"As a way of introduction into this column, I should explain my background within the industry and what I would like to achieve. I have been working in the biotechnology & pharmaceutical industry for over 28 years. Initially I began working within the blood fractionation industry, before moving into biotechnology development with large pharma and then joining a start up gene therapy company 18 years ago, beforefinally moving into contract manufacturing about 13 years ago.
Throughout this time, I have been involved in process development and manufacturing of new clinical entities and I have to date worked on over 40 new clinical products. Many of these have tended to lie outside of mainstream product areas such as monoclonal antibodies (mAbs). I have also worked on a range of new protein products, including antibody toxin conjugates, bio-similars, synthetic proteins, plasmid DNA, recombinant viruses, bacteriophages and whole cell microbial vaccines and therapies. Additionally, I have a long term interest in single use systems, both from a user perspective, and also from a business perspective in terms of the new solutions and methods they offer with regards to developing manufacturing approaches and the delivery of materials to the clinic. I have presented at a number of meetings in the area and published a number of articles.
Initially I want to concentrate on single use systems, however, my interest in this field isn’t so much in the technical merit of one system or approach than another, but to look at how this technology can be applied to delivering products to the clinic and how development groups can improve the service they offer to their “customers” in drug development. I will expand this scope and look at the whole area of taking new clinical entities from the research bench into the clinic and the challenges that lie in this area.
As the industry goes forward, it is clear that companies are looking to replenish and expand product pipelines and are relying on biotech products to achieve this. Companies are also looking to broaden their approaches outside of Mabs, so there will be increased demands on process development groups to be able to convert new and novel products from the R&D bench into clinical products. To me this is a critical challenge which the industry will have to address; not just looking at the use of innovative technologies such as single use systems to reduce development times and costs, but also to produce pioneering products such as stem cell therapies, as well as considering issues such as the relationships between drug development and manufacturing groups and the skill bases in process and analytical development that are required to be able to convert new ideas into reality.
We need to re-evaluate how we as an industry can respond to these challenges and I will try to address these issues over the coming months: I will look at where I see opportunities for future developments in single use systems, the pro and cons of off the shelf platform manufacturing processes and issues with regards to skills and training within the industry. I am very interested in hearing your thoughts and experiences on this area. You can email me at firstname.lastname@example.org"
Pharma IQ: Making Tomorrow's Medicines