A serious industry challenge has emerged due to the sheer scale of biotech products that have flooded the market, and the consequent increase in highly varied demand for vial filling. Typically, such products tend to be low volume and high cost, meaning that traditional vial filling solutions built for high volume products are not a suitable option. Flexibility and minimising product losses during filling become of paramount importance. Innovative technologies that meet these requirements reliably, in addition to the pressing quality needs of pharmaceutical and biotechnology companies worldwide, are now critical.
The sector faces a fast changing landscape. Multiple patents for major biopharmaceuticals are expiring. Large numbers of different biotech companies are working to develop the generic versions of biological blockbusters so that they are ready for launch as soon as the patent of the product expires. As biosimilars are hitting the market, forward-looking CMOs, including Recipharm, have taken the initiative to obtain early regulatory authorisation from authorities to fill biotech products to the scale and precise technical needs required. These products need reliable manufacturers that have the capability to master all production challenges. The solutions are now available, with some CMOs able to cater for all format sizes covering a huge spread of precise production needs.