Newsletter | March 21, 2025

03.21.25 -- BoB@JPM: Tom Chalberg, Ph.D., Genascence

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Webinar: Adapting to Evolving Regulations: Validation in a Changing Landscape

Join a roundtable with Kneat experts to explore evolving regulatory expectations in the life sciences industry. Learn about key regulatory requirements, the shift to risk-based approaches like Computer Software Assurance (CSA), and how digital validation can improve compliance, efficiency, and audit readiness. Gain actionable insights and strategies for navigating Pharma 5.0. Click here to learn more.

FOCUS ON REGULATORY

BoB@JPM: Tom Chalberg, Ph.D., Genascence

This episode of the Business of Biotech finds Matt Pillar and Ben Comer exploring the evolution of gene therapy with Dr. Tom Chalberg, Founder, Chairman, and CEO at Genascence. Listen in as they discuss ATMPS' transition from treating rare diseases to addressing common conditions like osteoarthritis, share insights on the delivery mechanism and regulatory challenges in the space, and get into the nuts and bolts of the Genascence partnership strategy.

The Advantages Of A Blended Learning Approach In Operator Training

Consider blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.

The Aqueous Cleaning Handbook: Measuring Cleanliness

Gain insight into proper cleanliness detection, contact-angle measuring methods, the water drop surface energy test, and in-situ particle monitoring.

Contamination Control Strategy With QRM Principles

Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

5 Steps To Implementing CSA

Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.

REGULATORY SOLUTIONS

Single-Use Strategies For Uninterrupted Microbial Monitoring - Particle Measuring Systems

On- And Off-Target Gene Editing Assessment Services - MaxCyte, Inc.

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The rapid advance of ADCs has tested the fine balance between speed to IND and process development that stands up to the rigors of scale-up and transfer. Explore the processes leading ADC developers are employing to mitigate manufacturing-scale risk, and how automation and artificial intelligence are beginning to inform their work. Join Bioprocess Online Live for this interactive discussion. Registration is free thanks to the support of Thermo Fisher Scientific.

FOCUS ON QUALITY/ANALYTICAL METHODS

Industry Leaders On Analytical Method Development

Experts from Bristol Myers Squibb and Moffitt Cancer Center discuss best practices for analytical method development, as well as how to manage the successful transfer of these methods.

Product Transition Guide: Legacy Protein A Resins To Praesto AP+80

Streamline mAb production and cut costs with advanced chromatography resins. This guide explores transitioning to high-efficiency options, comparing performance and key factors for seamless integration.

Demonstrating Technical Excellence In Contract Manufacturing

Tech Talks delves into ADC development innovations, including integrated supply chains, seamless pilot-to-GMP scale-ups, and advanced process analytical technology (PAT).

Automated Setup On BD FACSLyric Flow Cytometer Streamlines Workflow

Examine the usability and performance capabilities of a system that provides a streamlined flow cytometry workflow, from instrument initialization to data acquisition and analysis.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

Validating The Efficacy Of A Compound With Spatial Imaging

Discover how target and efficacy validation can translate into substantial savings and market advantages for sponsors as a result of shortened development and approval timelines.

Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis

Here, we look at advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.

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Webinar: Navigating Global Regulatory Landscapes in an Evolving Biopharma Industry

This webinar offers insights into managing raw material changes and navigating regulatory challenges in the biopharma industry. Experts will discuss collaboration between suppliers and users, risk management, change management, and adapting to evolving regulations. Key objectives include mastering regulatory guidance, implementing effective change management, and understanding market trends. Join us to explore best practices and remain compliant throughout drug development. Click here to learn more.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Accelerate Cross Site Collaboration With Simple Assay Transfer - BD Biosciences

Analytical Methods - Mycenax

Tackle Your Most Challenging Affinity Screenings With Breakthrough Spectral Shift Technology - NanoTemper Technologies, Inc.

Vericheck ddPCR Empty-Full Capsid Kits - Bio-Rad Laboratories, Inc.

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