Whitepapers

The rapid development of gene therapies and high demand for therapeutic proteins pose considerable challenges for biomanufacturing. Complex production processes, product changeover, managing supply chains, and staying ahead of the curve, to name just a few. To accelerate commercialization of biotherapeutics, organizations need to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy. The solution could be a comprehensive approach for screening and characterizing molecular interactions such as protein-protein or protein-drug interactions. It enables a huge variety of applications performed at various stages of biologics development — from early selection to validation to manufacturing. Based on Bio-Layer Interferometry (BLI), it enables real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. Download this eBook to learn how the Octet® BLI platform can streamline workflows, reduce time-to-results, and costs saving on broad range of analytical applications in bioprocessing.

Read a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.

Discover how the Ramina Process Analyzer integrates with the 500L HyPerforma DynaDrive bioreactor to perform accurate in-line measurements and prediction models.

A 2-step platform to purify Pertuzumab is developed, using 1 mL and 5 mL pre-packed columns. Then, scale-up is demonstrated using 50 and 200 mL pre-packed columns.

Octet® BLI systems reduces CQA assay development and run time enabling fast and efficient analysis. Learn how BLI is utilized across a range of CQA applications.

This eBook highlights key considerations for navigating the supply chain as newer biotherapeutic molecules drive growth and support the innovation and manufacture of newer biologics.

Lipid-based nanoparticles (LNPs) are effective non-viral vectors for delivering messenger RNA products (mRNA), most notably used for vaccine production against the recent SARS-CoV-2 pandemic. In this executive summary, you will discover a robust and high-throughput kit-based analysis of nucleic acids extracted from different mRNA-LNP samples.

Partnering with a single CDMO can increase speed to market, ensure production capacity and avoid costly-time consuming tech transfers. Learn more inside this eBook.

Scorpius BioManufacturing discusses the importance of selecting the right CDMO for your next clinical biologic campaign. They cover what attributes are needed through evaluating analytical integration as well as new technologies to look for that will mitigate risk and speed your drug’s manufacturing timelines,

Automated filling of drug substance into single-use bags help optimize fluid management in terms of accuracy, scalability, flexibility, speed and more.

This application note examines the suitability of BioBLU® 0.3c Single-Use Bioreactors and the DASbox Mini Bioreactor System in the long-term expansion of CD4+ T cells.

Given the risks and opportunities inherent in drug development, choosing the right late-phase strategy to optimize timelines and capacity, while remaining flexible enough for changing market conditions, presents a significant challenge to companies developing and commercializing biopharmaceutical products. This piece highlights new technologies and strategies to reduce risk and execute consistently.

This note outlines the benefits of PFS transfer and the key engineering processes required to successfully carry out this process.

Obtain more data without the ambiguity of traditional chromatographic and electrophoretic assays. This notebook compiles app notes generated by the Biopharmaceutical Scientific Operations Team at Waters. They illustrate key attribute monitoring workflows that have been developed to improve and streamline MAM analysis of biotherapeutic proteins.

Liposomal drug delivery systems have become an important part of biologics developers’ armories, with several marketed products now available

Precise temperature control has a significant influence on performance and quality in chemical process engineering. The Unistat range of temperature control systems ensure accurate temperatures and stable process conditions in research laboratories, pilot plants and kilolabs worldwide.

This Application Note presents streamlined workflows for preparation of InstantPC and 2-AB labeled N-glycans coupled with analysis using Agilent LC/FLD/MS.

This application note demonstrates the successful transfer, optimization and scale-up of the Rubella vaccine manufacturing process from static flasks to scale-X™ bioreactors.

This White Paper covers all aspects surrounding AAV vectors including the challenges associated with their manufacturing and explores analytical methods for quality control.