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Latest Content

Cell therapy CMC and quality control

C Niederlaender
Christiane Niederlaender
Vice President Technical at Parexel
Christiane Niederlaender. has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. In that capacity she chaired and oversaw all formal scientific advice meetings and had in-depth involvement of Brexit preparedness. At the same time Christiane was a Senior Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). She was UK CAT Rapporteur responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline and quality lead for gene therapy section of new draft guideline for investigational ATMPs. She was a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector. Christiane has experience in CMC and regulatory strategy for all types of biological products, with a particular focus on gene and cell therapies, novel biotherapeutics, biosimilars and vectored vaccines. While at MHRA, she was the principal quality/CMC assessor for 10 centralized MAAs, including two full dossier applications for ATMPs as sole UK quality assessor (including CAR-T, see publications). She has in depth knowledge of all European procedure types, both centralized and MR/DCP, and can give advice on ATMP classification, ODD and the PRIME program. As an ex-member of the EMA CAT committee, Christiane is familiar with the thinking of all European regulators in the ATMP space and is used to dialogue and negotiation with many regulatory agencies, as well as presenting her thinking during committee discussions. Christiane undertook her undergraduate studies in biochemistry, neurobiology and molecular biology at Heidelberg University in Germany before obtaining her PhD in molecular developmental neurobiology at Kings College London in the UK. Christiane has published her academic research in many high impact journals, including Nature.
14 May 2021
Foreword

The Corning® Ascent™ Fixed Bed Reactor (FBR) System: Designed...

Z Melkoumian
Zara Melkoumian
Senior Technology Manager, Corning Research and Development Corporation
Zara holds a PhD in Pharmacology and Toxicology and has 15 years of industry experience in bringing innovative cell culture products and technologies to market. Prior to joining Corning, Zara was a post-doctoral fellow at Cornell University where she studied the mechanism of action of a novel tumor suppressor gene in human breast cancer cells.
29 April 2021
FastFacts

Simplifying AAV protein analytics with Maurice

C Heger
Chris Heger PhD
Director, Applications Science
Chris Heger, Senior Manager of Applications Science for the Analytical Solutions Division of Bio-Techne, leads a team chartered with creating scientific collateral, fostering collaborations, training, and coming up with new applications. Chris has expertise in immunoassays, capillary electrophoresis, antibody design and production, and chromatography. In recent years, his team has focused on developing analytical solutions for cell and gene therapy researchers.Chris received his doctoral degree in Pharmacology from Cornell University and completed his post-doctoral training at the National Cancer Institute. Working in the Antibody and Protein Purification Unit, Chris oversaw antibody development projects, from immunogen design to final product. A unique aspect of his postdoctoral training was his role in the evaluation of new technologies, serving as the gateway for cutting edge instrumentation to get into use at the NCI/NIH. Through this role, Chris became well-acquainted with ProteinSimple and after completing his postdoctoral training, began working for ProteinSimple (now part of Bio-Techne).
29 April 2021
FastFacts

A demonstration of the Cocoon® platform: a bespoke solution...

J O’Connor
Joseph O’Connor
Senior Scientist, Personalized Medicine Business Unit, Lonza
Joseph O’Connor, PhD, is currently a senior scientist in process development for Lonza’s Personalized Medicine Business Unit. His focus is on translating and optimizing manual autologous cell therapies into the Cocoon® Platform, a closed and automated cell therapy manufacturing solution. Joseph earned a doctorate in chemical engineering from the Pennsylvania State University while researching the mechanical regulation of gene expression. He has been with Lonza since 2017.
21 April 2021
FastFacts

Fitting product to process: raw materials customization...

