Search

Deploying Modeling & Simulation to Enable Advanced Process Monitoring & Control

Johannes Scheiblauer at Takeda and Sean Bermingham at Siemens

Presented by Johannes Scheiblauer, Associate Scientific Fellow for Digital CMC at Takeda and Sean Bermingham, Head of Formulated Products at Siemens ...

2 weeks ago 112 mins

Platform Technology To Speed Up CMC Process

Dr H. Fai Poon, President, QuaCell Biotech Ltd

The commercial success of monoclonal antibodies has made biologics become attractive to pharmaceutical companies . The approval pathway is often requi...

7 months ago 32 mins

The Use of AI and ML in Pharmaceutical Manufacturing...

Dr. Gert Thurau, Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Roche

Full title: The use of AI and ML in pharmaceutical manufacturing - the evolving regulatory environment in the GMP and CMC Reg space in the US and Euro...

January 17, 2024 2:30pm

CMC Progression from Early to Late Phase...

Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest

Full Title: CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy The principles for developing traditional biologics ...

2 years ago 88 mins

Operational Excellence in Process Development in Drug Substance Production

Presented by Ken Green, Ph.D, Head of MSAT at Samsung Biologics and Klaus Mauch, CEO at Insilico Biotechnology AG

This presentation will highlight Samsung Biologics (SBL) approach to align process development activities with technology transfer and cGMP manufactur...

3 years ago 107 mins

New-Drug Development: Succeeding With the FDA

Premier Research

Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s...

10 months ago 43 mins

How to Utilize Design of Experiments (DoE) Principles for the Development of...

Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca

Full Title: How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product...

3 years ago 43 mins

Facilitating CMC Development and Regulatory Filings with Phase-Appropriate QbD

Tiffany Rau, PhD, Rau Consulting LLC, Phil Ramsey, PhD, Predictum Inc., and Wayne Levin, Predictum Inc.

Pharmaceutical and biotechnology companies are under increasing pressure to reduce timelines and costs to speed up the delivery of safe and high-quali...

3 years ago 54 mins

A Successful Journey to Cell Therapy Manufacturing: From R&D to Lot-Release

Kasey Kime, Sean Chang, Uma Lakshmipathy

Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to atta...

2 years ago 45 mins

Successful On-Boarding: Employee Retention Starts on Day 1

Jennifer Leake CMC, Founder, Assessment Pros LLC

Every new employee is asked "How was your first day?" when they arrive home after starting a new job. How do your new employees answer that question?...

5 years ago 33 mins

Search results