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  4.  » Catalent Biologics and Humanigen to Present a Case Study on Accelerated Scale Up of a Monoclonal Antibody to Treat COVID-19 at BioProcess International Conference

Catalent Biologics and Humanigen to Present a Case Study on Accelerated Scale Up of a Monoclonal Antibody to Treat COVID-19 at BioProcess International Conference

SOMERSET, N.J. – September 16, 2020 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it will present at the upcoming BioProcess International virtual conference, taking place between Sept. 21 – 25, 2020.

The COVID-19 pandemic has seen innovators looking to accelerate timelines in order to bring safe and effective potential therapies to patients quickly. During the conference’s “Manufacturing Strategy & Bioprocessing 4.0” session track, on Wednesday, Sept. 23 at 3:40 p.m. EDT, Melanie Lasher, Manager, Project Management, Catalent Biologics, and Cameron Durrant, M.D., MBA, Chairman and Chief Executive Officer, Humanigen, will jointly present a case study on the investigational monoclonal antibody, lenzilumab, and its development from gene to late stage clinical trials. During their presentation, titled “Accelerating Manufacturing for Investigational COVID-19 Therapeutic Candidate Lenzilumab to Prevent and Treat Cytokine Storm”, Ms. Lasher and Dr. Durrant will discuss how Catalent Biologics and Humanigen have collaborated to address the challenge of manufacturing scale-up to bring lenzilumab to patients as quickly as possible. A Phase 3 study is currently underway evaluating hospitalized patients with COVID-19.

Ms. Lasher has more than 10 years’ experience in the biopharma industry. She has managed a variety of clinical, process and performance qualification, and commercial projects, supporting drug substance manufacturing, drug product filing, and packaging. Ms. Lasher is the program management lead for Catalent’s OneBio® Suite, an integrated solution for the development, manufacturing and supply of biologic drugs, designed to accelerate timelines, reduce risk and simplify the process for sponsor companies looking to bring their biologic to clinic and market. Ms. Lasher received a bachelor’s degree from Indiana Wesleyan University, Marion, Indiana, and is a certified Project Management Professional.

Dr. Durrant is an entrepreneur, board member, C-level executive, former big pharma executive and a medical doctor by original training. He is a prior regional winner of the Ernst and Young ‘Entrepreneur of the Year’ award, named in the PharmaVoice 2005, 2006, 2007 and 2010 list of one of the ‘100 most inspiring people in the pharmaceutical industry’. Dr. Durrant earned his medical degree from the Welsh National School of Medicine, Cardiff, U.K., and holds a Diploma of the Royal College of Obstetricians and Gynaecologists, London, U.K., as well as being a Member of the Royal College of General Practitioners, London. He also holds a DipCH from the Melbourne Academy, Australia and a Master of Business Administration from Henley Management College, Oxford, U.K.

About Catalent Biologics

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors, lentiviral vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. When Catalent acquired MaSTherCell, it added expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has worked with industry-leading partners across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com

ABOUT CATALENT

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, 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 global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

 

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