FDA Invites Catalent to Present on New Drug Delivery Technologies
Somerset, N.J. – June 26, 2014 — Catalent Pharma Solutions, the global leader in drug development solutions and advanced delivery technologies for pharmaceutical, biologic and consumer health products, was recently invited by the FDA Office of Compliance and Biologics Quality to speak at its Manufacturing Technology Seminar Series. The FDA had specifically requested that Catalent present on its ADVASEPT™
technology, for the advanced aseptic filling of injectable drugs, and Zydis®
, Catalent’s Fast Dissolve technology, which is a unique, freeze-dried oral dosage form that disperses instantly in the mouth, requiring no water.
The FDA holds these events in order to inform the agency on the latest technologies that they could potentially see in future drug filings. The seminar featured presentations from Catalent experts in Advanced Delivery Technologies, followed by a discussion period and Q&A, and was well attended by representatives from both the Center of Drug Evaluation and Research (CDER) and the Center of Biologic Evaluation and Research (CBER).
“With a reputation for quality, compliance and reliable supply, Catalent’s invitation to present on new technologies to the FDA is a strong testament to our leading position as a drug delivery provider, with innovative solutions that address industry challenges and provide opportunities for better treatments,” commented Sharon Johnson, Catalent’s Senior Vice President, Quality & Regulatory Affairs. “Feedback from the FDA was very positive and Catalent looks forward to engaging in further discussion to drive awareness and support for our advanced delivery technologies.”
ADVASEPT Technology is a glass-free vial design that leverages proven Quality by Design manufacturing techniques to optimize the blow-fill-seal process. This form of advanced aseptic processing creates a next generation, glass-free vial that minimizes the risk of contamination through automation and process simplification. The process significantly reduces foreign particulates, process steps, and human intervention, which ultimately reduces some of the major risks associated with aseptic filling of injectable products into glass vials.
With more than 20 products launched in 50 countries, Zydis is the world’s best in class, orally disintegrating tablet (ODT) technology. Whether to advance pharmacokinetics through pre-gastric absorption, improve patient compliance, or adding marketing advantage to a valued brand, Catalent’s customers draw on Zydis fast dissolve technology to potentially enhance investment value and accelerate a product’s potential.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com