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By Dr. Jérôme Freissmuth
Managing High-potency Substances
The use of high-potency pharmaceuticals has grown extensively, causing manufacturers to pay more heed to protecting all elements of the supply chain from their potentially harmful effects. Particularly in the past 10 years, containment has steadily moved up the agenda for drug manufacturers and will continue to do so. Advances in oncology and immunology have led to increased use of highly potent and cytotoxic substances in the treatment of cancer, and hence new challenges in the containment of these substances. In the supply chain, both workers and the drugs themselves are at risk if containment technologies are not applied effectively. Also, for high potency drugs such as hormones, Good Manufacturing Practice guidelines require dedicated facilities to minimize the risk of cross contamination.
The handling of highly potent drugs is therefore built around the principle of protecting drugs and employees from contact with each other, with as little manual intervention as possible. The latest equipment solutions favor the use of automation and robotics technology to reduce human contact with any substances that are being manufactured. As a result of the increasingly strict guidelines from regulators, manufacturers increasingly rely on the use of barrier technology such as isolators.
Barrier Technology allows fully enclosed, sealed and pressurized units completely separated from operators. They offer far greater sterility assurance than conventional cleanrooms, and can significantly lower costs associated with more traditional filling and finishing methods. The most advanced, closed restricted access barrier systems (cRABS) contain toxic compounds, usually in their use of positive pressure and air filtration systems within the chamber. Technological advances in air suits, gloves and sleeves further diminish the risk of cross-contamination. Automated cleaning features allow for machine parts to be cleaned without manual disassembly, and give employees greater protection from potentially harmful substances.
Producing Small Batch Sizes
Although personalized medicine still is at an early stage of development, targeted drugs that take account of genetic variations will allow large numbers of patients to receive highly individualized treatment in the near future. Personalized medicine will continue to demand ever more flexible and versatile processing and packaging solutions. Smaller batch sizes shift the emphasis from speed and mass production of standard dosage products to more individualized products packaged in high-quality materials. Short start-up times, easy changeovers and a high degree of automation are key considerations.
Before being introduced to the market, personalized medicine requires a great research and development effort. Devised on very small laboratory equipment, the recipes need to finally be transferred to production-scale machinery. However, manufacturing lab equipment is highly complex and costly. New machinery developments demonstrate the possibility of covering almost the entire manufacturing process in one single machine, thereby dramatically reducing investment costs. From research and development via scale-up to industrial production scale, manufacturers strive to reduce time to market. Laboratory processes can be optimized by implementing small and flexible machinery. Key production parameters are clearly defined and allow for an easier transfer from lab to production scale. Recently developed software is now able to calculate the required process conditions and, hence, to considerably save time. Numerous trials provide scientists with the required information to transfer small batch trial results to large production machinery.
In the fast-paced pharmaceutical market, it is difficult for manufacturers to anticipate which products will be required next. Therefore, new machinery must be future-proof, have scalable and flexible platforms, and be adaptable to new products, characteristics and formulations. These solutions are supported by the enhanced use of pre-sterilized packaging styles like syringes, vials and cartridges. With their flexible platforms, “state-of-the-future” machinery is capable of processing many different containers. Moreover, equipment providers will be well-advised to increase their services in terms of formulation and development support. This service can range from operator training sessions for a trouble-free deployment to the rental of entire laboratories, including personnel and equipment, for the development of galenic formulations. The data generated in these test runs must be suited for an easy scale-up to the customer’s own production equipment.
Utilizing Single-use Components
The demand for greater flexibility and the elimination of possible contaminants will find another effective ally in the form of single-use components. This trend is a consequence of industry safety regulations, growing use of highly potent substances, and a shift towards smaller batch sizes. The time-consuming process of cleaning, sterilization and validation of product contact parts, particularly during changeovers, has long been a hindrance in achieving operational efficiency. Single-use, pre-validated, pre-assembled and pre-sterilized components including hoses, product bags, filling needles and tubing mitigate inefficiencies and can eliminate the capacity losses resulting from lengthy cleaning validation as well as the risk of contamination between batch runs.
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