A Qualitative Study Among Potential Manufacturers on the Development of 'Made in Malaysia' Biological Products: Challenges and Proposed Solutions

摘要

Aim: To examine the challenges in development of biological products among Malaysian pharmaceutical manufacturers. Methods: We conducted in-depth interviews (IDIs) with senior management of five local pharmaceutical product manufacturers from December 2015 to September 2016. We performed a purposive sampling focusing on local pharmaceutical manufacturers with existing sterile manufacturing facility and known intentions to develop biological products. Audio recordings were transcribed verbatim and coded, with common themes identified and analysed. Information provided by participants was verified with a policy maker. Results: Participants were generally apprehensive in viewing the sustainability of a local bio manufacturing industry, despite the availability of various government incentives. Our research uncovered some common themes on challenges in developing 'Made in Malaysia' biological products. These include: lack of technical capacity (know-how) in bio manufacturing, lack of understanding on regulatory requirements, susceptibility to litigation by originator biological product manufacturers, limited commercial viability of Malaysian biological products, and a fragmented government support system. Through our discussion with participants, some solutions to encourage a thriving bio-based industry in Malaysia through public and private contributions, are proposed. Conclusions: There are genuine challenges to be addressed by local pharmaceutical manufacturers and policy makers in working together to develop a biopharmaceutical industry in Malaysia. From product research and development to commercialisation stage, public and private partnership towards commercial sustenance of'Made in Malaysia' biological products is key to our country's vision of a successful bio manufacturing industry.