New high-quality and affordable serotype-specific monoclonal antibodies (mAbs) now globally available to support vaccine manufacturers in the development of pneumococcal vaccines
PATH and the National Institute for Biological Standards and Controls (NIBSC) have partnered to house up to 29 new serotype-specific monoclonal antibodies (mAbs) reactive with pneumococcal polysaccharide commonly included in polyvalent pneumococcal conjugate vaccines under development. Fourteen high-quality and affordable mAbs (anti-PnPS 1, 3, 5, 6A, 7F, 8, 9N, 9V, 10A, 12F, 14, 18C, 19A, and 22F) are now available to globally support vaccine manufacturers in their development of affordable pneumococcal vaccines. An additional fifteen serotype specific mAbs are in late-stage development/production with anticipated availability at NIBSC by Q2 2022.
Pneumococcal pneumonia, a vaccine-preventable disease, is a leading infectious cause of death among children under 5. Vaccines are a critical strategy to protect children, particularly those in Africa and Asia, where over 90 percent of all pneumococcal deaths occur. However, barriers such as vaccine price and availability often prevent children in low- and middle-income countries from accessing these lifesaving tools. Furthermore, the current vaccines do not target all of the disease-causing pneumococcal serotypes for children in these parts of the world.
PATH is working with partners to advance the development of new pneumococcal vaccines that are low-cost, broadly protective, and tailored for use in low-resource settings. Providing high-quality and affordable reagents such as monoclonal antibodies will help to ensure that critical pneumococcal vaccines are affordable and accessible to children in low- and middle-income countries. NIBSC plays a major role in assuring the quality of biological medicines through the development of biological reference materials and standards. NIBSC is therefore the ideal partner as the repository and distribution center of the monoclonal antibodies to ensure open and affordable access.
The mAbs have been evaluated and demonstrate serotype specificity against a panel of 29 of the most common PnPS antigens. The panel of mAbs is available in 0.5 milligram quantities with a certificate of analysis provided.
These antibodies were developed with funding to PATH from the Bill & Melinda Gates Foundation and are available from NIBSC by visiting their online catalogue of biological reference materials.
“NIBSC and PATH have a shared interest and history in projects that have a public health benefit. To this end, NIBSC is delighted to be working alongside PATH to develop and supply these mAbs to vaccine manufacturers and the pneumococcal research and development community. The use of these antibodies will contribute to the development of new pneumococcal vaccines. We are incredibly grateful to PATH and the Bill and Melinda Gates Foundation for providing the material and the funding for this important project. By joining forces with PATH, NIBSC has been able to contribute its's world leading expertise in the production and distribution of biological reference materials and standards, to make these antibodies available,” states Dr Hannah Chan, senior scientist, Meningococcal and Pneumococcal vaccines group, NIBSC.
The National Institute for Biological Standards and Control (NIBSC) is a world leader in assuring the quality of biological medicines through product testing, developing standards and reference materials and carrying out applied research. NIBSC is a centre of the Medicines and Healthcare products Regulatory Agency which also includes CPRD and MHRA. The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.
PATH is a global nonprofit dedicated to ending health inequity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing public health challenges.