phases to develop optional operational strategy models to help layout and design the facility in association with the process engineers and architects.