Forging industry partnerships to accelerate the uptake of continuous pharmaceutical manufacturing

GEA and its partners are leading the way toward smaller, more flexible continuous processing technologies that are transforming the future of pharmaceutical development and manufacturing.

It’s been many years since the US FDA launched its Pharmaceutical Quality for the 21st Century program in 2002, which represented a major springboard for the pharmaceutical industry to modernize its manufacturing infrastructure. The initiative encouraged the adoption of continuous manufacturing (CM) and inline process analytical technology (PAT) systems that facilitated the implementation — from R&D through to manufacturing — of quality by design (QbD) concepts into the complete product lifecycle.

Even with the backing of a major regulatory agency, however, getting a new manufacturing paradigm accepted by the greater drug production ecosystem is no small undertaking. It can be somewhat overwhelming at first, challenging and is often perceived to involve a huge magnitude of change. Yet, first impressions can be misleading!With a continuous line running at a customer’s site for almost two decades, GEA Pharma & Healthcare has, from the very beginning, led the field with flexible development options that improve commercial-scale production and enable greater process understanding to be achieved with smaller quantities of material. Also, the company’s experience in pharmaceutical oral solid dosage (OSD) production technologies and continuous processing experience in other industries, such as chemicals and food, gives GEA an edge when it comes to supporting the pharmaceutical industry in this game-changing switch from batch to continuous. At the heart of GEA’s fully integrated, powder-to-tablet CM solution is ConsiGma®. This complete portfolio of technologies is designed to transfer powder into finished dosage forms in development, pilot, clinical and production volumes. ConsiGma® includes systems for dosing and mixing raw materials, wet or dry granulation, drying, tableting, coating and quality control, which can be integrated in one compact production line...