Whitepapers

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.

How standardized, high-performance surface consumables solve the challenge of non-specific adsorption for metal-sensitive analytes in bioseparations.

You would like to cultivate your cells in a bioreactor but are unsure how to get started? We guide you through a complete bioprocess from inoculum preparation to sample analysis.

We describe the setup of a small scale perfusion bioprocess using a DASbox® Mini Bioreactor System. The system was suitable for the prolonged cultivation of CHO and HEK293 cells.

We tested the suitability of DASbox® Mini Bioreactor System in the long-term expansion of CD4+ T cells as well as the impact of different oxygen tensions on cell proliferation.

In the biopharmaceutical industry, upstream processing for plasmid DNA production is usually optimized at small scale. We demonstrate the feasibility of using the DASbox® Mini Bioreactor System for process development.

Many CDMOs outsource their nanoparticle supply chain, but in house manufacturing of nanoparticles at CDMOs is anticipated to create new market opportunities.

Protect your data from cyber theft or ransom. Learn how modern laboratory informatics from LabVantage can help you remain alert and safe from ever evolving threats.

Speed-to-market, flexibility and process efficiency are more important than ever in biopharmaceutical production. And so is the importance of single-use systems. Single Use Support enables innovative process solutions around aseptic fluid management and improves aseptic liquid transfer in various manufacturing facilities. And yet there is hesitation.Dr. Lorenzo De Benedictis provides insights and outlook on the future of single-use systems in Biopharma.

As more gene therapy applications make inroads into research and clinical practice, the development and safe manufacturing of the therapeutic products involved have demanded more from associated analytical technologies. One of the most widely used gene-therapy vectors is AAV, and key technologies for the characterization of AAVs include CE and LC-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.