Managing global release in a changing regulatory environment

An analytical testing perspective Whether you are using an insourcing or outsourcing strategy and working with a CMO or CRO, biotechs and pharmaceutical companies are all pointing toward the same goal: rapidly achieving commercialization of their therapy. However, there are multiple approaches in early phase development that can greatly affect …

Biomarkers & Diagnostics: Growing Influence on Drug Development for NAFLD/NASH

Biomarkers and diagnostics are playing an ever-increasing role in drug development. Personalized medicines, defined as drug therapies used alongside specific diagnostic tests, topped 40% of all FDA approvals in 2018. Across biopharma, drug developers increased their utilization of selection biomarkers, significantly improving the probability of success for their clinical programs.1, …

Speeding Hand Disinfectant Products into the EU Market in Response to the Demand Driven by Covid-19

An unprecedented challenge The coronavirus (Covid-19) pandemic has increased the demand for hand disinfectants, driven by recommendations from bodies such as the WHO. Hand washing is a vital measure for reducing the risk of contracting the virus. The WHO specifically recommends that all individuals “Regularly and thoroughly clean your hands …

An Introduction to Dendritic Cell Biology and Analysis Using Syngeneic Immuno-Oncology Models

Productive immunotherapy driven anti-tumor responses rely on the activation of T cells that target tumor-associated antigens (TAA). The dendritic cell (DC) plays an essential role in the activation of T cell antigen-specific responses, which occurs naturally in the context of infection. However, this same process supports tumor immune surveillance as …

science students working with chemicals in lab at the university.

Precision Imaging of Antibody Biodistribution in vivo With Zirconium-89 PET

Zirconium-89 (89Zr) has revolutionized discovery and translation of Ab (and Ab fragment) therapeutics via PET biodistribution imaging.  With standard, straightforward labeling chemistry, 89Zr provides unprecedented specificity and sensitivity of PET Ab detection (to pM levels).  At Covance we use 89Zr PET as a platform assay for in vivo quantification of:

How to Renew Plant Protection Products – EU Regulations

The legislation concerning the placing of PPPs on the European single market is enshrined in Regulation (EC) No. 1107/2009, with the specific data requirements for ASs and PPPs contained in Regulations (EU) No. 283/2013 and No. 284/2013. The authorization of ASs generally expires after ten years. To enable continued marketing …

Expediting SEND Datasets for an International Regulatory Submission

A case study with Peg Biomedical Co., Ltd Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.   While business between Peg Bio and Covance first started in 2014, the strength and …