STEERLife to help pharma industry transition from batch to continuous manufacturing process

STEER, creator of materials platform technology has announced the launch of STEERLife, a startup that is set to revolutionise the global pharmaceutical industry by changing the way medicines are made and taken, help companies move manufacturing practices 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 pharmaceutical 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. Evaluate pharma world review states that the global pharmaceutical market is expected to reach USD 1 trillion by 2020 with a CAGR of 4.8%. Even from the Indian context, according to Care Ratings, India’s second largest credit rating agency, India’s drugs and pharmaceuticals 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%, aided by a rapidly growing domestic market and newly emerging export opportunities.Moreover the country is expected to become the third largest pharmaceuticals market by 2020 in terms of incremental growth. The pharmaceutical 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 contaminations, 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 pharmaceutical industry faces a dire need to move from batch to continuous processing. STEERLife is excited to present to the industry advanced technologies utilizing 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 & 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% manufacture ‘formulation’ drugs and about 22% 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. 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 • Hot Melt Extrusion Dr. Himadri Sen, Chairman, STEERLife, said, “With unique and seamless blend of engineering and pharmaceutical 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.