Newsletter | September 28, 2022

09.28.22 -- CAR-T & Beyond: CGTs In Development In 2022

Featured Editorial
Industry Insights
8 Misconceptions On Collaborating To Benefit Your Drug Program

Review a few misconceptions about collaborating with Pfizer CentreOne and how they align with the values of courage, excellence, equity, and joy.

Understanding The Cold Durability Performance Of Fluoropolymer Bags

Although polymer bags are an excellent choice for cold chain use, not all polymer films perform the same way, even if their specifications rate them for use at low temperatures.

Meeting Stability Testing Expectations In A Complex Biopharma Landscape

What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.

Increasing Productivity In Hydrophobic Interaction Chromatography

In this study, the hydrophobicities of newer-generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

Overcoming Challenges In Spray-Dried Biologics

Kimberly Shepard, Ph.D., principal engineer in R&D, addresses the challenges associated with spray drying late-stage lung cancer treatments, including proteins, peptides, and mAbs.

Utilizing Expertise And Experience In Downstream Processing

Working with a CDMO that can impart extensive expertise to the numerous methods of downstream drug substance manufacturing ultimately can help you achieve the most positive outcomes for your process.

Continuous Biomanufacturing: N-1 Technology For Higher Productivity, Quality

Among the numerous benefits of N-1 technology-backed CM are reduced bioreactor size, standardized sizes, a simplified process, and the potential to utilize single-use bioreactors (SUBs).

The Supply Chain Executive’s Perspective On Single-Supplier CDMOs

A single vendor offers access to a network of experts who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. 

How To Build A Robust Packaging Strategy For Rapid Commercialization

Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

Bridging The Gap Between Drug Substance And Drug Product

It can often feel as if the drug substance group simply passes the drug substance across a fence to the drug product group for further processing without any real communication.

Addressing The Training Gap For Single-Use Technologies

This article reviews how a blended training approach of face-to-face, e-learning, virtual classrooms, virtual reality, and mixed reality training is the best way to achieve training goals.

Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

Researchers using analytical power tools can reach their goals faster and shorten the bench-to-bedside development path, benefiting both patients and the bottom line.

Secondary Packaging Strategies For Commercial Launch Of A Biologic

A commercial packaging solution can be the first and enduring impression that a sponsor company makes on a patient, and its suitability can impact a biologic’s commercial success.

Is Your Biologic At Risk For Protein Aggregation? Part 3

The main culprit of a failing biologic drug is usually a flawed formulation. In this article, we cover formulation components and how they may affect protein aggregation. Part three of a three-part series.

Supply Chain Security: Focus On Raw Material Variability

Qualifying two suppliers, increasing capacity, implementing a supplier scorecard, and surveying suppliers' number of production lines can help guarantee supply — but close attention must be paid to raw materials.

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