Newsletter | January 11, 2021

01.11.21 -- The AAV Vector Challenge With Selecta's Dr. Carsten Brunn

 
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Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?

The most common storage is ultra-low temperature storage, but the fastest growing is cryogenic, in vapor-phase liquid nitrogen. This transition is huge. Chain of temperature and custody data is imperative.  

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.

Upstream Bioprocessing In Food And Feed Applications

Bioprocessing has been used for decades for the industrial production of beverages and for the production and preservation of food and feed ingredients. 

A Proven, Cost-Effective, Single-Use Powder Transfer Solution

Powder-handling processes haven’t kept pace with advances in single-use transfer technologies. This application note posits a better way to bring powders to the hydration process for upstream manufacturing.

Next-Gen Bioprocess Monitoring: Smart Data Management And Analysis

A new platform that includes digital technologies and data management, process analytical technologies, and intensified processing will drive next-generation bioprocessing.

Key Factors For Successful Technology Transfer

Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites. 

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.

Using In-Line Sensors For Real-Time Control

There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.

A Model System For Screening Of Optimal Protein Purification Conditions

This study highlights a model system for screening optimal protein purification conditions on a mixed-mode cation exchange resin using a statistical software generated design of experiment model.

Conductivity Testing Of Mixing Systems

This technical bulletin highlights the results of conductivity testing to characterize recirculation mixing performance of single-use systems deployed in QuaDrum rigid outer containers (ROCs).

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. 

Outsourcing A Microbial Fermentation Project To A CMO Partner

This interview with Dr. Lars Geiger, director of global projects at Evonik, reviews key trends and scale-up challenges to manufacture a substance via fermentation.

Thermo Fisher Scientific Pharma Services Global Network

Our objective is to help speed your molecule through early-phase trials to prepare you for commercial success. This e-book explains our comprehensive support to help streamline the end-to-end process.

Insights In Pharmaceutical Manufacturing, Clinical Research, And Technology

ISR conducted approximately two dozen pieces of research for syndication in 2019. This summary highlights learnings from these projects and provides real, usable data for 2020 activities.

Achieving Biologics License Application Success Using A Structured Approach

This webinar focuses on the critical chemistry, manufacturing, and controls (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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