With the approval of now several drugs produced continuously as well as the “ICH Q13”- and “Quality Considerations for Continuous Manufacturing Guidance for Industry” of the FDA being close to release the industry is gaining further confidence in implementing the technology. However, continuous manufacturing has not seen the breakthrough as paradigm shift predicted by many yet. Batch manufacturing is still a default platform for many new drug products, but a change of mindset has started to turn this around!
Quo Vadis Continuous Manufacturing?
Most early equipment (built in the last 15 years) used for continuous manufacturing of oral solid dosage forms was designed for medium product volumes (e.g. matching a tableting capacity of 25-50 kg/h) and low potency drugs. This fact made it difficult for many pharmaceutical companies to justify a business case around switching from batch to continuous. The benefits of going for continuous manufacturing simply didn’t outweigh the higher investment costs in more complex equipment, higher API consumption during early development, and the formation of new production teams familiar with highly complex equipment. And simply the relatively high production volumes did not fit with the pipeline of most new drug products.
Gericke has been one of the leading companies in developing and commercializing continuous feeding and blending equipment to produce oral solid dosage forms. Gericke had presented the first formulation skid on the Achema 2012 and has since successfully supplied continuous manufacturing. Gericke has also additionally realized the demand for equipment specifically for the other ends of the spectra: low-volume high potent and high-volume drug products.
For low volume, high potent drugs, a semi-continuous feeding, and blending unit (the Gericke Formulation Skid Batch GFS-B) was developed. The main benefits are around reduced API consumption during development, no start-up and shut down losses, less complex control strategy as well as suitability for very low dosages (below 1% drug load), and high containment (OEB4/5). This enables the use of continuous manufacturing for batch sizes below 1 kg.
For high-volume products, a new variant of the Gericke Formulation Skid Conti GFS-C can be used. This is a traditional continuous feeding and blending approach suitable for high throughputs up to 500 kg/h and even the supply of multiple tableting or capsule filling lines with a single blending unit. This allows business cases to be built around operational costs as an additional benefit of continuous manufacturing. This solution is very attractive for generics manufacturers or “Over The Counter” products.
Market Leading Gravimetric Feeding and Blending Solutions
With around 50 continuous blenders installed for pharmaceutical applications as well as over 125 years of process engineering know-how gained in other industries, Gericke is the global market leader in providing flexible and modular feeding and blending solutions for the continuous production of oral solid dosage forms. With exponential growth in sales over the last years 2021 marked another successful year with a record-breaking order intake. Systems ranged from gravimetric feeders and blenders integrated into isolators, semi-continuous blending for direct compression, modular units with eight gravimetric feeders as well as high volume lines supplying multiple double-sided rotary tablet presses. With installations all over the world: Germany, France, England, Scotland, Scandinavia, USA, India, South America, etc. it goes to show that continuous manufacturing is not only a trend and will soon become the paradigm shift everyone is hoping for.
Gericke Feeding, Mixing, Conveying, Size Control Technology. High-class workmanship for a world of industry. Gericke supplies conveying, sifting, high-precision feeding, and mixing solutions that handle a broad range of ingredients such as pellets, powders, floodable powders and fibreglass for food, chemical, industrial, and pharmaceutical industries.