By allowing developers to bypass comparative efficacy studies when advanced analytics are successful substitutes, the FDA draft guidance avoids one of the most expensive steps, potentially cutting years from timelines and expanding patient access. For developers though, the burden doesn’t disappear; it shifts directly from clinical trials to analytical testing.
The development of biologics, from initial molecule selection to commercial product, presents complex challenges related to stability, manufacturability, and immunogenicity. Skipping essential risk assessments can lead to costly consequences, including reformulation, reduced shelf life, additional testing, regulatory delays, or even project termination. Download this article to learn more about how a structured, data-driven developability workflow can de-risk biologics during early stages of development.
Catalent’s GPEx® Lightning platform now integrates HEK cell line development, delivering faster timelines, higher titers, and consistent product quality for complex biologics. By combining precise genome engineering with high-throughput screening, the system accelerates cell line creation from months to just four, even for difficult-to-express proteins. This paper expands on the platform’s proven CHO capabilities, offering developers a robust, scalable solution for next-generation therapeutics from discovery to GMP manufacturing.
Protein A resin is an essential tool used to purify monoclonal antibodies (mAb); however, it can also be the costliest step in downstream bioprocessing. To prolong the lifetime of your protein A resin and therefore reduce operating costs, this performance study showcases a novel protein A resin’s ability to withstand extensive cleaning before experiencing a loss of binding capacity.
Each additional step in monoclonal antibody (mAb) downstream bioprocessing increases operating expenses and reduces the recovery of precious product. This Application Note, demonstrates how Multi-Column Chromatography (MCC), an integral part of continuous biomanufacturing, reduces operating time, buffer consumption, and resin usage, thereby decreasing operating expenses.
Now more than ever, researchers are leveraging the power of monoclonal antibodies (mAbs) to fight life-threatening diseases. To support scientists worldwide in their purification efforts, this Application Note details an example workflow to optimizing purification steps for mAb capture, the most critical step in downstream bioprocessing, using a novel protein A resin.
This eBook presents compelling examples of how the powerful Pro iQ Plus mass detector can significantly elevate analysis and QC in biopharma.
This webinar covers quantitative bioanalysis strategies to support mRNA drug development using LC-MS, including sample preparation, surrogate peptide selection, LC-MS method development, and verification/validation.
This technical note demonstrates a sensitive method to quantify a glucagon-like peptide-1 (GLP-1) analog, semaglutide, in rat plasma on a high-end triple quadrupole mass spectrometer.
This technical note demonstrates a sensitive method for the quantitation of pasireotide in human plasma using high-resolution accurate mass spectrometry. A lower limit of quantitation (LLOQ) of 0.05 ng/mL was achieved in extracted plasma samples.
Explore best practices for LC-MS analysis of oligonucleotides to get the best results possible, quickly and easily.
This technical note demonstrates a highly sensitive, robust and rapid workflow to quantify TL 13-112, a selective ALK degrader, and its inactive control, TL 13-110, in rat plasma using a high-end triple quadrupole mass spectrometer.
The path to ADC success demands precision – from DAR optimization and linker stability to rigorous safety profiling! Discover how novel conjugation and payload-linker platform empowers the rational design of next-generation ADCs with enhanced therapeutic potential —improving efficacy, stability and safety.
Host cell protein (HCP) analytics have evolved dramatically over the past 25 years from early “black box” approaches with only semiquantitative outputs to advanced mass spectrometry (MS) methods capable of identifying every HCP in a drug substance. Although HCP ELISAs remain semiquantitative, they are no longer opaque. This paper demonstrates how leveraging advanced technologies ensures that both generic and process-specific ELISAs are fit for purpose and support data-driven risk assessments for product safety. It also highlights case studies on HCP antibody coverage analysis using 2D-PAGE and MS-based approaches, along with new data from the Cygnus CHO Lipase Assay using stable isotope–labeled peptides and PRM-MS absolute quantification.
This scientific poster showcases how GPEx® Lightning enables precise, digital control of gene expression for complex biologics. By leveraging targeted integration into ~200 Dock sites and a single optimized construct, developers can fine-tune gene ratios for co-expression of enzymes, cofactors, and multi-chain proteins. Learn how this approach streamlines screening, boosts titers, and shortens timelines—even for products with unknown stoichiometry.
Discover how Catalent’s GPEx® Lightning platform revolutionizes cell line development for complex biologics. This executive summary highlights how the platform enables rapid, high-titer expression of multispecific antibodies and other challenging proteins—accelerating timelines, improving production efficiency, and supporting commercial-scale manufacturing. Learn how tunable expression and digital control empower your team to overcome development bottlenecks and drive innovation in next-generation biologics.
This whitepaper explores biocapacitance measurement as a process analytical technology (PAT) for real-time biomass monitoring in mammalian and microbial systems. Learn how this QbD-aligned approach enhances upstream process control, reduces reliance on post-batch testing, and supports continuous manufacturing. Three real-world applications illustrate its impact on process visibility and efficiency.
