Newsletter | December 4, 2024

12.04.24 -- Research Explores Alternative To EU-Banned Triton X-100

SPONSOR

Let Us Handle Your Buffer Preparation

Thermo Fisher Scientific is here to support you with the buffer preparation in your manufacturing workflow. Leaving the non-core activities to us enables you to focus on the patient therapy development. Our capabilities cover off-the-shelf products like WFI, NaOH, NaCl, or EtOH, a library of the most frequently used buffers that are made-to-order, as well as fully customized buffers.

FOCUS ON DOWNSTREAM MANUFACTURING

Research Explores Alternative To EU-Banned Triton X-100

One of the best-known viral inactivation agents is now banned in the EU. A group of scientists explored Virodex TXR-1 as a suitable alternative. Here's what they found.

Achieving Protein A Resin Reduction With Process Transfer

Learn how transferring a batch chromatography process into a multi-column format and scaling that process up to continuous perfusion dramatically reduced protein A resin requirements.

Building A Fully Single-Use Process With Protein A Membrane Devices

Explore results from a study demonstrating the capability of an intensified, single-use downstream process for a fed-batch cell culture harvest producing a representative mAb at an industrial scale.

Turbulent Mixing: Scaling Up Nanoparticle Manufacturing For The Future

Choosing between turbulent and microfluidic mixing methods in your lipid nanoparticle (LNP) production can have a significant impact when scaling up production.

Aseptic Filling Operations: Keep In-House Or Outsource?

Pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and detracts from your strengths in drug development.

Reducing Risk In mRNA Therapeutic Development

Advancements in purification, delivery mechanisms, and stability during storage and transport will enable the future of mRNA-based therapies.

Viral Clearance Under Mild pH Using Protein A Resins

Discover how Praesto Jetted A50 HipH resin offers superior viral clearance at mild pH conditions, minimizing protein aggregation and improving yield during monoclonal antibody purification.

Custom AAV Buffers: Give Your AAV Therapeutic A Boost

Streamline your AAV gene therapy production process with custom buffers. Learn how optimized formulations can enhance purity, scalability, and regulatory compliance.

Simplifying EV/Exosome Research & Development

Modern solutions are continuing to be developed to help those working in biologics overcome historic Exosomes / Extracellular Vesicles challenges.

Support Of Scale-Up, Tech Transfer Through Understanding Equipment

See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

Orphan Drug Aseptic Fill Finish, Clinical Trials, And The Impact Of Advocacy

Orphan drug development is a journey marked by challenges at every step. From patient recruitment to aseptic fill finish, overcoming hurdles is critical for bringing life-saving treatments to market.

Building A Fully Single-Use Process: Protein A Membrane Devices

Uncover how a fully disposable upstream and downstream platform process in antibody production can increase production timelines, enhance scalability, and reduce risk in biologics manufacturing.

How To Plan For Trouble-Free Filter Validation

Here, speakers describe when filter validation should be performed, what is required from an end user and laboratory testing perspective, and how to achieve first-time success for various drug products.

DOWNSTREAM MANUFACTURING SOLUTIONS

Get Your Biologic To Clinic And Market Faster - Catalent

Phenols Chloroform Extraction Protocol - Thermo Fisher Scientific

Caprylate Mixed-Mode Cation Exchange Chromatography Resin - Thermo Fisher Scientific Bioproduction

Selecting An Affinity Chromatography Resin For Your Antibody - Cytiva

FOCUS ON FILL-FINISH

Challenges Associated With In-Use Simulated Administration Of Biologics

Consider some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

New Container Protects Bulk Frozen Biopharmaceuticals

This flexible freeze container maintains package integrity after freezing at -86 °C. (-123 °F) through its durable design, minimizing product loss due to package failure.

FILL-FINISH SOLUTIONS

Automate Your Fill and Finish Process for Precision - Terumo BCT

Sterile Fill/Finish - AbbVie

Connect With Bioprocess Online: