Analytical Method Development

Determining Comparability of Biosimilars Through Statistical Approaches

August 31, 2021

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

Biotium’s New Staining Kit Aims to Optimize Exosome Detection

August 26, 2021

A new membrane staining kit, ExoBrite, launched by Biotium aims to enhance the detection of exosomes through flow cytometry.

BioMed X and Janssen Start Up Research Programs in Autoimmunity and Drug Delivery

August 26, 2021

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

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.

Thermo Fisher Expands Gene Therapy Portfolio to Support AAV Manufacturing

July 08, 2021

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

LGM Pharma Launches Analytical Services for Drug Developers and Manufacturers

July 08, 2021

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

Complex Biomolecules Require Analytical Evolution

July 03, 2021

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

Meeting Future Analytical Requirements for Novel Biotherapeutics

July 03, 2021

The future pipeline of complex novel biotherapeutics will require new approaches to analytical assessment.