Biointron Weekly Reports
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Thank you to all who attended the PEGS Europe 2024 Summit in Barcelona, the 15th World ADC Summit in San Diego, and the Society for Immunotherapy of Cancer 2024 Annual Meeting last week! Feel free to reach out to our expert team at +1 (732) 790-8340 or [email protected].
In our latest episode of the new Antibody ABCs video series, we define antibody drug development. Watch the playlist here.
Biointron’s Q3 2024 Antibody Industry Report is out now! Dive into the latest trends, breakthroughs, and insights shaping the antibody industry. Gain exclusive insights into:?
This Week’s News?
Trends – Reliability: Addressing Aggregation, Impurities, and Stability?
This past week, several news features have highlighted challenges that antibody drug products face in the context of reliability and consistency.?
In biomedical science, unreliable antibodies have long hindered research, creating costly reproducibility issues and undermining experiments. Researchers like Carl Laflamme have discovered that many commercial antibodies fail to recognize specific proteins, leading to confusion and flawed data. In response, new initiatives, such as YCharOS, aim to validate antibodies and enhance their reliability by rigorously testing specificity and selectivity. Collaborative efforts involving suppliers, researchers, and organizations are pushing for standardization, the adoption of recombinant antibodies, and unique identifiers like RRIDs to improve tracking. While cultural shifts in lab practices remain challenging, the scientific community is hopeful that these efforts will lead to lasting improvements.?
In a recent paper, scientists focused on identifying previously undetected microprotein impurities in antibody drugs produced using Chinese hamster ovary (CHO) cells, a common cell line for monoclonal antibody (mAb) and Fc-fusion protein production. By employing ribosome profiling (Ribo-seq), they discovered thousands of novel short open reading frames (sORFs) likely encoding microproteins, which are often overlooked in CHO cell biology and host cell protein (HCP) impurity analysis. Using an extended protein database, they analyzed eight antibody drugs via mass spectrometry (MS), uncovering microprotein impurities that vary with cell growth and culture conditions. Their findings enhance HCP detection accuracy in antibody drugs and expand knowledge of non-canonical translation in CHO cells, providing insights to improve therapeutic protein quality and manufacturing efficiency.?
Stability of therapeutic mAbs is a major issue, as aggregation and fragmentation of mAbs is common during various stages of product life cycle due to stress factors like thermal and air/liquid interfacial agitation. These aggregates may reduce mAb efficacy and trigger adverse immune responses, making stability a critical focus throughout the product lifecycle. A recent review provides a broad overview of mAb aggregation, including types, sizes, causes, analytical techniques, and permissible limits, as well as factors influencing aggregation, methods used to study stress-induced aggregation, and strategies to enhance stability, offering valuable insights for improving mAb formulation from manufacturing through patient administration.
To combat this, one?study evaluates the effectiveness of surfactants in preventing mAb adsorption on medical surfaces using a novel device and protocol to detect and quantify mAb adsorption directly on medical plastic bags, ELIBAG. The research reveals that surfactant effectiveness depends on the specific antibody, surfactant type, concentration, and surface material. Findings highlight differences in adsorption behavior between model and real medical surfaces and underscore the importance of using actual medical surfaces to better understand and optimize mAb stability in formulations. This research offers insights into enhancing drug product development and ensuring material compatibility in clinical applications.?
Upcoming Events
Next month, we will be exhibiting at the 3rd Annual Meeting of the Antibody Society of Japan. The event will be held on December 9-11, 2024, at Sendai International Center in Sendai, Japan. Book a meeting with us!?
On December 15-18, 2024, Biointron will also be at the Antibody Engineering & Therapeutics US. The event will be held at the Marriott Marquis San Diego and will hold discussions on bispecifics, ADCs, antibody-based therapies for cancer and neurodegenerative diseases and more.?
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Learn more about Biointron at www.biointron.com, or contact us at [email protected] and +1 (732) 790-8340