Abzena

Potency assays play a critical role in developing Antibody-drug conjugates (#ADCs), ensuring their functional integrity and consistency from early research through to lot release. However, biological variability and evolving regulatory requirements demand a strategic and progressive approach.   In our latest blog, Abzena's experts Dr. Erika Kovacs, Dr. Alena Nikolskaya, and Dr. Jeffrey C. Mocny, Ph.D., share their insights into the key considerations from both a development and regulatory standpoint that need to be taken into account when developing a successful potency assay.   From addressing the various challenges like complex mechanisms of action (MoA) and validation to using appropriate reference standards and controls, they share their expertise on how to develop reliable and accurate assays that drive your program forward.   Access the full blog here: https://lnkd.in/ev5x7KCc   #PotencyAssays #AnalyticalDevelopment #CDMO #DrugDevelopment #CRO

The success of developing biological drugs hinges not just on the initial breakthrough, but also on consistent production at a scale that meets the quality standards required for clinical trials and commercialization. That's why optimized process development strategies are essential to delivering consistent product quality while reducing risks.   At Abzena, both upstream and downstream process development are crucial parts of our service offering. Our latest info sheet explores our comprehensive and integrated approach which combines cutting-edge technologies, deep expertise, and collaborative partnerships to ensure that each product is developed with precision and efficiency.   From upstream processes to enhance cell growth and product quality to downstream processing expertise to ensure high purity and yield, our robust capabilities de-risk and streamline scale-up to ensure successful clinical and commercial outcomes.   🔗 Access the full info sheet here: https://lnkd.in/gPjNvpmB  #Biologics #ProcessDevelopment #CRO #CDMO #TherapeuticInnovation

Join us next Tuesday, December 17th, for a live panel webinar exploring strategies to optimize Cell Line Development (CLD), reduce timelines, and lower costs.   Dr. Campbell Bunce PhD MBA, Chief Scientific Officer, and Dr Brett Verstak, Director of Cell Line Development, will be joined by ProteoNic’s Jonathan Frampton, VP of Business Development, to share their expertise on overcoming CLD challenges.   Learn how innovations like AbZelectPRO™, powered by Abzena’s CHO-K1 cell line and ProteoNic’s 2G UNic® vector technology, can accelerate IND-enabling data generation while enhancing productivity and minimizing risks.   Register for the webinar here: https://lnkd.in/ecWYemrk #Webinar #CellLineDevelopment #Biologics #CDMO #Innovation

Bioconjugation is transforming targeted therapies by linking powerful agents to biological targets, enhancing efficacy, and reducing adverse effects. In our latest whitepaper, we explore the variety of conjugate types that are now accessible, each designed to enhance medical outcomes in various therapeutic areas. In oncology, Antibody-drug conjugates (#ADCs) deliver precise, life-saving treatments, while immune-stimulating conjugates (ISACs) activate the immune system to fight cancer. Antibody-oligonucleotide conjugates (#AOCs) are advancing treatments for genetic disorders like FSHD and how radioimmunoconjugates (RICs) are providing targeted radiation for diagnosis and therapy. We also highlight how conjugate vaccines continue to improve public health by preventing diseases like bacterial meningitis.   Discover how these innovative therapeutics are addressing unmet medical needs & improving patient outcomes: https://lnkd.in/gRB27wnn #Bioconjugates #Biopharmaceuticals #CRO #CDMO #Innovation

Unintended immune responses can severely impact the safety and efficacy of biotherapeutics, resulting in delayed timelines, increased costs, and suboptimal outcomes for patients. Understanding and mitigating immunogenicity risks early ensures a successful & streamlined development pathway.   Our latest info sheet, "Advanced Immunogenicity Assessments," details how Abzena’s comprehensive immunogenicity testing solutions provide the robust data needed to guide informed decision making. From whole molecule risk assessments using our EpiScreen® 2.0 platform to 'hot spot' identification with MAPPs, Epitope Mapping and iTope AI, our fully integrated and custom approach provides your with the data you need to navigate regulatory requirements and progress confidently toward the clinic.   Access the info sheet to learn how our extensive immunogenicity expertise can help support the development of your biotherapeutic: https://lnkd.in/ecEPwtXu   #Immunogenicity #DrugDevelopment #Biologics #CDMO #CRO

