BioPharm International - February 2020

BioPharm-Outsourcing eBook

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www.biopharminternational.com February 2020 BioPharm International eBook 11 as a result we have seen a number of innovative new companies formed to address these pain points. Many com- panies across different functions are working together to address the chal- lenges in the delivery of these thera- pies from cryopreservation logistics through to patient support services. It is this collaboration between out- sourcing partners that is addressing some of the challenges. BEST PRACTICES BioPharm: What advice would you give companies seeking an outsourc- ing partner for CGT development? Lakelin (TrakCel): It goes without saying that a demonstration of good practices is essential when considering outsourcing activities in ATMP devel- opment. Regulatory requirements often set the starting point in a ven- dor selection process. Additionally, it is certainly advisable for companies to select an outsourcing partner that can demonstrate a good understanding of technology transfer. Each manufac- turing process is bespoke with CGT, so the ability to execute often complex manufacturing cycles is essential. Nyamay'antu (Polyplus-transfection): The introduction of any starting or raw/ancillary material in the manu- facturing process of viral vectors is a risk in itself. It is therefore essential for companies to judicially choose out- sourcing partners that evaluate each raw material individually through a risk-based approach. To mitigate risks, more and more outsourcing partners are choosing to use essen- tially GMP-compliant raw material. Manufacturing GMP-grade raw mate- rials ensures that the manufacturing process has been validated. As such, companies can be confident that quality and safety are ensured to meet regulatory agencies requirements. Forte (Bone Therapeutics): The first aspect is for the companies to know and own their technology, process, and product. This is critical for the success and control of your product development and business viability. Second, the correct selection of your partners is vital, both on the com- petencies and 'hard skills' aspect but also on the aspect of cultural fit and 'soft skills'. This will ensure adequate technical performance and good team collaborative working spirit to face the development challenges and tight timelines. Make sure there is good integration between orga- nizations and a good project man- agement. This aspect is also of vital importance for success. One additional aspect to be con- sidered in outsourcing partnering is risk-sharing. In some circumstances, particularly in early stages with low cash flow but high potential projects, the insourcing organization, and the outsourcing organizations may bene- fit by sharing the costs, the risk, and, consequently, the returns on the proj- ect. This may make financial sense, enable a short-term project, and solid- ify the partnership. Finally, make sure your organiza- tions, both the insourcing and the outsourcing, engage in constant train- ing, update, exchange of information, and experience through the network. WHAT NEXT? BioPharm: What trends do you predict will impact outsourcing within CGT in the coming decade? Forte (Bone Therapeutics): I believe there will be an increase in outsourc- ing as organizations, particularly start-up companies, will be more vir- tual and take advantage of provid- ers with knowledge and the technical and financial ability to conduct the activities needed for those companies. It makes clear sense to own the tech- nology and the know-how but take advantage of the flexibility and finan- cial advantages of outsourcing. Providers will expand and deliver services that will be both broad as well as specialized but covering a wide range of offerings. Only very large organizations will keep most of the functions in-house and even these will take advantage of the avail- ability of expert focused capabilities that can deliver services flexibly and cost-effectively. Lakelin (TrakCel): I would anticipate continued innovation in manufac- turing technologies. Automation has been demonstrated to show bene- fits in the manufacturing process already, and there is certainly more and more interest in emerging tech- nology areas such as big data and artificial intelligence. Furthermore, I would expect to see a move towards standardization within the CGT industry. By establish- ing more consistent practices across manufacturing, logistics, compliance, and many other areas, the industry will be able to overcome some of the current growing pains it is experienc- ing. The ability to harmonize many of these components will push the industry forward and more impor- tantly, get the right treatments to the right patients globally. BP Partnerships for Outsourcing Development "By establishing more consistent practices across manufacturing, logistics, compliance, and many other areas, the industry will be able to overcome some of the current growing pains it is experiencing." —Matthew Lakelin, TrakCel

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