Prerequisites

• Check current IPR situation in order to avoid any infringement of intellectual property rights.
  
• Collect basic data about your target molecule such as MW, pI and stability in order to select proper conditions for the downstream procedure.
  
• Study the literature. There can be useful advice from earlier research. However, note that many lab methods are not scalable.
  
• Have efficient and accurate analytical tools in place. Downstream process development requires established analytical tools with the proper accuracy and turn around time. Do not forget a relevant bioassay. All methods have to be validated.
  
• Resources. Check that equipment and skilled personnel will be available at the time you plan to use them.
  
• Feedstock. A consistent starting material is essential to avoid having to re-work methods later on. Instability in the expression system, variation in impurity profile, variability in glycosylation, etc. have major impact on the downstream process.
  
• Gather the latest guidelines, rules and recommendations from the regulatory authorities