Medical research has shortchanged women for decades. This is particularly true of older women, leaving physicians without critically important information about how to best manage their health. Late last year, the Biden administration promised to address this problem with a new effort called the White House Initiative on Women’s Health Research. That inspires a compelling question: What priorities should be on the initiative’s list when it comes to older women…
The Dish’s Weekly Biotechnology News – June 21, 2024
This week’s headlines include: Older women are being significantly shortchanged by medical research, Expanded solutions for seamless stem cell research, Hope, despair and CRISPR — the race to save one woman’s life, Sanofi heads out to surf Belharra in $700M biobucks immunology deal, and US FDA approves Merck’s pneumococcal vaccine for adults.
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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Assessing Developability in the Antibody Discovery Stage is A Key to Success
We recently sat down with Dr. George Wang, Vice President of Discovery and Preclinical Services at WuXi Biologics to discuss the 
importance of looking at developability of an antibody early in the drug discovery process. In the podcast, The Importance of Evaluating Developability in the Antibody Discovery Stage, Dr. Wang defines developability and its significance in achieving scalable production during CMC development, which is essential for large-scale manufacturing before clinical trials. He emphasizes the importance of identifying and addressing developability concerns early in the discovery stage to mitigate risks and ensure cost-effective development. Dr. Wang provides examples where developability studies have helped prevent unforeseen costs and timeline disruptions during biologics discovery and preclinical development phases. He underscores that assessing developability can reveal issues with product aggregation, stability, solubility, or manufacturing efficiencies…
How AGC Biologics received approval from both US and European regulators for commercial manufacture of Lenmeldy – A cell-based gene therapy
In this podcast, we spoke with Luca Alberici, Senior Vice President and General Manager, Milan Facility, AGC Biologics about the road to their recent EC and FDA approval to commercially manufacture Lenmeldy™ and their future plans in cell and gene therapy…
Discover Optimal Cell Culture Conditions Efficiently with the New Online Cell Culture Select Tool
The ability to culture cells in vitro has allowed researchers to unravel the complexities of human biology, understand disease mechanisms, and advance drug discovery, which has led to countless breakthroughs in biomedical research. With thousands of
cell lines in use today, each with their own distinct growth requirements, researchers face the challenge of selecting appropriate culture media and reagents. When working with a new cell line, it is common to consult the literature and draw upon the institutional knowledge of other labs to determine the best cultureware, media formulation, and subculturing or cryopreservation techniques. However, the lack of standardization across labs working with the same cell line poses challenges with respect to experimental reproducibility, emphasizing the importance of establishing cell culture best practices to ensure success…
The Ongoing Importance of Cell Line Authentication
Cell lines are indispensable tools in both academic and industrial laboratories worldwide, forming the foundation of many breakthrough discoveries. However, cell line misidentification represents a longstanding and pervasive problem in basic and translational research that poses a significant threat to research reliability, integrity and reproducibility.
Studies estimate between 18-36% of cell lines utilized in biomedical research are contaminated and/or are completely misidentified1. As of January 2023, the ICLAC Register of Misidentified Cell Lines has documented 582 instances of cell line misidentification. Additionally, a study aimed at authenticating 278 human tumor cell lines used in China found that nearly 46% of the samples were either cross contaminated or misidentified2.A cell line becomes misidentified through cross-contamination, mislabeling, or other laboratory errors, meaning that it no longer corresponds to the original donor and may in fact come from an entirely different species, tissue or disease3…
Why Teamwork and Collaboration are Necessary for Successful Viral Vector Characterization
Characterizing viral vectors presents several challenges, primarily due to their larger size compared to other biologics like fusion 
proteins, monoclonal antibodies, and small molecules. Their heterogeneity and complex structure further complicate characterization efforts. To address potential failures in the lab, meticulous planning is essential, including anticipating mistakes, allowing margins of error in assays, and careful experimental design. In a recent “Rewrite the Rules” vodcast, Jill Bradley-Graham from Sanofi, discusses why viral vector characterization is particularly challenging and why teamwork and collaboration are key. In the episode below, Jill shares the challenges that scientists in viral vector characterization face. She also explains why collaboration is key for newly emerging fields and provides insights on how to turn “failures” into opportunities…
Getting the Most From Inline Buffer Formulation: MOTIV® Performance Data Review
In this mini-webinar Nainesh Shah, Sr. Application Engineer with Asahi Kasei discusses the benefits of inline buffer formulation
and presents performance data on the MOTIV® inline buffer formulation system with case studies demonstrating the flexibility of MOTIV to create a wide variety of complex buffers.
