Newsletter | October 4, 2021

10.04.21 -- Will FDA Reclassify Your Drug Product As A Device?

 
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Featured Editorial
Industry Insights
Do Small Outsourcing Partners Benefit Small And Emerging Biotechs?

Large CRO partners tout expertise or experience based on past success. Pulling back the curtain on this “corporate memory” can reveal the inefficiency of “that’s the way it’s always been done” thinking.

Spray Drying Strategies: Development To Commercialization

The case studies presented in this paper highlight Thermo Fisher Scientific’s spray drying experience and our dedication to helping manufacturers overcome obstacles that could slow your path to market.

Drive Efficiency, Reduce Waste: Sustainable Chemistry Is Greener By Design

Conceived by the EPA more than 30 years ago, “Green Chemistry” was intended to prompt solutions to real-world environmental problems resulting from industrial processes, emissions, and waste.

Robust CHO Cell Expression Platform For High-Quality Biomanufacturing

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Addressing The Training Gap For Single-Use Technologies

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

Comparing Different Methods Of Clarification Of CHO Cells

In this study, alluvial filtration, depth filtration, and flocculant filtration have been evaluated, and data generated with these three methods at laboratory scale are discussed.

Confident Clonality: How To Make Your IND Approval A Reality

The Opto Cell Line Development workflow on the Beacon system has been demonstrated to provide >99% probability of clonality from a single automated round of cloning. Here's the three-part process.

Viral Quantification: AAV Vector Genome Titer Assay

Read how droplet digital PCR (ddPCR) represents a highly precise method to determine AAV vector genome titers and is not unduly influenced by inefficient amplification or standard curve issues.

How Outsourcing Buffer Prep Enables A COVID-19 Vaccine

As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecules on a global scale.

Address Biopharma's Evolving Information, Automation Needs

A dramatic increase in the information available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharma manufacturers operate. 

Developing A Closed Connected Single-Use mAb Purification Process

This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.

Transforming Your Bioanalytical Operations

A combination of controlled, compliant workflow execution and dramatically streamlined data acquisition is the next phase of innovation within bioanalysis.

Manufacturing Dry Powder Inhaled Formulations By Spray Drying

Kimberly Shepard, Ph.D., associate principal engineer in R&D, answers questions about how spray drying can address many challenges associated with late-stage lung cancer treatments.

Products And Services For mAb Upstream Development

When developing a monoclonal antibody with a world of potential, getting your upstream process development right the first time opens up exponential possibilities. 

Practical, Innovative Solutions For AAV Development, Manufacturing

Explore case studies for neuromuscular degenerative indications, AAV technology and manufacturing, and strategies for navigating the regulatory environments in the U.S. and Europe.

SUS Design For Cryogenic, Cold Temperature Operations

Cryogenic operations play a critical role in many processes. Join as Ross Acucena, applications director, discusses single-use system (SUS) design for cGMP cryogenic operations.

Challenges And Advantages Of Implementing N-1 Perfusion Technology

Discover key considerations and challenges in implementing N-1 perfusion technology as well as the impact of continuous technology on tech transfer and process scale-up.

Novel Uses For OSD Driving Lifecycle Management Strategies

With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.

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