Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Emerging Therapies Drive Analytical Advancements

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Analyzing Exabytes

Effective analytics will eliminate failures, deviations, and non-conformances.

FDA Issues NIR Guidance

August 09, 2021

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

Preparing for Unexpected Issues in E&L Studies for Biopharma

August 02, 2021

Establishing extractable and leachable studies for complex biotherapeutic molecules poses new challenges for analytical assessment.

Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis

August 02, 2021

A recent innovation in infrared spectroscopy, Microfluidic Modulation Spectroscopy has been shown to improve characterization of secondary protein structure.

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

August 02, 2021

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

Preparing for the Unexpected: E&L Studies in Biopharma

August 02, 2021

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Picking the Perfect Method Development Partner

August 01, 2021

There are some key questions that should be asked by both the sponsor company and the outsourcing partner before undertaking a method development project.

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.

Summa Equity Acquires Majority Stake in Axion BioSystems

July 29, 2021

Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market.

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.