Newsletter | June 29, 2022

06.29.22 -- FDA Guidance For Biopharma Container Labels & Carton Labeling Design

 
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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.

Implementing Global Supply Risk Mitigation Through Multisourcing

Multisourcing and other raw material and platform strategies contribute to a reliable supply for patient medications by deftly managing on-the-fly change within client processes.

Unprecedented Growth — And Challenges — In Gene Therapy

The gene therapy clinical pipeline is in a high growth phase, with an influx of venture capital funding. There are also challenges: scalability, dosing, and the price of the final treatment.

Developmental Testing Of IV Solutions

As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

Telltale Signs You’re With The Wrong CDMO

Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your partner isn't carrying its weight on your journey to commercialization.

The Evolution Of Single-Use Systems And The Emergence Of Unmet Needs

The bioprocess boom of 2020, which continues unabated, has attracted many players into this space. More and more integrators are entering the market, one that's far from easy to master.

How Effective Training Management Can Help You Prevent Quality Issues

Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.

Seed Train Intensification Using High Cell Density Cryopreservation

High cell density cryopreservation, a perfused seed train, and specially designed expansion medium can create shorter lead times, reduce plant footprints, increase flexibility, and reduce cost of goods.

Purifier Performance In mAb Mammalian Cell Cultures

The 3M Emphaze AEX Hybrid Purifier is designed to reduce DNA, HCP, endotoxin, and cell debris. Here we review its performance and benefits in a typical monoclonal antibody purification process. 

PTFE Containment: Viable For Temperature-Sensitive Protection

Single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage at cold temperatures.

Controlling Host Cell Proteins In Drug Development

Explore methods to detect HCPs and how to reduce the risk of unexpected HCPs and maximize the efficiency of your HCP management strategy.

Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up

Process data are used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale-up.

Optimized Protein A Resin To Minimize Elution Buffer Selection Impact

The impact of the elution buffer counter-ion, pH, and molarity were evaluated on the key purification performance parameters of Amsphere A3. In total, five different mAbs were used for the study.

Developing A Novel Approach To Real-Time Monitoring Of Antibody Titer

As the industry continues to apply innovative manufacturing tools and solutions, it also needs real-time monitoring to keep up with a modern production suite. 

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