Gibco Galaxy Tour 2020

Kasey Kime
Senior Manager, Regulatory Affairs Clinical and Compliance
Life Science Solutions, Thermo Fisher Scientific

Michael Brewer
Director, Global Principal Consultant, Regulatory
BioProduction, Thermo Fisher Scientific

Abstract

The emergence of new therapeutic modalities has created novel challenges for manufacturers and meeting these challenges requires innovative solutions to meet the regulatory expectations specific to these products. Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to attack cancer cells. Gene Therapy, which is the transplantation of normal genes into cells in place of missing or defective ones in order to correct genetic disorders, often utilizing recombinant viral vectors. Although every therapy and process are different, there are a few key decisions that are critical to the success of any advanced therapy medicinal product (ATMP) and for the success of the company that plans to bring them to the clinic.

In this webinar, we will discuss two key areas to consider when you’re preparing to commercialize a cell or gene therapy product:

• Starting/raw material – the components you choose at discovery can ultimately define the success of your development and GMP manufacturing process. We’ll highlight some key watch outs and what to ensure is being provided by your suppliers.
• Quality and Safety Testing – ATMPs have clear quality control tests that must be performed throughout the manufacturing process and product release, we’ll review essential tests that are required for lot release and regulatory filing and present solutions that save time and are accepted by regulators for lot release testing.

What you'll learn:

• Regulatory requirements for GMP ancillary materials for cell and gene therapy
• Characterization and lot release testing solutions and validation strategy for regulatory CMC filing

Who should attend:

Process Development scientists
Cell Culture Development scientists
Analytical development scientists
QC specialists
R&D/Preclinical researchers
CMO/CDMO

Dr. Premkumar Jayaraman,
Regional Field Applications Scientist, Cell and Gene Therapy
Asia Pacific & Japan, Thermo Fisher Scientific

Abstract

Recent regulatory approvals of the world’s first Chimeric Antigen Receptor T cell therapy and Adeno-Associated Virus (AAV)-mediated gene therapy offers patients more promise than ever for curative effects. However, many technical challenges remain in the manufacturing process. Dr Premkumar Jayaraman will give an overview of the Gibco CTS workflow solutions and how they offer a seamless transition from research to commercialization by providing scalable technologies manufactured under cGMP with extensive safety testing, unified traceability documentation, and experienced consultation.

Dr Premkumar Jayaraman will also discuss viral and non-viral delivery approaches used in the genetic engineering of cell and gene therapy applications. He will speak on applications of innovative technologies such as the CTS LV-MAX™ lentiviral production system and next-generation CRISPR Cas9 protein engineered to deliver maximum editing efficiency.

Dr. Ryan Lim
Regional Field Applications Scientist, Immunoassays and Immunotherapy
Asia Pacific & Japan, Thermo Fisher Scientific

Abstract

Today’s cell and gene therapy manufacturers are transforming lives by making better therapies more accessible. As a result, ensuring the purity, potency and safety of these therapies is paramount. Dr Ryan Lim will give an overview of the current trends, next generation technologies, and reproducible, cost-effective methods to ensure that cell and gene therapy products are safe for release.

Dr Ryan Lim will also highlight the critical need use next generation multiplex immunoassays for potency testing and introduce highly sensitive and efficient assays for human residual DNA quantification, endotoxin and mycoplasma testing.

Mary Kay Bates
Senior Global Cell Culture Scientist
Thermo Fisher Scientific 

James Tan
Regional Product Manager
Southeast Asia & Taiwan, Thermo Fisher Scientific  

Abstract

Cell and gene therapy applications are projected to continue a global growth trajectory of more than 20% through 2024. Every year, more advances lead to new startup companies and partnerships. As you transition your discovery through research and development to commercial production in a GMP setting, your goal is to speed that process by minimizing variables. Laboratory equipment with remote monitoring capabilities plays a key role in that process and should offer proven solutions.

This talk will:

• Review the growth of regenerative medicine globally
• Provide an overview of GMP work and how it differs from basic research and development
• Explore the important ways that laboratory equipment can ease the transition including composition materials, factory acceptance testing, cleaning and maintenance, and factory trained support.
• Demonstrate the role that remote monitoring take towards support Cell & Gene Therapy set-up in a GMP setting.

Jacqueline Ng
Regional Manager, Cell and Gene Therapy
Asia Pacific & Japan, Thermo Fisher Scientific

Abstract

Manual processes commonly used in development and clinical trials are not cost-effective, transferable, or commercially viable. Alternative methods using more integrated systems often lack flexibility and generally suffer from poor capacity utilization. To accelerate the manufacturing of cell and gene therapies, the industry requires a novel approach.

Jacqueline will introduce the Gibco Rotea CTS counterflow centrifugation system which is a closed, modular, automated system designed to enable scalable and cost-effective manufacturing of cell and gene therapies. Gibco™ CTS™ Rotea™ is designed for separation, washing and concentration of both autologous and small-scale allogeneic cell therapy samples. It utilizes counterflow centrifugation to achieve remarkably low output volumes and greater than 95% cell recovery and viability. This novel technology will enable its users to move faster and seamlessly transition from research to clinical and commercial cGMP manufacturing on the same instrument.

Jasmin Tseng
Product Manager
Southeast Asia & Taiwan, Thermo Fisher Scientific

Abstract

Manual processes commonly used in development and clinical trials are not cost-effective, transferable, or commercially viable. Alternative methods using more integrated systems often lack flexibility and generally suffer from poor capacity utilization. To accelerate the manufacturing of cell and gene therapies, the industry requires a novel approach.

Jasmin will introduce the Gibco Rotea CTS counterflow centrifugation system which is a closed, modular, automated system designed to enable scalable and cost-effective manufacturing of cell and gene therapies. Gibco™ CTS™ Rotea™ is designed for separation, washing and concentration of both autologous and small-scale allogeneic cell therapy samples. It utilizes counterflow centrifugation to achieve remarkably low output volumes and greater than 95% cell recovery and viability. This novel technology will enable its users to move faster and seamlessly transition from research to clinical and commercial cGMP manufacturing on the same instrument.