Ensure first-time right GMP production of gene therapies: Proven strategies for pre-clinical manufacturing and early process development
Feb
2
2023
On demand

Ensure first-time right GMP production of gene therapies: Proven strategies for pre-clinical manufacturing and early process development

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET
Sponsor
Ensure first-time right GMP production of gene therapies: Proven strategies for pre-clinical manufacturing and early process development

Live30 webinars are thirty minute presentations designed to update you on the latest innovations, applications and data in a fast yet interactive format.

While the rigors of early process development (PD) and preclinical manufacturing in cell and gene therapy can appear daunting for young companies, prioritizing certain early studies, with quality pre-clinical material can mean the difference between success and failure for these highly sensitive drug products during clinical trials and commercial launch. 

Early investment in process characterization, stability, and formulation to understand an advanced therapy’s capacity for scale-up and patient administration is integral to maximizing its potential reach.

Attendees will learn:

  • How key early-stage studies can mitigate risk and prepare companies for successful regulatory submissions
  • How high-throughput capabilities are available to improve process productivity and scalability
  • Why Pilot Plant operations provide flexibility and training advantages for preclinical production
Avi Nandi
Avi Nandi
Chief Technical Officer, Centre for Breakthrough Medicines

Avi Nandi is the Chief Technical Officer at The Center for Breakthrough Medicines. He has 15+ years of industry experience in Gene Therapy, Viral Vectors, and Vaccines with a MS in Biology and MBA and has contributed to the regulatory approval of ZOLGENSMA in US and 10+ Rest of World markets.

Avi supported a pipeline of gene therapy products in development from preclinical to Phase III development and led development and implementation of 4 gene therapy manufacturing processes across 4 GMP and 3 laboratory sites.

He also has 10+ years experience in vaccine and viral vector development including, AAV, adenovirus, herpesvirus, alphavirus, lentivirus, and RNA. His past experiences include: AveXis / Novartis Gene Therapies – Head of Technical Development, Seqirus / CSL – Head of Virology and Cell Culture, Process and Product Development Lead, Novartis Vaccines and Diagnostics – Technical Development Scientist, R&D Microbial and Molecular Scientist Harvard Medical School – Viral Pathogenesis Scientist.

Tatiana Nanda PhD
Tatiana Nanda PhD
Sr. Director, Drug Product, Centre for Breakthrough Medicines

Tatiana Nanda has over 11 years of experience in biotherapeutics across mAbs and cell and gene therapies and is currently the Head of Cell and Gene Drug Product Development at the Center for Breakthrough Medicines.

In this role Tatiana is responsible for design and implementation of a diverse and client-focused Drug Product service portfolio and the establishment of internal formulation and manufacturing platforms. Prior to joining CBM, she was in Janssen, where she led the DP scientific strategy and execution of Oncology and Ocular compounds across multiple modalities including autologous CAR-T’s and AAV gene therapies. 

She was also involved in the startup of J&J’s commercial LVV manufacturing facility in Raritan, NJ. Prior to this, Tatiana worked at GSK in Biopharmaceutical Product Sciences. Tatiana has a BS in Microbiology from the University of Tennessee, a MS in Economics from the Moscow State University, and a PhD in Biophysics & Lifesciences from UT/ORNL.

SPEAKERS

Avi Nandi
Avi Nandi
Chief Technical Officer, Centre for Breakthrough Medicines
Tatiana Nanda PhD
Tatiana Nanda PhD
Sr. Director, Drug Product, Centre for Breakthrough Medicines