Catalent’s GPEx® Lightning platform delivers stable, high-yield cell lines with unmatched speed—achieving titers up to 15g/L for mAbs and 11g/L for bispecifics. With 25-day pool generation and up to 12 weeks saved on development timelines, this offering sheet outlines key performance metrics and benefits that make GPEx® Lightning a game-changer for biologics developers.
In this video, discover how G-CON partnered with NIIMBL on Project Blackhawk, transforming a 50-year-old warehouse into a GMP-like plasmid production facility using prefabricated POD® Cleanrooms. This innovative POD®-based approach integrated all utility systems, allowed renovation and construction to happen in parallel, and drastically accelerated the project timeline. The result: a demonstration of how GMP-capable facilities can be mobile, rapidly deployable, and adaptable even in minimal infrastructure environments. The project was supported with funding from the National Institute of Standards and Technology in the Department of Commerce under 70NANB21H085.
In this technical paper, Pete Makowenskyj, Sr. Director of Design Consulting at G-CON, explains how cleanroom facilities handling hazardous materials must balance patient safety, product sterility, and operator protection. The paper outlines the regulatory landscape, highlighting gaps between contamination-control guidance and containment requirements for high-risk agents such as ADCs, radiopharmaceuticals, and spore-forming organisms. It details key design considerations—including pressure schemes, HVAC zoning, filtration, and decontamination strategies—that ensure safe, compliant operations. The paper also emphasizes the value of prefabricated cleanroom solutions for achieving tighter environments, flexibility, and future-proofing.
The 503B outsourcing facility market operates under unique pressure: meeting FDA cGMP standards while maintaining agility, sterility assurance, and scalability to serve an ever-expanding network of hospitals, clinics, and health systems. As patient demand and regulatory oversight increase, traditional construction approaches struggle to keep pace. Prefabricated G-CON POD® Cleanrooms offer a transformative alternative—delivering speed, compliance, and future flexibility in a single integrated solution while also dramatically driving risk out of the project.
G-CON provided The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) with prefabricated POD® Cleanrooms to rapidly establish a GMP-like plasmid production facility within a renovated 50-year-old warehouse. The solution included prefabricated POD® Cleanrooms and all necessary utility systems, enabling parallel renovation and significantly accelerating the project timeline. The project was supported with funding from the National Institute of Standards and Technology in the Department of Commerce under 70NANB21H085.
Though we didn’t know it in the 17th century when a dog was injected using goose quills, we know it now: Bacteria and other contaminants can make patients very ill. That’s why the final aseptic filling step is so critical for making injectable drugs. How can we get better at protecting drug quality and patient safety? This e-book takes you on a journey to answer that question and others. Each chapter gives you practical insights: Dive into the “human factor” and why it continues to confound us. Discover why we need to go far beyond monitoring to keep contaminants at bay. Learn why regulators encourage the use of modern barrier technologies, such as gloveless isolators. Explore why airflow studies and computational fluid dynamics are key tools for qualifying aseptic filling processes. Learn how real-time tools for environmental monitoring can save batches and protect patients. Finally, get strategies for navigating complex regulations and see how innovation is helping companies deliver new therapies quickly and safely.
Perfusion-based upstream processing is redefining the production of biopharmaceuticals. By enabling continuous media exchange, perfusion systems maintain high cell density and cell health over longer periods, delivering higher productivity than traditional fed-batch approaches. The result is greater process efficiency, improved scalability, and broader access to affordable therapies. As Biopharma manufacturers face increasing pressure to accelerate timelines and reduce costs, perfusion technology offers a powerful path forward. This executive summary explores practical strategies for implementation, key process control insights, and real-world case studies demonstrating the advantages of perfusion-based production.
De novo assay development holds great promise for future drug discovery projects, potentially reducing costs, improving success rates, and ultimately benefiting patients by accelerating the development of safe and effective therapeutics. Learn what you need to know with regard to new biomarker assay development.
As the biopharmaceutical industry continues to prioritize precision and purity, material suppliers are adopting increasingly rigorous standards to combat particle contamination. Unwanted particulates in drug products, especially injectables, can lead to significant economic losses and, more importantly, pose serious risks to patient safety. Effective mitigation requires collaboration with partners who possess deep expertise in contamination control. Drawing on its heritage in the semiconductor industry, Entegris applies an exceptional level of sensitivity to purity and particle management, supported by robust quality systems, advanced contamination control technologies, and proprietary detection and sizing platforms. This paper examines the lifecycle of particle contamination in biomanufacturing and highlights practical strategies to mitigate its effects.
CDMS is reshaping the characterization of complex biotherapeutics by enabling precise analysis of large, heterogeneous biomolecular complexes and gene therapy vectors. This article explores how CDMS enhances resolution in quality assessments across biotherapeutic development and structural biology research—surpassing the capabilities of conventional analytical techniques.