What Is the Optimal Baseline Before Outsourcing Process Development?
May 2, 2019
A critical question facing companies considering outsourcing their process development (PD) is; What do I need to have in place before I look for a provider that can help me develop my process? Are you wondering… Do I have the expertise, the time, and the resources to develop my process internally?
Prior to initiating a search for a suitable partner, you should first carefully consider and evaluate the status of their overall process. This includes collating relevant information and data sets that will provide essential information to partners who are working to develop the process. These include:
- Safety data for the expression system
- Details surrounding the therapeutic molecule and reagents used
- General scientific knowledge of the therapeutic molecule
- Protocols and conditions used to generate the product
- Overall productivity and yields obtained in the current process
- Critical quality attributes of the resultant therapeutic agent required to be retained
- Analytical techniques and protocols used to evaluate product quantity and quality.
Choosing the Right Partner
The type of partner chosen will depend on the status of the process. For example, if a cell platform has not been chosen, or an expression system developed for the therapeutic molecule, a partner that has the capabilities to generate cell-lines and an expression system capable of producing your target molecule in a biologically active state should be sought. These groups will provide systems for expression of molecules to levels that will facilitate treatment of the targeted patient population(s).
There are multiple options from which to choose, and the platforms include stable protein-expressing mammalian cells, microbial systems, insect cells, and plant based cell-lines. Transient expression is often accomplished by using viral vectors and plasmid DNA-based systems that carry the gene of interest. For cell and gene therapy applications, the cells and/or recombinant viral vectors produced by the cells are harvested, purified and then used as the therapeutic moiety.
Often, groups seeking PD support have already developed a suitable small-scale expression system for their molecule of interest. However, their process currently employed is not optimized for acceptable yields, nor is it able to be translated into a scaled-up process. In these cases, a PD partner that has extensive expertise in optimizing and scaling processes in cutting-edge technologies can be the optimal choice. In this scenario, all materials used in the current process, along with relevant protocols are required. Protocols will be optimized by the outsourcing partner and adapted for industrialization of the process. Additionally, the general information mentioned previously will facilitate rapid development and expedite timeline. Failure to supply suitable materials results in unwanted delays and escalates costs.
Ruta Waghmare – Vice President, Scientific Affairs and Laboratory Services
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