The effort to scale biotherapy production and meet the demand for personalised medicine is well underway, and robotic automation is taking on an ever-expanding 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 palletising.
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 personalised 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. Minimising risk, maintaining consistent product quality, and optimising process control are all important factors.
The Bioproduction Challenge
The field of bioproduction encompasses all the complex manufacturing processes and biotechnologies that go into producing biotherapies and biopharmaceuticals. Often this includes modifying the genetic heritage of cells and cultivating them in large-scale bioreactors during upstream production. Risk management and quality control measures are critical at every stage to maintain optimal sterile conditions. Even though market forces exert pressure on manufacturers to minimise production times and increase yields, safety and efficacy cannot be compromised.
Automation is turning out to be a major ally in the effort to meet such demands. An early forerunner, the PUMA robot was used in the Cellmate cell culturing system for the production of biotech drugs in 1993. Today, innovative robotic devices and systems are poised to shape the future of bioproduction, making it more flexible, reliable, and safer.
Case Study: Scaling CGT Manufacturing
Cell and gene therapy (CGT) manufacturing is a complex process, often involving hundreds of steps. Quite a few 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, specialising 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 process includes loading, de-bagging and de-lidding, surface decontamination, filling and stoppering, lyophilisation (freeze drying), crimping and discharge, all with 100% IPC through integrated weighing cells. The system can be semi-automatic or fully automatic, with all sensitive processes taking place in isolators. Restricted access barrier systems (RABS) with glove ports ensure aseptic conditions during manual tasks.