The MOTIV system was originally launched in 2007 as IBD (Inline Buffer Dilution) and has since undergone several modifications and enhancements. In 2013, it evolved into a standard 3 pump system, with further improvements in 2015, including the addition of a reagent tracker for better chemical tracking. Subsequent upgrades in 2016 introduced a five pump system, and in 2018, larger custom units with six and seven pumps were developed. In 2020, IBD was officially renamed MOTIV, and in 2023, a single-use version of the system was launched to eliminate the need for SIP/CIP procedures.
Biopharmaceutical Manufacturing: Strategies for Navigating Raw Material and Process Changes
Change in inevitable, especially in biopharmaceutical manufacturing. The biopharmaceutical industry is constantly evolving with advancements in processing technologies and raw materials providing continuous improvement opportunities for manufacturers to increase efficiency, reduce costs, and mitigate risks while maintain product quality and safety across a product’s lifecycle. That said, raw materials like chromatography resins used in downstream biopharmaceutical manufacturing of regulated products are subject to strict oversight. Any changes made to the manufacturing process must be carefully evaluated using both science- and risk-based approaches and reported to regulatory authorities to ensure the safety and quality of the final product is not affected…
Advancements in Buffer Management and Single Use Inline Buffer Formulation
In this podcast, we spoke with Nainesh Shah, Senior Application Engineer at Asahi Kasei Bioprocess about buffer management 
including the benefits of inline buffer formulation, and single use inline buffer formulation systems.
We started the podcast by talking about how critical buffer management is to bioprocessing. Mr. Shah discussed how buffers are required in large quantities during the biomanufacturing process and that traditionally buffers were made in large tanks, stored, and used as needed. However, now real estate in the bioprocessing industry is at a premium and companies are looking to utilize new technologies that can reduce facility footprint. For buffer management, it makes sense to create buffer on demand to reduce the footprint dedicated to buffer production in the past.
Cytiva™ Protein Select™ Resin – A new affinity resin for recombinant proteins
Cytiva™ Protein Select™ resin is an affinity chromatography resin for purifying recombinant proteins using the self-cleaving Cytiva™ Protein Select™ tag. This technology simplifies tagged protein purification when used in research and standardizes purification during process development and later phases of any protein that does not have an affinity binding partner.
Headlines:
“Expanded solutions for seamless stem cell research,” Press Release
AMSBIO, a leading provider of innovative products and services for the life sciences community, announces the launch of its Expanded Stem Cell Synergy Solutions. Over the last two decades AMSBIO has established itself as a leading international supplier of solutions for streamlined and efficient ES/iPS Cell Culture using feeder-free StemFit® media and iMatrix recombinant laminin extracellular matrices. Backed by knowledgeable support teams in the UK, USA, and Germany – AMSBIO has expanded its products and services across the entire stem cell workflow, from sourcing and growing to storing, differentiating, and manufacturing…
“Hope, despair and CRISPR — the race to save one woman’s life,” Nature
When researcher Arkasubhra Ghosh finally met Uditi Saraf, he hoped that there was still a chance to save her. Ghosh and his collaborators were racing to design a one-off treatment that would edit the DNA in the 20-year-old woman’s brain cells and get them to stop producing toxic proteins. It was an approach that had never been tried before, with a long list of reasons for why it might not work…
Sanofi is offering Belharra Therapeutics up to $700 million in biobucks for a tow out to surf the waves of small molecule drug discovery in immunology. The deal includes $40 million upfront and in near-term milestones for Belharra to use its non-covalent chemoproteomics platform to look for new ways to drug targets selected by Sanofi. The remaining cash will be in milestones spread throughout the collaboration, plus royalties…