Vaccines are a group of products that includes some of the oldest biological pharmaceutical entities. They are also an area where new techniques and manufacturing technologies, many of which involve Pall products and processes, are giving rise to significant changes in manufacturing methods. Critical Aspects in Vaccine Processes Fermentation: safety and containment while culturing organisms that are potent pathogens, or handling toxins   Air and Gas Filtration Products Allegro™ Single Use Systems Harvesting and Inactivation: harvesting to ensure maximum yields, especially with labile viruses  Kleenpak™ TFF Capsules Downstream Processing: purification of active agents Chromatography Products Downstream Processing: removal of impurities and adventitious agents Contaminant Removal Formulation and Filling: maintaining potency and yield during sterile filtration of particle containing solutions and in the presence of adjuvants Fluorodyne® EX Filter Series

Single Use Devices for Vaccine Processes

Single-use devices and systems are ideally suited for vaccine processes as they:  

• require no cleaning or cleaning validation 
• reduce contamination risk with most components being preassembled and sterilized
• allow complete process flexibility
• are ideal for the smaller batches typically found in vaccine manufacture
• allow easy scale-up by multiplexing in the event that large volumes urgently become required
• maximize facility use by allowing multiple products to be made in a single suite without downtime between products

Vaccine Manufacturing and Pall's Capabilities

While eradication of some historic diseases has led to a lower need for prophylaxis, increasing need for seasonal vaccines for influenza, emerging diseases such as West Nile and SARS, the need for vaccines for widespread diseases such as Malaria, the development and approval of vaccines for conditions such as HPV, and the resurgent threat of bioterrorism has given impetus to finding new and rapid methods for producing vaccines.

Disease resistance of some strains of organisms, such as tuberculosis, difficulties in providing vaccines suitable for immunosuppressed patients, as well as the need to provide vaccines to greater numbers of people at lower cost, are all challenges facing manufacturers and governments alike.
There are many types of vaccines. Links on this page will take you to descriptions of processes and Pall products ideally suited to ease vaccine manufacture.

• rProtein, protein and ploysaccharide Vaccines
• Microbial Vaccines
• Plasmid Purification and Gene Therapy
• Viral Vaccines and Vectors

The many types of “vaccines” are summarized in the links below with examples and a brief historical perspective, and then the current and potential future uses of conjugate vaccines are discussed. Information is presented on manufacturing techniques for some of these conjugate products. While vaccines are used prophylactically, some vaccine techniques and technologies are being used to address therapeutic applications, such as the treatment of certain cancers.

• Classes of Vaccines
• Manufacturing of Conjugate Vaccines 

Useful External Links

List of vaccine preventable diseases:  http://www.cdc.gov/vaccines/vpd-vac/vpd-list.htm
List of vaccines used in the United States: http://www.cdc.gov/vaccines/vpd-vac/vaccines-list.htm