Biopharmaceutical Analysis

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.

SGS Invests in New E&L Laboratory in India

October 14, 2021

SGS is investing in a new E&L lab in Navi Mumbai, India, that will provide testing services.

AstraZeneca, Merck KGaA, Pfizer, and Teva Team up with Tech and Investment Leaders to Launch New Biotech Innovation Lab

October 14, 2021

AION Labs will be a first-of-its-kind AI/pharma and computational biology innovation lab aimed at spearheading the adoption of AI technologies and computational science.

SGS Completes Expansion of Bioanalytical Testing Laboratory in France

October 04, 2021

The expansion to SGS’s Poitiers facility in France is expected to improve the company’s drug development capabilities.

Increased Data Flow Demands Strategic Management

October 01, 2021

Establishing a data management strategy in-lab is a first step in generating successful analytical studies.

Bioanalytical Studies Support Biosimilars Approval Pathway

October 01, 2021

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

Codex DNA Aims to Accelerate Virus Research with Full-Length Synthetic Genome for SARS-CoV-2 Delta Variant

September 30, 2021

In September, Codex DNA released a full-length synthetic genome for the SARS-CoV-2 delta variant, which may accelerate discovery and development of diagnostics and treatments for COVID-19.

LabVantage Solutions Now Offers LabVantage Enterprise SaaS

September 30, 2021

The new LabVantage Enterprise SaaS adds full configurability and custom interfacing capabilities.

Gyros Protein Technologies Announces New Titer Kit

September 30, 2021

Gyros’ new titer kit identifies adeno-associated virus serotype 9 in vector-based cell and gene therapy manufacturing.

USP Publishes General Chapter 1220 of Analytical Procedure Life Cycle

September 29, 2021

USP is publishing the analytics-focused chapter, which considers validation activities, in advance of the official publication.

CuriRx Launches CuriLytics Platform

September 29, 2021

CuriRx’s CuriLytics platform is a mass spectrometry instrument that will support complex biotherapeutics development.