Biopharmaceutical Analysis

Increase Data Flow Demands Strategic Management; image: Sergey Nivens/Stock.Adobe.com

Increased Data Flow Demands Strategic Management

Data management strategy is important for generating successful analytical studies.

Statistical Approaches to Biosimilar Comparability

Appropriate methods for demonstrating biosimilar comparability support regulatory filing.

&L Studies for Cell and Gene Therapies; image: Anchalee/Stock.Adobe.com

E&L Studies for Cell and Gene Therapies

Cell and gene therapy products pose challenges for extractable and leachable studies.

Developing Cell and Gene Therapy Methods

Bioassay methods for cell and gene therapies require reevaluation.

Advancing Enzyme Analysis

December 06, 2021

Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.

Roche Expands PCR-Test Portfolio with Completion of Purchase Agreement of TIB Molbiol

December 03, 2021

The companies will focus on the rapid development of polymerase chain reaction assays for emerging pathogens and potential health threats, including biological threats.

Sartorius to Invest in Growing Operations in France

December 02, 2021

Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.

Ensuring Quality When Sourcing Biopharmaceutical Raw Materials

December 02, 2021

Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.

Managing Residual Impurities in Complex Biotherapeutics

December 02, 2021

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Streamlining Glycosylation Monitoring through Automation

December 01, 2021

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio

November 24, 2021

MilliporeSigma’s new ColorWheel flow cytometry portfolio is designed to create antibodies and dyes analogous to a primary conjugated antibody.

Sartorius Offers Redesigned Vacuum Filtration Units with Higher Capacity and Faster Speed

November 19, 2021

Sartorius’ newly redesigned vacuum filtration units are designed to allow for faster and higher-capacity filtration while offering enhanced stability for sample processing.

Lonza Invests in Microbial Development Lab Expansion

November 18, 2021

Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.

Synthace Raises $35 Million to Expand Access to R&D Technology

November 16, 2021

Synthace has raised $35 million in funding to fuel growth of its life sciences R&D technology.