Catalent to Launch OneBio Suite for Integrated Biologics Development, Manufacturing & Supply
Catalent (Booth 3101) recently announced it will launch its new OneBio Suite for the integrated development, manufacturing, and clinical supply of biologic drugs at the BIO International Convention, which takes place at the Pennsylvania Convention Center in Philadelphia, from June 3-6, 2019.
OneBio has been designed specifically to address the challenges facing biologic development companies that are looking to accelerate programs to clinic or market, or that require greater simplicity in the development process, including fewer internal resource needs and a reduced risk of rework. As a single, integrated provider, Catalent Biologics’ OneBio Suite will aim to reduce timelines, risk and complexity by providing customers with a single contract, program manager, and development timeline from cell line to clinical supply with harmonized quality systems. The OneBio Suite draws upon Catalent’s proven track record of progressing biologic drugs to market, which includes over 115 global clinical trials and 11 commercially marketed monoclonal antibodies using the company’s GPEx cell line development technology, and 20 approved products through fill/finish and commercial supply to global markets.
“Time is often lost for sponsors on the path to clinic from contract negotiation, site inspections, handoffs, and poor communication between multiple vendors,” commented Bernie Clark, Vice President, Marketing & Strategy, Catalent Biologics & Specialty Drug Delivery. “Through our new OneBio Suite, Catalent is uniquely positioned to provide an integrated offering that can accelerate biologic development potentially shaving weeks to months off standard timelines and allowing our customers to get to clinic and market faster.”
Additionally, at the BIO Convention, Steven Hager, PhD, Senior Director, Technical Support, will present Cell Line Development Strategies for Difficult to Express Proteins as part of the Emerging Techniques, Technologies and Strategies track. His presentation takes place on Wednesday, June 5 from 11:40 a.m.-12:00 p.m. at the BPI Theater, Booth #3211 in the BioProcess Zone.
On the same day, from 1:45 – 2:30 p.m., Dr. Hager will also participate in a ‘Single Use Systems Versus Stainless Steel’ roundtable, also at the BPI Theater.
Catalent Biologics provides advanced technologies and integrated solutions for biologic and biosimilar development and manufacturing, from DNA to fill/finish and commercial supply, through its extensive Biologics network including: Bloomington, Indiana, where the company recently announced a twentieth commercial launch of a fill/finish product, and; Madison, Wisconsin, home of Catalent Biologics’ proprietary GPEx technology for stable, high-yielding mammalian cell lines with eleven approved molecules. For more information on Catalent Biologics, visit biologics.catalent.com.
Catalent Biologics has 20+ years’ experience in development, manufacturing, and analytical services for new biological entities, biosimilars, and antibody-drug conjugates. Catalent has worked with 600+ mAbs and 80+ proteins, and more than 115 clinical trials and 11 marketed products have used GPEx cell line engineering technology. A further 20 commercially-approved products have employed Catalent Biologics’ capabilities through to aseptic fill/finish. Using advanced protein improvement technology and tailored solutions from DNA through to clinical and commercial supply, Catalent Biologics brings better biologic treatments to patients, faster. For more information, visit biologics.catalent.com.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 85 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 over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com.
Total Page Views: 631