Member login

E-mail address:

Password:
Remember me

Luina Bio Announces New Bio-Manufacturing GMP And Development Facility Expansion

1st September 2020 Highlights • Small scale GMP manufacturing suites open in Q3 2020 • 500L tech transfer and process development site aim for open Q4 2020 • This precedes the next phase with Luina planning to commission a 10,000m2 late phase clinical and commercial production facility targeting late 2021 • New facilities capture more of the global value chain supporting technically advanced microbiome projects • New expanded capacity for bacterial and yeast recombinant projects including vaccine manufacturing including COVID-19 candidates
More info >>

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
More info >>

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>