Abzena

For sponsors advancing a bispecific toward the clinic and beyond, few technical decisions carry more weight than knowing where standard analytics hold up, where they fall short, and how to build a release strategy durable enough to carry a molecule from first-in-human through commercial approval. In our latest blog, our analytical experts Erika Kovacs, Fabio Rossi & Camila Ortega Ph.D., offer a practical framework for developers navigating final product analytics for bispecific antibodies, from building the release panel around the Target Product Profile, to designing potency assays that can catch a compromised binding arm, to the limits of conventional CE-SDS and SEC methods when it comes to chain mispairing. Their key point is that there's no universal release-testing template for bispecifics, so the analytical strategy must be built early and justified on a case-by-case basis. That's where an experienced partner with broad in-house capabilities spanning chromatography, mass spectrometry, and bioassay development earns its place, not just running the assays a sponsor specifies, but helping shape which ones belong in the panel and when. Access the blog to learn more from our experts: https://lnkd.in/et2_VgFP #Bispecifics #AnalyticalDevelopment #ReleaseTesting #CDMO #CRO

Discovering a molecule's liabilities during scale-up can cost programs months & millions. Finding them early changes everything. In Part 3 of our developability series, experts Rob Holgate & Gary Watts discuss the later stage assessments, where the goal shifts from rapidly eliminating unsuitable candidates to ensuring that the ones selected truly are fit-for-purpose. As molecules scale toward the clinic, new challenges can surface that only rigorous late-stage assessment can address. Stress-testing manufacturability under real CMC conditions, validating immunogenicity in cell-based assays, tackling viscosity in high-concentration formulations, and navigating the added analytical complexity of ADCs/AOCs, bispecifics, & fusion proteins - are all insights regulators have increasingly come to expect in IND/IMPD submissions. As Rob & Gary state: "Later-stage developability assessments are the linchpin that connect promising laboratory discoveries to successful clinical and commercial products. They transform risk into actionable insight." The key takeaway across all three parts is that developability isn't a "one & done" activity. It's a continuous discipline, applied from discovery through IND and beyond. Sponsors that treat it that way are best positioned to deliver safer, scalable, more effective medicines to patients faster. Read Part 3 to learn how: https://lnkd.in/gGVQUrE2 #Developability #CDMO #CRO #IntegratedDevelopment #Derisking

Late-stage attrition in antibody & bioconjugate development isn't just costly — it's largely preventable. Two challenges that keep driving it: - Standard preclinical models often miss how complex biotherapeutics behave in human immune tissue - Immunogenicity risk is assessed too late to influence candidate selection There's a better way to approach both — and it's more achievable earlier in development than many teams realize. Join our experts Erika Kovacs, Sr. Director of Bioassay at Abzena, and Sanne Laura Holt, PhD, Assoc. Director, Immuno-Oncology, Ncardia, on May 21st, as they walk through a practical, case-based approach that integrates iPSC-derived functional immune models with in vitro immunotoxicity and immunogenicity assessments to catch liabilities before they become clinical problems. If you're working on antibody or bioconjugate programs and want practical strategies to protect your pipeline, register today by visiting: https://lnkd.in/gPGkq6RH #Webinar #Immunogenicity #iPSC #Biotherapeutics #CDMO #CRO

What separates a capable ADC CDMO from one that can take your program the distance? Frost & Sullivan recently tackled that question in their Frost Radar™ Report, benchmarking 16 CDMOs across the ADC landscape on innovation and growth. Unmesh Lal, their VP of Healthcare & Life Sciences, recently shared his perspective on the findings, and where Abzena fits in that landscape. A few things he highlighted: - Integration over fragmentation. Eliminating handoffs from discovery through GMP is where timelines are protected & institutional knowledge is preserved. - Conjugation precision matters. Site-specific technology like ThioBridge® means safer, more effective therapeutics. - Analytical depth is non-negotiable. Bespoke characterization methods are what move complex ADC & AOC programs forward with confidence. - Dual US & UK Footprint. Provides multi-regional flexibility and deep FDA and EMA regulatory expertise. Definitely worth a read for anyone navigating CDMO selection in the bioconjugate space: https://lnkd.in/gxKSGEW9 #ADC #Bioconjugates #CDMO #Biopharma #ThioBridge #Abzena

For teams developing ADCs, AOCs, and other emerging modalities, the path from discovery to GMP is rarely straightforward. Fragmented development models have a way of compounding risk and the cost of late-stage surprises keeps rising. Our CSO, Campbell Bunce PhD MBA sat down with Frost & Sullivan's Unmesh Lal to talk through how a more integrated approach is helping teams move faster with fewer setbacks. In this on-demand fireside chat, we cover: - Early de-risking strategies that catch problems before they become expensive - What end-to-end integration really looks like across bioconjugation, analytics, and GMP manufacturing - How to evaluate CDMO partners at the right stage of your program - Navigating the evolving regulatory landscape for novel modalities A grounded conversation for biotech & pharma teams thinking carefully about how they build and de-risk their pipeline. Watch on demand: https://lnkd.in/gimRHqYr #Webinar #Bioconjugates #IntegratedDevelopment #CDMO #CRO

Cell line development (CLD) is quietly shaping your biologic program's fate, often before you realize it. In a recent GEN article, our CSO Campbell Bunce PhD MBA shares why CLD is one of the most consequential decisions in a biologic's development. CLD sets the boundaries for yield, quality, and scalability long before a molecule is fully understood. And because the consequences are delayed, gaps introduced early tend to surface only after significant investment has been committed. As pipelines grow more complex, Campbell makes a compelling case for moving beyond legacy sequential workflows toward a more integrated, data-driven approach that build confidence in cell line performance earlier in the development process. It's a challenge our integrated AbZelectPRO™ CLD platform is designed to address. To reduce variability and improve predictability from the start — giving programs a stronger biological foundation to build on. Read Campbell's full perspective in GEN: https://lnkd.in/gGapkaiE #CellLineDevelopment #Bioprocessing #CDMO #CRO #DrugDevelopment