Developing biologic therapeutics, like antibodies, require a robust analytical strategy that can provide you with rapid and accurate data to drive informed decision making at each stage of development. Without reliable data, critical milestones can get delayed and overall program risk increases.   Abzena’s LabZient™ analytical platform helps overcome these challenges by efficiently generating the high-quality data needed to better understand a molecule’s characteristics and behavior. By employing advanced predictive in-silico evaluations and standardized methods, LabZient™ greatly reduces the uncertainty associated with analytical methods and streamlines the process from molecule assessment to validation at an accelerated pace.    This innovative approach not only expedites the path to IND but also enhances the overall efficiency and accuracy of the analytical process. Discover how LabZient™ can advance your biologic towards clinical success faster: https://lnkd.in/ebVjPU6u   #DrugDevelopment #Biologics #Analytics #CDMO #LabZient™ #CRO

Heading to the Antibody Engineering & Therapeutics Conference in San Diego on December 15-18? If so, schedule some time to connect with our Sr. Director of Business Development, Kevin Ranke while you're there. Kevin would welcome the opportunity to learn about your antibody program's needs and discuss how we can support them with our comprehensive antibody engineering, development and cGMP manufacturing capabilities. Discover how our protein engineering team leverages over 20 years of experience alongside state-of-the-art analytics and bioassay services to de-risk and streamline your biologic development program.   Schedule a meeting to see how our fully integrated capabilities can accelerate your development process and support your goals for successful commercialization: https://lnkd.in/ecRB37B4 #CRO #CDMO #AntibodyEngineering #DrugDevelopment

At Abzena, advancing drug safety through immunogenicity assessment is a key focus in our Bioassay department. Our latest blog features a colleague spotlight on Emily Mallett, a Senior Scientist at our Cambridge site, who plays a vital role in this area. Learn how Emily brought her expertise in immunogenicity and MHC Class II Associated Peptide Proteomics (MAPPs) to Abzena. She oversees multiple service lines, mentors team members, and contributes to the success of our pre-clinical projects. Read more about Emily's journey and her contributions to our immunogenicity efforts: https://lnkd.in/edW-H4ax #Immunogenicity #DrugSafety #CDMO #AbzenaCareers #ColleagueSpotlight

European Pharmaceutical Review's latest issue features an interview with our Global Head of Quality, Troy Wright, discussing the current trends and challenges in the pharmaceutical microbiology field.   From the increased demand for rapid microbiological methods (RMMs) to the most promising technologies in the space, he highlights how the sector’s importance can often be overlooked, despite its key role in bringing safe, quality biopharmaceutical products to market.   "In most companies, QC microbiology is a small unit that does not get the attention needed to deliver safe and quality products to patients in a timely manner. Looking ahead in pharmaceutical microbiology, it is important to focus on the future of our QC labs and invest in people, surrounding processes, and advanced technologies."   Access the full article here: https://lnkd.in/e9jHRu43   #Microbiology #QualityControl #Biotechnology #CDMO #Biopharmaceuticals

Interested in learning how a robust bioassay strategy can accelerate and de-risk your biologic's development process? Access the on-demand recording of our recent seminar featuring our Sr. Director of of Bioassay, Dr. Erika Kovacs, discussing key bioassay strategies that ensure a comprehensive data package for a successful IND submission.   Listen as she delves into essential considerations for developing stage-appropriate bioassays for complex biologics and bioconjugates. Using real-world case studies, she explains how to choose the most appropriate assays at each development stage according to the product’s mechanism of action.   Access the talk here: https://lnkd.in/e62-vnGN #Bioassay #INDSubmission #Biologics #Bioconjugates #DrugDevelopment #CDMO #CRO