As vaccine manufacturers turn their focus to emerging markets, several technical and logistic hurdles remain to be overcome.
On Day 3 of the 2010 World Vaccine Congress in Lyon, France, Helge Berg, Director of the European Biomanufacturing Science Network at Merck Millipore, discussed the changes in the vaccine research and manufacturing industries that are driving the movement of vaccine research, development, and marketing processes from the traditional European and North American markets to the emerging markets of South America, India, and Southeast Asia. He said that one obvious reason for this is “the need to serve growing populations with life-saving vaccines as locally as possible.”
Vaccine technology transfer (VTT) is a complex process. Berg said his company “has a track record of providing focused support to the vaccine market over many years, through the establishment of a dedicated vaccine program.” The company also created the Biomanufacturing Science Network, a global network of 75 scientists and engineers that supports more than 100 highly technical vaccine industry projects each year. Berg said the projects cover “everything from process development through scale-up, from optimization to implementation at manufacturing scale and troubleshooting.” The Biomanufacturing Science Network team “develops and fosters trusted relationships with key process developers and manufacturing engineers in the biopharma and biotech industries, acting as an extension of the biopharma company teams, creating scientific and technical synergies,” Berg said. The mission “is to add value to the technical pursuit of these industries, seeking to develop and implement robust process sequences that significantly reduce risk of failure and thus ensure peace of mind.”
Berg also discussed the challenges encountered by the industry when performing VTT in emerging markets in terms of qualified local staff, supply chain, Copy Exact (no matter how “exactly” SOPs are maintained, glitches may occur), and communications. To be effective, VTT must be supported by a structured approach that focuses on building technical teams under a dedicated project management structure, connecting with key stakeholders at the sending and receiving units, and building skills and training local staff to support consultancy on site. Berg said that the key is to “mitigate risk through the ability to bring in people with the right skills at the right time to ensure process robustness and peace of mind before, during, and after the VTT has taken place.”
Merck Millipore’s unique value proposition to the biopharmaceutical and biotech industry lies in the local presence and deployment of a globally networked organization that is able to mitigate process risks through the use of expert scientists and engineers who support all VTT phases and train relevant operators and managers, “local” warehouses in key areas, and connections with local markets (authorities, engineering houses, etc).
Berg concluded by outlining several key considerations for the industry as it pursues future vaccine development projects. He said that it will be important to: