Newsletter | February 28, 2025

02.28.25 -- For Gilead, Sustainability Is More Than A PR Effort

NEW PODCAST EPISODE

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

Join Business of Biotech’s Matt Pillar and Ben Comer as they dive into the future of gene therapy with Dr. Tom Chalberg, CEO of Genascence. The discussion explores the shift from rare disease treatments to common conditions like osteoarthritis, the challenges of delivery and regulation, and Genascence’s partnership strategy. Tune in for an insightful look at the changing landscape of ATMPS!

FOCUS ON SUPPLY CHAIN

Strengthening The Pharmaceutical Supply Chain For Single-Use Assemblies

Dual sourcing strengthens the pharmaceutical supply chain for single-use assemblies. Learn how this strategy and multi-sourcing can enhance resilience and adaptability in the face of disruptions.

Preventing Gas Ingress In Single-Layer Fluoropolymer Bags

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.

A Step-By-Step Guide To Cell Banking

Cell banking stands at the forefront of medical advancement. This guide delves into the steps involved in protecting these priceless resources, from cell collection and processing to storage and cell expansion.

Supplier Quality Is Only As Strong As Your Weakest Link

Your supply chain is only as strong as its weakest link. 52% of organizations attribute recalls to supplier-related issues, and proactive supplier quality management is essential to protect your brand.

The Importance Of Quality In Raw Material Selection

Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

FOCUS ON PROCESS ENGINEERING

For Gilead, Sustainability Is More Than A PR Effort

Gilead's chief sustainability officer and SVP of operations, Joydeep Ganguly, explains the company's cultural focus on sustainability and how it influences everything from R&D to manufacturing. 

How To Prevent Protein Aggregation Through Stabilizers And Surfactants

Learn about protein aggregation mechanisms, the role of excipients in stabilization, and novel surfactants that prevent aggregation in therapeutic protein formulations in this webinar.

Evaluating A Xeno-Free Serum Replacement Media Supplementation

This study compares the impact of a specific Human Growth Factor Concentrate (hGFC) and fetal bovine serum (FBS) on the growth, expansion, and viability of MSCs.

Charting A Successful CMC Journey For Your ADC Drug Product

Learn about best practices and strategies to optimize bioconjugate drug product tech transfers and supplies in clinical or commercial phase, and explore real-world case studies.

Cell Line And Process Development Workflows For A Streamlined Path To FIH

In this Q&A, KBI Biopharma process development experts discuss how advanced cell line development and transposase technology streamline the path to toxicology and first-in-human studies.

Optimizing Poloxamer 188

Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.

Building A Broad Oncology Portfolio With SOTIO CEO Dr. Radek Špíšek

Establishing an organization that can manage a diverse development pipeline for oncology therapies requires an equally diverse wealth of expertise.

A Focus On Cell Therapy: CAR-T, CAR-NK, And Beyond

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

Improve Scalability And Manufacturability Of A Cytotoxic ADC

Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

Super Short Activated CAR-T Process

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

Enhancing Yield And Quality In Bispecific Antibody Production

When it comes to bispecific antibody (BsAb) manufacturing, a well-optimized culture environment is essential for achieving high and consistent BsAb yields with the desired critical quality attributes.

High Yield Protein Production System For Suspension CHO Cells

Reduced the risk of contamination caused by repeated handling of the culture during transient protein production in suspension CHO cells.

Optimizing Scale-Up Of AAV Gene Therapy In Upstream Processing

Explore more detail on how to achieve a 2000L scale-up and studies that have been optimized through process characterization and experimental approaches to better understand key process steps.

N-Glycan Characterization With LC-MS

Glycosylation, a prevalent modification of mAbs, significantly impacts their function. Delve into various techniques for analyzing released glycans and their relative efficacy in HILIC-FLR-MS.

CHOp Your Protein Production Timelines

How can you leverage flow electroporation technology to drive your biologics development forward and deliver gram-scale transient protein production within two weeks?

Process Development For Lyophilized Products

Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

Overcome The Challenges Of Designing A QC Program For New Modalities

Stringent QC release testing throughout biologic production, as mandated by health authorities, ensures product safety and quality through evaluations of identity, purity, potency, and critical quality attributes.

The Value Of Tailoring Transposons For Optimized Biotherapeutic Production

By leveraging transposase-mediated technologies together with transposon design to achieve semi-targeted integration, drug developers can more efficient and consistent biotherapeutic protein production.

Identifying The Right Analytical Strategy For AAV Production

AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.

PROCESS ENGINEERING SOLUTIONS

PIC/S GMP Production - Mycenax

Tools For Developing Successful Biologics: XS Pichia Expression System - Lonza

Nano-ZL-IX5 Series - Mad City Labs, Inc.

Microcalorimeters For In-Depth Characterization - TA Instruments

Connect With Bioprocess Online: