Biopharmaceutical Analysis

Unraveling Protein Characteristics

Mass spectrometry and automation are growing in importance for protein characterization.

Developing Cell and Gene Therapy Methods

Bioassay methods for cell and gene therapies require reevaluation.

&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.

Thermo Fisher Expands Hematology Oncology NGS Portfolio

July 29, 2021

Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.

Byondis and Glycotope Partner on Discovery and Development of Glyco-Epitope-Targeting Antibodies

July 29, 2021

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

908 Devices and Transcenta Partnership Leads to Workflow Innovations

July 28, 2021

Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.

J.T.Baker Robotic Tips from Avantor Offer Precision Workflow

July 28, 2021

Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.

Sciex’s New ZenoToff 7600 Mass Instrument System Offers Increased Analytical Precision

July 27, 2021

Sciex’s recently launched accurate mass instrument, the ZenoToff 7600 system, offers novel ion fragmentation and increased sensitivity for life science research and biotherapeutic development.

Complex Biomolecules Require Analytical Evolution

July 16, 2021

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria

July 16, 2021

Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

July 16, 2021

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

Detecting Residual HCPs Demands a Holistic Approach

July 15, 2021

Gene therapy products present a unique set of challenges for the control of host cell protein impurities.

Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS

July 15, 2021

Sophisticated analytical technologies are complementing traditional approaches in the identification of residual process-related impurities of biotherapeutics.