Newsletter | April 14, 2021

04.14.21 -- Your Drug Development Team Holds The Key To The Clinic

 
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Is Your Biologics At Risk For Protein Aggregation? Part 1

This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.

Optimizing CDMO Tech Transfer

Many of the logistical, cost, and technical challenges associated with tech transfers can be overcome when the transfer takes place under one roof or occurs between near-identical facilities.

COVID-19's Impact On Outsourced Manufacturing

The immediate need for billions of doses of a vaccine sent tidal waves through the biopharma industry, derailed strategic plans, and forced pharmaceutical companies to shift resources.

Innovation And Flexibility During The COVID-19 Pandemic

Learn how one CDMO embraced the challenge to develop new diagnostic tests, treatments, and vaccines as they collaborated with customers to develop and manufacture new molecules.

Analytical Instrumentation: Advancing A CDMO’s Capabilities

To serve client needs as pharma tech advances, a CDMO must know when to acquire new tech, increase overall instrument capacity, and maintain existing validated instrumentation.

Flow Chemistry: Scale-Up Solution For Modern API Manufacturing

Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

Considerations For Upstream Biologics Development

A biologics candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.

Scalable Production Of Adeno-Associated Virus (AAV) Vectors

Explore some currently available schemes used in generating recombinant adeno-associated virus (rAAV) from suspension cultures and describes what it takes to achieve scalable rAAV production.

Precision Powder In Capsule Microdosing Accelerates Development

This paper describes the use of precision microdosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.

Buffer Management Strategies For Downstream Process Improvement

Understanding the buffer management alternatives and the resources needed to execute them helps ensure you have the tools necessary to remain competitive in today’s growing bioprocessing industry.

How To Prepare For Future Viral Vector Manufacturing

Rethinking how we transition from what has historically been carried out in translational clinical centers at smaller scale, using flasks and open systems, toward commercial production and methodologies.

A Tale Of Two CDMOs: Which Choice Will Your Biopharma Make?

Today’s growing biologics challenges make the choice of a CDMO critical. You need a trusted and experienced partner from DNA sequence to commercial launch and at each checkpoint along the way.

How Buffer pH And NaCl Affect Size Exclusion Chromatography

Using a design of experiments (DoE) approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

Have Confidence In Your Biopharma Data

Learn what features to look for when choosing a data management system to establish compliant data visibility across teams, sites, and partners, and establish data integrity throughout the product life cycle.

Six Strategies To Improve Your Approach To Fill/Finish Manufacturing

Demand to increase speed and flexibility while maintaining sterility spurs the adoption of novel technologies and materials, all of which introduce new challenges.

Scalable Purification Strategies For Viral Vectors And Vaccines

Large-scale downstream processing of viruses creates obstacles different from many biotherapeutics. This 15-minute webcast discusses purification strategies for vaccine production and gene therapy.  

Optimizing Cell Culture Media Design: A Diverse Panel Reduces Uncertainty

This on-demand webinar reviews best practices for selecting the optimal media for a specific cell line’s growth using a media panel approach to reduce timelines and increase productivity.  

Achieving BLA Success Using A Structured Approach

This webinar focuses on the critical CMC elements of a product’s life cycle and the regulatory submissions support and strategy necessary for a successful biologics license application (BLA).

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