Analytical Testing

ASSAY VALIDATION – Biomarker Assay Validations – A Time for Change?

John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.

SAMPLE PREPARATION MARKETS – Automation & Application Trends Drive Growth in Sample Preparation Markets

Christi Bird indicates sample preparation remains a critical task in many research and testing workflows across biopharmaceutical, basic research, clinical, and industrial applications. While the market lacks the hype and excitement of NGS, CRISPR/Cas9, or the microRNA and epigenetics boom several years ago, the sample preparation market will always be a slow and steady gainer on an already large market size.

NANOPARTICLE CHARACTERIZATION – One Size Does Not Fit All: Nanoparticle Size Analysis for Nanomedicine Applications

Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.

EXCLUSIVE ONLINE CONTENT

7/10/2018

Endocyte & ITM Announce Long-Term Supply Agreement

Endocyte, Inc. and ITM Isotopen Technologien München AG recently announced that ITM´s subsidiary, Isotope Technologies Garching GmbH (ITG), and Endocyte have signed a long-term global…

7/8/2018

Pfenex Receives Milestone From Merck

Pfenex Inc. recently announced the receipt of a milestone payment from Merck associated with the initiation of the first Phase 3 clinical study of (V114), an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. 

7/8/2018

Immatics Enters Strategic Partnership With Genmab

Immatics Biotechnologies GmbH recently announced it has entered into a research collaboration and license agreement with Genmab A/S to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancer indications.

7/8/2018

Gerresheimer Acquires Sensile Medical

With the acquisition of Sensile Medical AG, Switzerland  under a recent share purchase agreement, Gerresheimer is extending its business model in the direction of an Original Equipment Manufacturer (OEM) for drug delivery platforms with digital and electronic capabilities for pharmaceutical and biopharmaceutical customers.