Newsletter | November 2, 2022

11.02.22 -- How To De-Risk Your Biologic's Development And Manufacturing Process

Transition To Closed Processing Systems

In response to the increasing biologics manufacturing industry shift into single-use closed-system processing technologies, as well as increasing regulatory requirements to de-risk processes, one of our facilities is moving routine expansion of suspension cells into a closed process format. Learn about our transition and its comparison to traditional processing.

Higher Order Structure Of Proteins By Circular Dichroism Spectroscopy

The higher order structure (HOS) of a protein comprises its secondary, tertiary, and quaternary structure. An assessment of HOS forms an important part of the physicochemical characterization of recombinant proteins. Learn more about circular dichroism (CD) spectroscopy which is used to study the tertiary and secondary structure of proteins.

Viral Safety Of Biologics: What's Changing With The ICH Q5A Revision?

ICH Q5A is currently being revised to address recent scientific advancements, including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We discuss the expected changes and potential impact on viral safety strategies.

Designing Successful Viral Clearance Studies

Despite careful testing of starting materials and in-process intermediates, there is still a risk that a virus could enter the manufacturing process undetected. From scaling down individual process steps, and, for each step, spiking virus into the specific process intermediate, performing the process step and measuring the virus remaining after the process step, we review how to design successful viral clearance studies.

Taking Charge Of Your Stability Program

With the high costs and long timelines needed to bring a drug to market, improving efficiency and reducing risk, wherever possible, can accelerate your product development and de-risk complex studies such as stability studies. Learn how consolidating stability testing with a single partner offers these benefits and more.

Next-Generation Sequencing For Sequence Identity Confirmation And Variant Detection

The use of next-generation sequencing-based assays in the biosafety testing space has grown dramatically over the past decade with the advent of advanced instrumentation. Once considered to be cutting-edge R&D-only methods, instrumentation and systems have been refined in ways that lend themselves to compliant regulated testing.

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