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Modern filling lines to handle PFS for pandemics
November 9, 2012
By: Dr. David
Vetter Pharma International GmbH
The vaccine market is experiencing a period of renewed interest driven by novel opportunities in areas of unmet need. In the coming years, the pharmaceutical industry is expecting significant growth in the vaccine market segment. But many of the new complex biologic-based vaccines are challenging to produce. Therefore, new solutions are needed to take advantage of this rapidly evolving market. Drug manufacturers can actually benefit from the established know-how and capacities of leading contract development and manufacturing organizations (CMDO) to deliver secure supply for public health. For some time, it seemed as if the vaccine market of the typical pediatric and flu vaccines had matured. Recently, however, the segment has been revived due largely to advances in research into the human immune system and pathogenicity. Also, the successful introduction of several new and highly effective vaccines has boosted confidence. Industry analysts like RNCOS expect continuous growth in the coming years. In fact, the RNCOS 2011 Global Vaccine Market Forecast predicts sales growth of almost 20% to about $33 billion by 2013. The best opportunities for drug manufacturers will be in areas such as nosocomial infections, therapeutic vaccines and pandemics. But while the outlook is positive, there continue to be a number of challenges ahead. Modern substances that stem from biotechnological processes have more challenging requirements when it comes to production, manufacturing, and administration. Until recently, the main players had made only limited investment in future technologies in these particular areas. Therefore, to help bridge the technology gap, many pharma firms in the vaccine space are looking into contract manufacturing to take full advantage of the comprehensive know-how and high capacities of leading CDMOs. With their innovative manufacturing facilities, such service providers can realize potential solutions for this emerging growth segment. Setting Up a New Premise While the established markets for pediatric vaccines and influenza have become increasingly saturated, new biotechnological methods for producing vaccines for complex pathogens like meningitis, hepatitis C, cancer, and HIV are providing new sales growth. The specifications for these substances and their areas of application are giving rise to entirely new packaging and manufacturing processes. Sensitive substances, for example, require extremely high quality and safety standards in production. However, because of the high value of the substances, the trend is to shift away from vials and move towards prefilled syringes. In today’s global world, the risk of pandemics is omnipresent and thus, public vaccination programs are increasingly demanding prefilled syringe use. The outbreak of H1N1 in 2009 demonstrated quite well how the lack of speed in vaccine filling could be a potential weak point in effective combat against dangers. In the case of a pandemic, as many as 300 million people in the U.S. alone would need a jab. For the health authorities and emergency management organizations, such numbers represent an enormous challenge. Multi-dose vials need more time and trained personnel for administering the vaccine if accidental “stick” injuries are to be avoided. As such, many emergency agencies prefer prefilled syringes as an option for vaccinating large numbers of people in a short period of time. Looking to the immediate future, vaccine manufacturing plants must be able to produce large quantities within a few weeks while maintaining high quality and safety standards. And because the “blockbuster model” of drug manufacturing is largely in the past, the old monoplant model is no longer relevant or economically feasible. Therefore, today’s CDMOs must be flexible, allowing for a simple product changeover. For the pharma company, avoiding loss of expensive antigen is another important issue. Because they are already meeting stringent requirements to work safely and efficiently for their customers in other areas, CDMOs are in an excellent position to provide answers to this challenge. By collaborating with a top engineering firm, a CDMO can develop a high-speed filling line conceived specifically to meet the complex demands of vaccines. A Special Approach for Vaccines As the prefilled syringe market becomes more established, pre-sterilized injection systems have now become an accepted alternative to bulk systems. However, the entire process has to be maintained at a high aseptic level — never a simple task. The decisive question is how to introduce the tubs and the syringes into the critical area for filling. For an illustration of what a solution for vaccine filling should look like, let’s look at our newly built high-speed filling line.
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