12.19.25 -- The Promise And Paradox Of QbD

Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

Cold storage units like refrigerators, freezers, and ULT freezers are vital to scientific progress, which preserves sensitive materials and supports breakthroughs in medicine, especially amid the rise of cell and gene therapies.

Learn about new materials being considered for single-use cold chain storage containers to reduce or eliminate issues with durability at cold temperatures.

Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.

Explore how AI, QbD, and digital transformation are reshaping manufacturing to accelerate scale-up, reduce defects, and optimize batch release for faster, more resilient operations.

Uncover how our capabilities in phage and yeast surface display can drive your next protein engineering or therapeutic antibody development project forward.

Discover how a novel titer quantification method stacks up against ELISA and HPLC in this data-rich comparison of precision, accuracy, and cost.

Manual QbD methods slow timelines and increase risk. Learn how intelligent, digital frameworks are helping CMC teams improve quality, accelerate submissions, and meet rising regulatory expectations.

Traditional biomanufacturing relies too heavily on trial and error. By integrating AI and mechanistic models into early design, developers can overcome productivity limits and accelerate timelines for complex therapeutic modalities.

The use of AI and machine learning tools can begin the process of moving from predictive, human-driven inventory management and manufacturing processes to genuine, data-driven decision making

Discover how rapid microbial identification using MALDI-TOF improves contamination response, shortens investigation timelines, and enhances efficiency in biopharmaceutical manufacturing.

Get a clear view of oligonucleotide development from synthesis to purification and filtration with practical insights to help you streamline workflows and stay ahead in the fight against disease.

A team of researchers sought to explore the viral infection process before the virus has bonded to tissue, understanding how viruses navigate the epithelial space, through mucus and the periciliary layer.

Manual bottle filling can introduce significant risks, impacting accuracy, sterility, and compliance. Learn how automation can improve product quality, enhance patient safety, and increase efficiency.

Digitizing your visual inspection processes is key to unlocking efficiency and ensuring compliance with global regulatory standards. Learn how to transition from paper-based systems to a digital database.

GLP-1 receptor agonists are revolutionizing therapeutics beyond diabetes. Explore analytical innovations that ensure safety and efficacy as these peptides expand into multiple treatments.

Discover how one family's collaboration with a specialized CDMO enabled the rapid development of a life-saving gene therapy for their daughter diagnosed with an ultra-rare disease.

Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

Explore a structured approach to optimizing and scaling plasmid DNA production using E. coli, with insights into key growth parameters, benchtop feasibility, and pilot-scale performance.

Gain practical strategies and regulatory insight on viral clearance studies, including virus selection, performance benchmarks, case studies, and submission-ready data for biologic products.