STEERLife’s technology solutions are developed using six sigma framework and process analytics making it easily possible to optimise the scale up and reproducibility with control right from R&D to commercial plant stages
STEER, creator of materials platform technology, announced the launch of STEERLife, a start up that is set to revolutionise the global pharmaceutical industry by changing the way medicines are made and taken, help companies move manufacturing practises from the conventional batch to continuous processing (B2C), bringing in much needed control and reproducibility.
The brainchild of two pioneers — Dr Babu Padmanabhan and Dr Himadri Sen — STEERLife is a synergy between engineering and pharma sciences, to create advanced technology solutions and processes that allow for ‘Quality by Design’ as against the inefficient, wasteful, polluting and costly processes that is currently being followed by the industry. The company is led by award winning scientist and former Chief Research Head at Ranbaxy, Dr Himadri Sen as Chairman, Dr Dipak Chattaraj (Former Chairman, Ranbaxy Pharmaceuticals Inc., US and Former President Corporate Development and Strategy, Ranbaxy) as Advisor, Mr. Indu Bhushan (former head of R&D at Mylan) as Chief Technical Officer and Dr Ashwin Rao as AVP Business Development and Intellectual property. The startup will operate in three verticals of the pharmaceutical ecosystem – Technology Solutions, Consulting, Licensing Applications and Differentiated Products.
Evaluate pharma world review states that the global pharma market is expected to reach $ 1 trillion by 2020 with a CAGR of 4.8 per cent. Even from the Indian context, according to Care Ratings, India’s second largest credit rating agency, India’s drugs and pharma industry is likely to post total sales of Rs 2.91 trillion ($47.88 billion) by 2018, with an average yearly growth of at least 14 per cent, aided by a rapidly growing domestic market and newly emerging export opportunities. Moreover the country is expected to become the third largest pharma market by 2020 in terms of incremental growth.
The pharma industry is inundated with challenges related to compliance in manufacturing, resulting in instability, volatility and uncertainty. The number of drug recalls (as a result of contamination, defects, improper testing or inherent safety problems) surged at FDA in 2014, begging for a solution that safeguards against regulatory stricture while addressing the need for long-term sustainability and efficiency.
“The pharma industry faces a dire need to move from batch to continuous processing. STEERLife is excited to 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 optimised, quality granules which can be further processed for preparing the final dosage form.” Said Dr Babu Padmanabhan, Managing Director and Chief Knowledge Officer, STEER, “Our technologies allows for significant reduction in manufacturing overheads, footprint and number of processing steps (2/3) resulting in greater control over quality and energy efficiency, besides negligible waste management, leading to a greener process”.
According to a report by the National Pharmaceutical Pricing Authority of India (NPPA), there are over 10,500 pharmaceutical manufacturing units in India alone. Over 77 per cent manufacture ‘formulation’ drugs and about 22 per cent are engaged in ‘bulk’ drugs manufacturing. “The market global opportunity for STEERLife is enormous. It is easy for the manufacturers to imagine the benefits in terms of quality, availability and savings in time, energy and real-estate.” said Padmanabhan.
STEERLife’s technology solutions are developed using six sigma framework and process analytics making it easily possible to optimise the scale up and reproducibility with control right from R&D to commercial plant stages. STEERLife’s technologies include the patent pending continuous hot melt fragmentation, activated granulation that includes the patent pending Moisture with Shear Activated Granulation (MSADG), fluid activated granulation and temperature activated granulation and hot melt extrusion.
Sen said, “With unique and seamless blend of engineering and pharma expertise, we have created products and formulations that allow patients to simply ‘sip’ instead of swallowing large pills. Our patent pending Effervescence technology (EVT) can help improve the bioavailability of various classes of drugs. Converting dosage forms into palatable oral solutions will enhance acceptability and improve convenience and compliance”. Other potential applications of STEERLife’s technologies include taste masking, extended release systems, enhanced solubility/bioavailability, containment and drug abuse deterrence.
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