VALTER PROCESS INNOVATIONS PRIVATE LIMITED

In their own words

Biopharmaceuticals is defined as pharmaceutical manufactured by biotechnological methods with organisms, or their functional components, which are of biological origin. Under this definition, all recombinant proteins, monoclonal antibodies, vaccines, blood/plasma-derived products, nonrecombinant culture-derived proteins, and cultured cells, in addition to tissues from human or animal origin and nucleic acids, are considered as biopharmaceuticals. The most significant protein pharmaceuticals currently available include hormones, enzymes and antibodies. The engine for biological manufacturing comes from ever-improving expression systems. The current technology can be traced back to the dawn of civilization, through cell culture technology. It took two decades of trials and tribulations to bring cell culture from a bench technique at milligram scales to industrial production at kilogram scales. Today, those large-scale stirred-tank bioreactors are key work horse of modern cell culture technology. The current state of manufacturing can be conveniently call the “age of stainless steel.” Large stainless-steel fermenters were a good fit as their science and technology was well developed. However, lurking in the bush was a new enquiry by major regulatory agencies: the quest to control cross-contamination and viral clearance, the two most important causes of the side effects of these drugs. The quality guidelines by the Food and Drug Administration (FDA) and European Medicines Agency (EMEA)began emphasizing the safety issues for cleaning validation and viral clearance, and the industry responded with more robust validation plans to prove compliance. The costs of manufacturing soared, but that did not make any difference because all of these molecules were under patents, and the companies were able to get whatever price they needed to justify these huge investments. However, the biological manufacturing industry began to end with the expiry of patents and the eagerness of the EMEA to start awarding generic approvals of these drugs; suddenly, the cost of production did become a consideration. As the terms ""disposable"" and ""single-use"" imply, such systems are only ever used once. single-use products are typically fabricated from plastics approved by the FDA. These materials are typically supplemented with additives to aid performance and/or prolong usable life thereby ensuring their suitability in biopharmaceutical manufacturing applications. In all cases, the product contact surfaces are free of animal-derived components. Single-uses can be rigid (molded systems) or flexible (bags made from multilayer films) and are often supplied presterilized, having been gamma irradiated at dose levels between 25 and 50kGy although some are autoclaved. This eliminates the need for subsequent sterilization of the equipment, such as the steam sterilization normally required for stainless steel components. Single-uses can therefore be quickly brought into operation. On completion of the process operations, the single-uses used are decontaminated and discarded. Thus, time-consuming and expensive cleaning procedures, which may require the use of corrosive chemicals (which could potentially pose a health hazard to the operator) and water for injection (WFI), often considered as a bottleneck in traditional biopharmaceutical facilities, are no longer required. World’s Leading manufactures and consumers of Biotechnology started to adapt to Single use during the beginning of 2010. But most of the Indian industries are early adaptors / yet to begin the journey of Single use technology. With the advent of COVID-19 pandemic demand for Vaccination has revealed the shortcoming of our traditional manufacturing process and short coming of importing key raw materials required for the Biopharma Industries. This has resulted in delay in production of not only COVID-19 Vaccines but also other essential Vaccines. We are providing indegeinzed Biopharmaceutical solutions to manufacturers of Vaccines, mAb's, CGT, Plasma, API. We are also working on the lines of Aatmanirbhar Bharat.ValTer Process Innovations is dedicated to producing high-quality products that improve the lives of patients worldwide by providing Hardware, consumables, and services which aid in making the Biopharmaceutical manufacturers high-quality effective mAb's, r-DNA Proteins, Vaccines, Cell Therapy products.

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