Newsletter | July 21, 2021

07.21.21 -- What's Behind BridgeBio's 30+ Drug Candidates?

 
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A Stepwise Approach To Chemistry, Manufacturing, And Controls (CMC) Planning For A Biologics License Application

Lonza has developed a structured and stepwise approach to designing and planning a CMC strategy that is tailored to our customers’ products, processes, timelines, and risk tolerances.

Setting A Strong Foundation To Support Late-Stage Development

After Phase 1 and into Phase 2 trials, it's time to identify the quickest scale-up path for supplying efficacy trials and commercial demands while keeping the formulation as simple as possible.

Establishing A Remote Audit Process As A CDMO

Compliance audits are not immune to the effects of the pandemic. We have been required to adapt quickly to the changing environment to maintain high service levels while protecting employee and client safety.

Robust Chinese Hamster Ovary (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.

Is Your API Ready For Scale-Up? What To Demand From Your CDMO

A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.

Smart Scale-Up: Expanding Viral-Vectors With Microcarrier Bead Technology

Vaccine manufacturers often encounter significant challenges in scaling up the adherent cell cultures used for viral vector-based treatments, and novel technologies are needed to facilitate safe, rapid production.

Scalable Production Of Adeno-Associated Virus (AAV) Vectors

This article examines some of the currently available schemes used in generating rAAV from suspension cultures and describes what it takes to achieve scalable rAAV production.

Electroporation Made Easy For Hard-To-Transfect Cells

Despite its efficacy, electroporation is mistakenly underutilized because of the perceived initial up-front cost in purchasing an electroporator and its association with high cytotoxicity.

Adeno-Associated Virus (AAV) Production Using Microcarriers

Comparison of adherent, suspension, and microcarrier culture for AAV production determines the latter suitable for large-scale production of viral vectors to support gene therapy manufacturing.

Understanding Perfusion Terminology

To evaluate whether a perfusion application will work in a production process, it is critical to have standardized terminology. This white paper explains key terms essential for understanding the process.

Why Biopharma Lifecycle Management?

The biopharma industry has ambitions to accelerate industry 4.0. This white paper explores the major bottlenecks in the development life cycle and the current barriers to effective digital transformation.

8 Key Factors When Selecting A Powered Air-Purifying Respirator System

This white paper explores eight considerations in detail and could be helpful to environment, health, and safety (EHS) managers and supervisors looking to select a powered air-purifying respirator system for their particular application.

Don't Sacrifice Yield For Purity In Downstream Purifications

Mixed-mode resins are often used when unimodal resins fall short of providing the required process productivity and/or process economics. But not all mixed-mode resins are created equal.

Purification Of mRNA On CIMmultus® Oligo dT Column

The large channels and convective mass transfer within the stationary phase eliminate shear forces and allow high flow rates, which leads to very short purification times and high recoveries.

Implementing Continued Process Verification With Bio4C ProcessPad

This e-book describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.

Guide Clients Through Drug Development With Intelligent Collaboration

This article is from a recent discussion with the general manager of Pfizer CentreOne, regarding what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies.

Opportunities And Challenges In Cell And Gene Therapy Development

Dr. Ger Brophy, EVP, biopharma production at Avantor, gives his perspective on cell and gene therapy, one of the most revolutionary trends driving the biopharma sector. 

Expansion Into New Modalities During The Pandemic And Beyond

In this interview, Federico Pollano, senior vice president, global business development, speaks about the company’s recent expansion into the cell and gene therapy market.

Small Pharma, Big Opportunity: 8 Reasons To Look Beyond Size

Should CDMO partner size influence selection for your large molecule project? To choose the best CDMO for you, here are a few reminders to help you look beyond size.

pDNA Manufacturing: An Optimized Platform Process

Explore a platform purification process that addresses the main challenges in the large-scale manufacturing of plasmid DNA (pDNA), such as scalability, quantity, and quality, as well as pDNA analytics.

Practical Use: Osmolality Measurement In Vaccine Formulation Development

How osmolality measurements aid formulation development strategies to ensure consistent and painless injection whether of rapidly developed vaccines, biologics drugs, or cryopreserved cell therapies.

How Downstream Processes Benefit From Connection Technology

Aseptic connectors are crucial to downstream processes to maintain efficiency and sterility. For this reason, CPC is introducing a connector utilizing chemically stable and robust materials.

Microflow Imaging: Subvisible Particle Solution For Cell Therapy

This webinar showcases microflow imaging as a subvisible particle analysis solution to differentiate natural killer (NK) cells and its expansion components with either irradiated K-562 feeder cells or Cloudz™ microspheres.

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