L Belcastro,
Lili Belcastro
Scientist, Biotherapeutics Material Sciences at Janssen
Lili Belcastro is a Scientist at Janssen and is responsible for the qualification of raw materials used in Janssen’s cell and gene therapy products. Dr Belcastro has over 10 years of experience in preclinical and clinical cancer biology, cell and gene therapy product development, and analytical method development. Prior to joining Janssen in 2017, she was finishing her PhD in cancer biology in a joint program with the University of the Sciences and The Wistar Institute in Philadelphia. Prior to joining industry, Dr. Belcastro led pediatric, preclinical, in vivo testing programs at the Children’s Hospital of Philadelphia for small molecule inhibitors, oncolytic viruses, antibody-drug conjugates, and radiopharmaceuticals. Dr. Belcastro holds two bachelor’s degrees from Temple University and the University of the Sciences.
M Brabec,
Mitchell Brabec
Commercial Development Specialist at Bio-techne
Since 2015, Mitch has filled multiple roles within Bio-Techne prior to joining the Commercial Development group. He began in Technical Support to support Research Use Only (RUO) and Good Manufacturing Practices (GMP) products for academic and industrial clients, followed by Product Marketing in the Protein Business Unit for RUO and GMP proteins. As a Commercial Development Specialist with the Custom Projects team, he helps clients find solutions for their workflows by managing GMP conversion, custom protein modifications and GMP fill-finish projects. Mitch works closely with Bio-Techne’s development scientists and expert quality and regulatory groups.
L Clarke et al.
Lindsey Clarke
Global Product Marketing & Commercial Strategy, Cell & Gene Therapy at Bio-techne
Lindsey has spent the last decade working in Cell and Gene Therapy on the raw materials supplier side prior to running Bio-Techne’s Global Cell and Gene Therapy Product Marketing team. She joined Bio-Techne in 2018 to establish their European Cell and Gene Therapy specialist team and has recently transitioned into a global role. She is focused on building the team to support customers applications, planning the roll out of new innovations, and developing strategic partnerships within the industry. Prior to this she was in Miltenyi Biotec’s UK field team, working closely with numerous process development and manufacturing teams to assist in translating their varied cell therapies to the clinic. Lindsey holds a first-class degree in Pharmacology from the University of Bath, a PhD in Immunology from UCL and worked as a postdoctoral scientist at Imperial College before moving into more commercial roles.
22 March 2021
Innovator Insight

Preclinical/translational tools & strategies

B Bunnell
Bruce A Bunnell
Professor and Chair, Department of Microbiology, Immunology and Genetics, University if North Texas Health Science Center, Fort Worth, TX, USA 76107
Bruce A Bunnell is a professor and Chair of the Department of Microbiology, Immunology and Genetics at the University of North Texas Health Science Center in Fort Worth, TX. Previously, he served as Director of the Tulane Center for Stem Cell Research and Regenerative Medicine and Professor in the Department of Pharmacology in the Tulane University School of Medicine. Dr. Bunnell obtained his PhD in Microbiology from the University of Alabama at Birmingham School of Medicine. He then pursued Postdoctoral Fellowship research at the Howard Hughes Medical Institute in the School of Medicine at the University of Michigan and the National Human Genome Research Institute at the National Institutes of Health in Bethesda, MD. Dr. Bunnell was an Assistant Professor at the Nationwide Children’s Hospital Research Institute, part of the Ohio State University School of Medicine prior to joining the faculty at Tulane University in 2002. Dr. Bunnell’s research program is focused on both the basic science and translational applications of adult stem cells isolated from the bone marrow and adipose tissue. Dr. Bunnell investigates use of mesenchymal stem cells (MSCs) isolated from the bone marrow or adipose tissue as a therapeutic intervention for both multiple sclerosis (MS) wound repair, lung injury and bone repair. He is particularly interested the interactions of MSC with the immune system and how the cells elicit robust anti-inflammatory effects in vivo. He is currently working towards a human clinical trials for the treatment of osteoarthritis, traumatic brain injury and MS with these cells. He has served as a reviewer of stem cell, regenerative medicine and tissue engineering grants for the National Institutes of Health, Department of Defense and several state funded programs including Maryland, New York, Virginia and Pennsylvania. He has also served on grant review panels for several foreign countries including Denmark, Ireland, Poland, Germany and Spain. Dr. Bunnell serves as an Editorial Board Member for several journals, including Stem Cells, BMC Genomics, and Regenerative Medicine.
24 February 2021
Foreword