Newsletter | January 11, 2022

01.11.22 -- Why RNA Is The Spotlight Of Precision Medicine

 
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Identifying The Best People To Run A Clinical Study (And How To Hire Them)

No matter how brilliant a clinical trial process or a technology may be, it is useless without skilled, motivated individuals at the helm.  

Reducing Human Error In GMP Pharma/Biopharma Operations

CAI clients often seek help in closing open investigations, but ignore the source of these investigations, even while product sits quarantined. Where clients really need help is in cutting human error off at the source. This blog explores the factors within an organization’s control that impact ongoing human performance.

How To Minimize Supply Chain Disruptions In Biopharma

Read how medical device, pharmaceutical, or single-use system manufacturers manage short-term interruptions to the supply chain without shutting down production.

Single-Vendor Approach Saves Development Time, Economizes Distribution

By minimizing the overall time, complexity, and effort of clients’ projects and reducing the risks, Thermo Fisher’s most complete integrated offering represents a strong single-vendor solution.

Impact Of Scalable Freeze/Thaw Cycling On Protein Stability And Structure

As the biotherapeutic industry continues to adapt to demand, the need for low-temperature storage capable of surmounting the molecular and logistical challenges associated with these treatments has become core to achieving commercial-scale production.

Boost Performance With A Chromatography Resin Update

Although workhouse resins developed in the 1980s are still used in many processes worldwide, you could be missing out on better productivity and performance. Find an answer to the question, "How do I know which modern resin to use in my new projects?"

Understanding The Role Of The Quality Unit In Good Manufacturing Practices

Review the specifics of quality assurance, sterility assurance, compliance, and quality control and the many functions that the quality unit oversees in a GMP facility.

Diafiltration: Efficient Desalting, Buffer Exchange Of Biologic Samples

This article covers the concepts of protein concentration and diafiltration, comparing different ways of performing diafiltration, and their impact on process time, volume, product stability, and recovery.

From Cells To Organs: The Organoid Stepping-Stone

In recent years, biomedical research has pushed the limits of 2D cell culture to develop more advanced models for studying developmental biology and disease-modeling as well as to identify more efficient tissue replacement therapies. Of particular interest in these areas is tailored 3D cell culture approaches that give rise to organ-like structures known as organoids.

Directly Link Phenotype To Gene Expression To Design Better Therapies

Understanding the genetic mechanisms of T-cell polyfunctionality could be critical for developing effective therapeutics. The Opto™ Cell Therapy Development workflow makes it possible to identify these mechanisms by characterizing function at the single-cell level and linking phenotypic data to individual gene expression profiles.

Are Real-Time Gene Therapy Test Results Possible?

Along with the complexities of vaccine and viral-based gene therapy process development comes the need for analytical techniques that can help assess quality parameters, especially in real time.

Leveraging Lessons From The COVID-19 Pandemic To Accelerate The Development And Production Of Viral-Based Gene Therapies

The pandemic revealed that with the proper framework a drug product can be developed, clinically tested, and produced for hundreds of millions of patients in less than a year. What lessons can we apply from this effort for adeno-associated virus (AAV) development and production? And why does the cell and gene therapy arena so urgently need these learnings?

Planned Deviations vs. Unplanned Emergencies: Real-Time Manufacturing Intelligence Is The Difference

Today’s top life sciences manufacturers are dramatically reducing deviations with real-time intelligence. Going digital gives you the power to track and control deviations. Our webinar will show you how.

Strategies To Accelerate Biologics Development, Commercialization

Practical implementation of a modernized cell line development workflow using high-yield cell lines and automated systems accelerates biologics development and commercialization.

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