Vaccine Manufacturing Reborn

By Angelo De Palma, Ph.D., Contributing Editor After years of suffering as the pharmaceutical industry’s stepchild, vaccines are regaining their rightful place as wonder drugs, and profitable ones at that. Emerging indications, worldwide markets, and premiums supported by innovative manufacturing have set the stage for a vaccine renaissance. “Our biggest challenge in continuing our growth will be expanding our manufacturing capacity over the next four to five years, and obtaining approvals for the many vaccines within the major markets which are increasingly global,” comments John Picken, VP for industrial operations, North America at GSK Biologicals (Laval, Québec). It is common for vaccine manufacturers to seek approvals simultaneously in their countries of domicile and overseas. GSK believes its future vaccine successes lie with novel, biological adjuvants. Pipeline products containing these new immunostimulants include Cervarix, which uses a biological adjuvant produced through fermentation. The adjuvant used in Cervarix is already incorporated into another vaccine marketed in Europe. Although biologically “adjuvented” vaccines are approved as single products, each component commands its own manufacturing and purity controls, and the adjuvants must pass regulatory muster. Even though their manufacture is straightforward, biological adjuvants are unfamiliar to regulators as well as to their developers. The impact of adjuvants on vaccine efficacy and in conserving manufacturing capacity is substantial. Early vaccines for pandemic flu lacking an adjuvant required two 90 microgram doses to induce an immune response. By adding adjuvant GSK vaccine reduced the effective dosage to 3.8 micrograms. “If the vaccine industry had to produce a flu vaccine that required 90 micrograms per dose we would never have enough capacity to supply the market’s needs,” Picken noted. GSK observed a similar effect with its malaria vaccine. Sixty-five percent of GSK’s vaccine pipeline depends on adjuvant systems. At one time the word “adjuvant” was synonymous with alum and