SteerLife, a pharma technology start up of Steer Group, is set to transform the drug manufacturing landscape globally with a range of novel application platforms. It invested Rs. 10 crore to set up a development centre in Peenya, Bengaluru to develop patented processes that help reduce pharma manufacturing overheads and enable energy efficient systems. Besides it has also developed processes to provide effervescent drug compositions that improve palatability of formulations for paediatric, geriatric and general patient groups.
The company entered into non-disclosure agreements (NDAs) with five leading Indian pharma multinationals to experience hi-tech continuous manufacturing processes which could simplify and increase production. It will see these companies move away from conventional batch processes that inefficient, wasteful and polluting.
These novel patent pending technologies include the continuous hot melt fragmentation, activated granulation, fluid activated granulation and temperature activated granulation and hot melts extrusion along with process analytics that allows optimising scale-up and reproducibility right from R&D to commercial plant stages. Other potential applications include taste masking, extended release systems, enhanced solubility/bioavailability, containment and drug abuse deterrence, according to SteerLife.
The global pharma is facing regulatory burden on manufacturing compliance, generic abbreviated new drug applications (ANDAs) pricing pressures and first-to- file opportunity. Moreover, in a phase of patent expiries and not enough blockbuster drugs in the pipeline, Big Pharma is working to extend product’s life cycle, enhance bio-availability or even create innovative process. All this can be achieved with our advanced processes and patented materials platform technologies, said Dr. Himadri Sen, chairman, SteerLife at a press conclave.
“This indigenous technology development is in sync with the Union government’s Make in India initiative,” he added.
Further the pharmaceutical industry is constantly grappling with drug recalls because of contaminations, defects, improper testing or inherent safety problems. It is evident that global pharma is scouting for long-term sustainability and efficiency, said Dr. Babu Padmanabhan, managing director and chief knowledge partner, Steer Group.
“We will present to the industry advanced technologies utilising a self-contained, self-cleaning vessel that can transform the bulk material properties in a single step during a very short time interval. We are addressing the most pressing need of the industry in making optimized, quality granules which can be further processed for preparing the final dosage form, said Dr. Padmanabhan.
Although there are currently no regulatory guidelines to mandate use of this technology, USFDA and enforcement agencies would be keen to assess and approve these advanced processes, said Dr. Sen.
Demonstrating the patent pending effervescence technology (EVT) that improves the bioavailability of various classes of drugs, Indu Bhushan, chief technology officer, SteerLife said that this enabled converting dosage forms into palatable oral solutions to enhance acceptability, improve convenience and compliance.