Abzena

Bioconjugates are complex molecules that can be challenging to analyze and characterize. Robust bioassays and phase-appropriate analytical methods are necessary to produce high-quality, well-characterized material and the data needed to support successful regulatory submissions. ? At Abzena, we address these challenges by leveraging our extensive analytical expertise and state-of-the-art instrumentation to develop and qualify phase-appropriate assays that accurately assess the safety, potency, purity, identity and extended characterization of your biopharmaceutical. Our customized approach delivers rapid, high-quality data to support informed decision-making across the entire drug development lifecycle. ? From compendial assessments on pH and appearance to GMP cell-based potency testing that ensures critical cytotoxicity data for regulatory submissions, our advanced capabilities provide our customers with comprehensive and reliable solutions for their programs. ? Discover how Abzena’s analytical expertise can streamline your bioconjugate program: https://lnkd.in/g7BtucAa ? #ADCCDMO #Bioassays #Analytical #DrugDevelopment #CDMO #CRO

In our continued celebration of World Quality Month, Dr Louise Duffy, our Chief Technical and Quality Officer, shares her thoughts on elevating quality to the next level across everything we do at Abzena. Louise emphasizes to our team that every action we take has a quality impact. Working on highly complex molecules at the cutting-edge of design and development presents unique technical challenges. Hear how Louise reminds us of our critical role in delivering these next-gen therapeutics to improve patient lives. #WorldQualityMonth #QualityExcellence #DrugDevelopment #QualityAndCompliance #CDMO #CRO

At BEBPA, we presented a poster entitled, "Streamlining the Development of Relative Potency Assays for ADCs."?The poster delved into the essential role that relative potency assays play in maintaining the efficacy and potency of biologics throughout their lifecycle. ? This work focused on designing bespoke assays tailored to the complex mechanisms of action (MoAs) of antibody-drug conjugates (ADCs). These assays encompass critical steps in ADC functionality, including target binding, internalization, intracellular payload release, and tumor cell elimination. By comprehensively addressing these processes, we can develop robust, regulatory-compliant assays that support ADC development from early-stage research through clinical trials. ? Access the full poster here: https://lnkd.in/eqbh8WiZ ? #ADCCRO #ADCCDMO #Bioassay #PotencyAssays #DrugDevelopment

Last chance to register! Join our #webinar with Promega UK today at 3pm GMT / 10am EST entitled: "Always Look on the Bright Side of (Cell) Death: Cytotoxicity Assays for Antibody Drug Conjugate Development." Hear from Abzena’s experts, Grant Harradence & Robert J Francis PhD FRMS, as they discuss how advanced bioassays are driving innovation in antibody-drug conjugate (ADC) development. This webinar will explore how Abzena applies developability principles throughout the drug development process. Using two approved ADCs as examples, our speakers will demonstrate the robustness of bioassays in 3D cell culture models and highlight biological methods that support lead candidate selection for further discovery. ? Register now to discover how Abzena & Promega's expertise can help advance your ADC: https://bit.ly/4hRF7mP #ADCCRO #drugdevelopment #bioconjugates #CDMO https://lnkd.in/gGrgftX8??

NEWS: We are thrilled to announce the expansion of our early and late-phase analytical capabilities to now include #GMP cell-based potency assays at our Cambridge, UK and San Diego, CA development and manufacturing facilities. GMP cell-based potency assays play an essential role in quantitatively measuring the biological activity of a biopharmaceutical, and the cytotoxicity of the payload of an Antibody-drug conjugate (ADC), for both GMP product release and stability testing.? Our CSO, Campbell Bunce PhD MBA shares, "Our established expertise and reputation have allowed us to extend our early-phase capabilities to include GMP cell-based potency services at our global sites, addressing a critical need for our customers. This significant milestone further demonstrates our commitment to providing comprehensive, end-to-end support for our customer’s next-generation programs that drive successful outcomes from discovery to the clinic and onwards towards commercial.” Read the full press release here: https://lnkd.in/gM6mEzgd #drugdevelopment #CDMO #CRO #biopharmaceuticals #analytical #bioassays

Philadelphia has a rich history of drug development and manufacturing innovations which support its reputation as a life sciences hub. In a recent BioBuzz feature, Abzena was highlighted as one of the city's prominent CDMOs, for our ongoing contributions to the region, including a $5 million investment in our Bristol, PA facility to enhance bioconjugation and ADC manufacturing capabilities. ? The investment included expanded QC and analytical laboratory space, new chromatography and purification equipment, and facility upgrades. These additions further enhanced the site's existing bioconjugation capabilities and increased its capacity to support the delivery of fully integrated biopharmaceutical drug programs. ? Learn more about how Abzena is driving bioconjugate innovation in the Philadelphia area: https://lnkd.in/eZXADjiF ? #CDMO #ADCCDMO #ADCDevelopment #Bioconjugation #DrugSubstance

Developing a reliable and scalable cGMP manufacturing process for biologics can be complex, often encountering challenges such as process variability, scalability limitations, and stringent regulatory requirements. These obstacles can disrupt clinical and commercial timelines, jeopardizing program success. ? At Abzena, we deliver Clinical to Commercial cGMP biologics manufacturing with a flexible and tailored approach designed to address the unique requirements of your diverse biologic modality. Our comprehensive technology transfer program ensures seamless scale-up by integrating advanced process control and optimization strategies, resulting in robust and consistent manufacturing outcomes. ? With deep expertise in process characterization and validation, lifecycle management, and regulatory compliance, we work as an extension of your team to navigate complex manufacturing challenges, mitigate risks, and accelerate the path through commercialization. ? Discover how Abzena’s expertise can optimize the manufacturing of your biologic today: https://lnkd.in/eHxGADyN #BiologicsManufacturing #cGMP #DrugDevelopment #CDMO #Biotechnology

In celebration of World Quality Month, the Abzena team is spreading the word about our unwavering commitment to Quality and Compliance. As our Head of Global Quality, Troy Wright, shares, "Quality is the heart of everything we do—from developing safe, effective products to building trusted client partnerships worldwide." ? Quality isn’t just a standard; it’s a promise we bring to every drug development project and interaction, continuously raising the bar in the biopharmaceutical CDMO and CRO space. This dedication defines Abzena as a trusted leader, known for reliability, innovation, and excellence in every endeavor. ? Hear what Troy shared with our team to excite and inspire them about such an important core value to our organization. Happy Quality Month! ? #WorldQualityMonth #QualityExcellence #DrugDevelopment #QualityAndCompliance #CDMO #CRO

Avacta Therapeutics recently presented a poster we collaborated on at EORTC-NCI-AACR 2024?entitled, "Affimer? Drug Conjugates Targeting Fibroblast Activation Protein-α." The poster highlights AffDCs as an innovative therapeutic class designed to deliver potent warheads with remarkable precision. ? Using the pre|CISION? release mechanism, these #AffDCs are activated only within the tumor microenvironment through FAP-specific cleavage. This ensures that the toxic payloads are delivered directly to cancer cells, sparing healthy tissues and enhancing tumor penetration. The poster also details how the smaller Affimer? proteins enable effective tumor targeting and robust bystander effects, advancing the promise of targeted biotherapeutics in oncology. ? Access the poster here: https://lnkd.in/gQ25pYUu #CancerResearch #OncologyInnovation #Biotherapeutics #CDMO #CRO #TargetedTherapy

At PEGS Europe last week, our Manager of Protein Engineering, Dr. Christopher Sayer caught up with Life Science Blogger, Rizwan Chaudhrey to share valuable insights into what sets Abzena apart in the field of bispecific therapeutic antibodies. ? Chris also discussed his presentation on "Detection and Correcting of Antibody Imperfections," and poster on bispecific development techniques which highlighted our unique approach for tackling the challenges in developing these complex biologics. ? Tune in to learn more about how Abzena is accelerating #antibody development and partnering with customers to bring innovative therapies from concept to clinic. ? Watch the interview here: https://lnkd.in/e3v_eAt4 ? ?#AntibodyEngineering #DrugDevelopment #Biologics #CDMO #CRO