Oral Solid Dosage Forms
GEA supplies engineering services, process equipment and technologies for the production of oral solid dosage forms to customers in the life science industries. Activities include partnering with customers to develop new products and enhance clinical effectiveness, the supply of R&D-scale and standalone production equipment and completely integrated production lines.
We provide proven solutions for the most challenging dosage forms, such as oncology drugs, MUPS tablets, effervescents and multi-layer pellets, as well as granules, dragées, crystals and pellets, modified release formulations, solid dispersions for bioavailability enhancement, powders designed for direct tableting or capsule filling, cytostatics and oncology medicines, hormones and antibiotics/anti-infectives. As containment experts, we not only offer the largest variety of solutions for contained processing, but also unrivalled experience in identifying the most appropriate solution based on a containment risk analysis.
From Powder to Coated Tablet
No other supplier offers the complete range of tableting technologies, from powder handling to granulating, drying, compression and coating, including the first ever continuous high shear granulation, drying and tableting system, which is set to revolutionize oral solid dosage processing.
GEA's entire range of process equipment is designed with system integration in mind. A modular approach allows customers to select standard process modules to suit project needs. Fluid bed dryers and coaters can be combined with top-drive and bottom-drive high shear mixer/granulators, wet and dry milling facilities, product handling systems, binder and coating preparation units, filtration units, tablet presses, all designed for fully integrated systems. Safety, containment, product flow and building requirements are in-built for full integration for optimum process efficiency.
The Future of Pharmaceutical Production
The development of agile, continuous manufacturing (CM) systems will be one of the most significant changes in the pharmaceutical industry in the next 10 years. Flexible development options will facilitate the commercial manufacturing process and enable greater process understanding to be achieved with smaller quantities of material.For more than 20 years, the batch-based production of blockbuster solid dosage forms dominated the industry. Profitability was such that companies were not incentivized to innovate or risk developing new manufacturing technology. However in the post-blockbuster era, it is increasingly recognised that material costs during drug development are significant, new drug products are likely to be manufactured in much smaller quantities and that, for novel treatments, the development of a commercial manufacturing process is not guaranteed.
Such pressures have put the costs, risks and timelines associated with traditional batch-based development and manufacturing under scrutiny. In most industries, CM is seen as the low-cost solution to producing low value, high volume products in which there is little need to focus on the cost of materials used in process development and, often, little need for product changeover.
However, the opportunity to obtain more data from less product during development and eliminate the cost and risk of batch-based “scale-up” has inspired the introduction of small-scale, continuous equipment that can process small quantities of material during R&D while also being able to operate for variable lengths of time to match market demand during commercial production. Regulators are increasingly supportive of CM and manufacturers are recognizing that current quality assurance costs are disproportionately large compared with other industries, wherein the production, detection and removal of out-of-specification product is vanishingly small.
Potential API savings of more than 60% and time-to-market reduced by more than a year have been identified by companies using small-scale CM systems. In 10 years, the vast majority of tablets will be produced on CM lines that are installed in modular facilities that are a fraction of the size of current plants.