The India-based contract research organisation (CRO) said the expansion comes as more studies are being contracted for molecules with high variability, requiring PK and PD studies with a large number of subjects.
DA Prasanna, founder and chairman of Ecron Acunova, explained to Outsourcing-Pharma that: “healthcare reforms in the west have put an emphasis on lowering the cost of drugs.
“Sponsors are trying to respond to this with variations in their product portfolio which require testing,” he added.
With this in mind, he said the expanded unit will now be able to house studies with a larger number of subjects, studies with stringent inclusion and exclusion criteria, and studies requiring ultra sensitive bio-analysis to serve pharma companies in drug development.
Following FDA guidelines
Ecron said its pharmacology unit is following guidelines set out by the US Food and Drug Administration (FDA) which calls for higher specificity and sensitivity in PK/PK studies.
To comply with the regulations, the CRO has added ultra sensitive liquid chromatography-mass spectrometers (LCMS) to the centre and is improving its antibody serological analysis.
Prasanna said the extended site “enables Ecron Acunova to offer solutions according to our clients needs without compromising quality. The capacity expansion will help us to serve our clients at a faster pace.”
This latest development means that Ecron’s total bed capacity in research centres in Mangalore, Manipal and Bangalore now stands at 176 units.
Speaking about the site, Ramdas Pai, chancellor of Manipal University said: “I commend the safe conduct of studies for Indian and global companies, leveraging the scientific and clinical talent of India. It is heartening to note that studies conducted at the centre got US FDA approval, leading to the launch of drugs for the treatment of HIV to cancer.”
Having conducted over 250 phase I studies and 70 late phase studies over the last five years, Ecron claims it has reached the top 3 position amongst almost 100 Indian CROs and said its long-term aim is to become the most reputed PK/PD centre in the eyes of regulators.