Expediting the Technical Transfer of Biopharmaceutical Products

Proper infrastructure ensures equivalent analytical results at all laboratories for a successful simultaneous commercial release from various sites.
Sep 02, 2006

One of the challenges faced by the pharmaceutical industry in today's global economy is the successful release of commercial drug products in multiple markets.

When the commercial release of a drug has to be accomplished simultaneously from different sites, the establishment of the proper infrastructure ensures equivalent analytical results across the various laboratories.

Thoughtful coordination and implementation of the highest quality standards involves expert training, compliance with established standard operating procedures, analytical methodology, validated instrumentation, availability of critical reagents and reference standards, and a uniform materials and documentation practice across analytical laboratories. The result is a successful technical transfer of products.

Particularly challenging is product release of commercial biopharmaceuticals. Careful planning and preliminary considerations ensure a successful technical transfer.1-6 In the case of biopharmaceuticals, analytical methods are often quite complex. For commercial product, the methods are fully validated and the biopharmaceutical product has been well characterized by the originating laboratory.7

Quick Recap
As a case study, the experience of Wyeth Research in the successful technical transfer of bioanalytical product release methodology to the Japanese and European markets is discussed.

Analytical Training. The goal is to provide adequate training to the receiving laboratory analysts and ensure compliance with procedures established by the originating laboratory while minimizing variability in analytical results. This will likely entail direct training by the transferring laboratory. Established, fully validated methodology and SOPs are required before initiation of any training activities. Coordination of training requirements among sites must include verification of equivalent training practices while considering each site's unique needs. Additionally, qualifications of the analysts to be trained must be documented.

In our own experience, a visual training presentation was instrumental in overcoming unexpected language barriers.

Regulatory and Compliance. All documentation encompassing validation of analytical methods, SOPs, reagents, certificates of analysis/origins of materials, instrumentation equivalence, equipment qualification status, personnel training, and facilities certificates must be reviewed and compiled in compliance with regulatory agencies from both ends of the transfer. In the case of biologicals, additional safety parameters, such as biohazard exposure and adequate training of personnel in biomaterials handling, are essential. Regulations pertaining to the licensing permits and qualifications of the receiving laboratory in handling items such as radioactive materials or biohazard or pathogenic materials also must be examined and may vary on a case-by-case basis. Procedures must be verified to meet compliance requirements with national regulatory agencies governing the receiving laboratory.

Safety. The primary responsibility of the releasing analytical laboratory is to produce the highest quality data and corroborate product integrity, thereby ensuring the safety of patients receiving a drug product. It is essential that the releasing laboratory acquire not only pertinent analytical methodology, but also develop scientific expertise and become fully acquainted with all aspects of the drug characteristics prior to release to the public. Open communication channels must be established to ensure that adequate knowledge about the drug product is transferred from the originating laboratory to the receiving laboratory during and following completion of the technology transfer training activities.

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