capability to perform and control technically complex manufacturing processes—not an easy undertaking. This will require a variety of collaborative ventures between and among developed- and developing-country vaccine makers. Public-sector manufacturers in the developed world could play a useful role by facilitating these interactions. The International Vaccine Institute, recently established in Seoul, Korea, has as one of its goals the promotion of public-/ private-sector collaboration in vaccine development, with a focus on the needs of developing countries in Asia.

According to one proposal, the elements of a successful vaccine technology transfer effort will need to address strategic, scientific, training, and licensing issues (Table 5). The strategy of combining conjugate vaccines with DTP is now seen as the best approach by those involved in the CVI. Having highly purified D, T, and P may allow these components to serve as carriers in the conjugate vaccines, and simplifying the conjugation process will increase yields and reduce costs. Vaccine staff in developing countries will need training in practical subjects (good manufacturing processes, quality assurance and quality control, production methods, animal testing, serology, computerized record keeping) as well as theoretical topics (polysaccharide and protein chemistry, microbiology, and biostatistics). Such training might involve partnerships between public- or private-sector vaccine manufacturers in the United States and other industrialized countries and university or government laboratories in the developing world. Bilateral manufacturing agreements, allowing access to vaccine production knowhow and patented technology, would be essential.

TABLE 5 Vaccine Technology Transfer to the Developing World: Elements of a Solution

Strategic (CVI)

  • Combination vaccines with DTP

Scientific (manufacturers and universities)

  • Use highly purified diphtheria, tetanus, and pertussis components

  • Simplify and increase yields of polysaccharide-protein conjugation

  • Maximize immunogenicity of both pertussis and protein in conjugates

Training (manufacturers and universities)

  • Good manufacturing practices

  • State-of-the-art production methods

  • Clinical investigation

Licensing/technology transfer (manufacturers)

  • Bilateral agreements

SOURCE: Siber, 1994.



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