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Out of the Shadows: The Boom on Biopharmaceuticals
The production of biopharmaceuticals is entering a new decade: Increasingly complex technologies and processes are establishing themselves to meet the rising demand. In focus are patient safety, quality, and efficacy of the biopharmaceuticals. The boom in biotherapies and the increasing expectations for personalized medicine require bioproduction that is scalable, flexible, safe and reliable. Robots, as a part of automation, are a key to making production future-proof. Robotic arms capable of working flexibility within an isolator are just one example of technology concepts that machinery manufacturers are developing for pharmaceutical companies to enable efficient and economically viable production of small batches.
Cellular Origins enables therapeutic developers to use the tools they want at the scales they need.
The effort to scale biotherapy production and meet the demand for personalized medicine is well underway, and robotic automation is taking on an expanded role. There are numerous possibilities for robotic automation in biotherapeutics, and by extension many other pharmaceuticals. Suppliers and system integrators are finding new ways to transform production, from Grade A/B environments to inspection, final packaging and palletizing.
The term “biotherapies” generally refers to medicinal products, including biopharmaceuticals, that are derived or produced from biological sources such as bacteria or animal cells. Biotherapies can also be the product of gene therapy, involving the insertion of genetic material into cells; cell therapy, in which healthy cells are transplanted; or tissue therapy. Recombinant proteins, vaccines, and monoclonal antibodies are among the most significant products.
Biotherapies are particularly useful for treating chronic diseases such as cancer, diabetes, and rheumatoid arthritis. The techniques and technologies of biotherapy also play a central role in personalized medicine, where demand continues to surge. These and other drivers make biotherapeutics one of the pharmaceutical sector’s fastest-growing segments. Producing biotherapeutics at scale, however, poses significant challenges. Minimizing risk, maintaining consistent product quality, and optimizing process control are all important factors.
Cell and gene therapy (CGT) manufacturing is a complex process, often involving hundreds of steps. Numerous variables can affect the quality, safety, therapeutic efficacy and commercial viability of these sophisticated biologics. With the market growing rapidly, the race is on to scale manufacturing and meet rigorous GMP and cleanroom requirements. Technology offers ways to increase production and ensure quality while decreasing risks and costs as volumes increase.
BAUSCH Advanced Technology Group (BATG) engineers and manufactures controlled and aseptic fill-finish machines for the life sciences sector, with a specialty in processing solutions for parenteral medications. The company developed its Vers-A-Tech™ (Versatile Aseptic Technology) platform specifically for CGTs, enabling the aseptic filling and closing of multiple dosing formats including nested vials and syringes as well as IV bags on a single machine.
The impact of the revised GMP Annex 1 currently seen in generic drug manufacturing will push the industry overall to adopt more stringent contamination control strategies in terms of hygienic design and equipment cleanability. Manufacturers of personalized medicine will invariably follow the same rules. But thus far, the need for Grade A compatibility, and more recently GMP Annex 1 compliance, have posed a barrier to the use of mobile robotics in biotherapeutics.
The most promising solution lies in using robots that align with GMP standards and use FDA-compliant materials in the production of biotherapies and biopharmaceuticals. While the use of robotics in bioproduction is relatively still in its infancy, it is apparent that the parallel production method will bring even more robots into the bioproduction space. As this new bioproduction paradigm takes form, the future looks increasingly mobile.
