Newsletter | September 9, 2021

09.09.21 -- State-of-the-Art GMP Manufacturing RNA Cell Therapies

Featured Editorial
Industry Insights
How To Build A Robust Packaging Strategy For Rapid Commercialization

Take a look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

Enhancing The Solubility Of L-Tyrosine In Cell Culture Media Applications

Because L-Tyrosine is an important amino acid for protein synthesis and cellular metabolism, finding a solution to its solubility challenge can be critical to maximizing process performance. 

Saving Development Time And Economizing Distribution With A Single-Vendor Approach

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.

Pre-Use Post-Sterilization Integrity Testing: Considerations In Implementation

There has been significant debate over the years between regulatory agencies and the pharmaceutical industry regarding the advantages and disadvantages related to patient sterility risk when performing pre-use post-sterilization integrity testing (PUPSIT) of sterilizing-grade filters. This document will provide items to consider when determining how to implement PUPSIT in a robust manner for a particular application in instances where the decision is to perform PUPSIT.

Manufacturing Strategies To Effectively Industrialize Autologous Cell Therapies

While the first autologous cell therapy commercial products have shown tremendous clinical success, scaling out these therapies while considering individual patient processes is a new challenge.

Expanded T-Cell Harvest With The ekko™ Acoustic Cell Processing System

For CAR-T processes that require a freezing step between apheresis collection and manufacturing, it is critical upon thaw to remove dimethyl sulfoxide (DMSO), a standard component of cryoprotectants, from the product to ensure the utmost cellular health of the apheresis material. We demonstrate how the ekko Acoustic Cell Processing System consistently processes apheresis products.

How To Choose A Sterile Connector

When you’re focused on creating life-altering drugs that are worth millions of dollars, something as simple as a fluid handling connector can seem like a minor concern. But without a reliable and robust connector your batch could quickly be rendered worthless. Learn three considerations to give you confidence when selecting fluid handling connectors for your bio application.

Key Considerations For Laboratory Facility Design Planning And Optimization

Laboratories are an integral part of the pharmaceutical industry. They are used at each stage of the product development. See how this solution allows you to plan projects without having to build new labs and gain the ability to plan better projects, manage inventory, be nimble in responding to demand fluctuations, avoid under and/or over utilization of talent, and implement reliable capital project planning that is based on actual utilization tracking.

Report: Patient Perspectives On Clinical Trial Participation
Informa Pharma Intelligence partnered with Rare Patient Voice to survey trial participants and non-participants to share their insights on clinical research. Ten key takeaways emerged from the survey results, including a few surprises. Read the full report.
Osmolality Measurement Of Lentiviral Vectors For Cell And Gene Therapy
In this webinar Lucia Marani, analytical development scientist from Oxford BioMedica, talks about applications of the OsmoTECH osmometer. Kendal Studd, scientific application specialist for Advanced Instruments, rounds off the session by presenting a summary of published research showing that in vector manufacturing osmolality is a factor in control of stability and aggregation for lentivirus and other viral vector types.
Strategies For Building A Cell Therapy Manufacturing Facility

In this webinar co-sponsored by Precision ADVANCE and Project Farma, a panel of industry experts discuss the challenges faced when building a cutting-edge cell therapy manufacturing facility.

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