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
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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.
