11.24.25 -- BioPharma Industry Loves New FDA PreCheck Program

Discover how KBI Biopharma scientists used advanced mass spectrometry and cutting-edge analytics to solve real-world manufacturing challenges and prevent costly setbacks. Through two powerful case studies, you’ll see how peptide mapping and LC-MS analytics uncovered hidden impurities and degradation issues before they derailed development—proving that early analytical investment can safeguard your product quality, timeline, and bottom line. Click here to learn more.

Achieving reliability requires deep process understanding and rigorous control strategies that span the entire product lifecycle, from early development through commercial manufacturing.

The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside.

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

The BD Vystra™ Disposable Pen for Semaglutide is a generic drug-device combination, designed for usability and regulatory compliance, showing comparable performance to the reference device.

The results of our DOE study identified TB media, supplemented with feed, and glycerol as a carbon source, as the optimal medium for the production of this pDNA construct in One Shot Top10 E. coli.

Delve into the specific advantages of dual-sourcing in pharmaceutical fill/finish, exploring how this approach can bolster supply chain resilience, increase capacity, and accelerate commercialization.

Early-stage biopharma teams face tough choices in injectable development. A strategic middle ground may be the smartest path to avoid the risk of under- and overspending.

In cell line development, application of targeted integration cell line technology boosts development speed. Then, a proven production platform facilitates seamless scaleup to GMP manufacturing.

The monoclonal antibody intermediate is engineered for precise delivery of the linker-payload complex. See how rigorous storage measures ensure its quality—crucial for conjugation and functionality.

Size homogeneity of a mAb in solution is crucial for comparability and characterization. Here, an IgG1 antibody was cleaved into antigen-binding fragments via pepsin and papain digestion, then purified.

Learn how to accelerate the journey of ADC candidates from early discovery to clinical development, enhancing the success rate of translating preclinical discoveries into effective cancer treatments.

By using our proprietary non-viral gene insertion technology, GPEx® Lightning ensures rapid development timelines and high-yield production, making it an ideal solution for complex biologics.

Here, we discuss how our scientists worked seamlessly with a California-based biotech to advance its challenging molecules to the point of being in the clinic.

Our dedicated team of in-house design specialists deliver insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions.

Move drug development into the modern era with a CRO that offers assay development and validation, bioanalytical testing, sample prep, and more.

ArQ is built around our primary cyclic olefin copolymer (COC) drug container. It offers an autoinjector that is simple to use, with the flexibility and ability to deliver a wide range of viscosities and volumes.

By streamlining timelines and reducing risks in downstream processes, AbZelect™ enhances efficiency, helping developers navigate the IND pathway more effectively and overcome critical milestones.