You have been hired as an external consultant to a contract manufacturing organisation (CMO). They have recently decided to expand into offering onsite formulation and fill finish production services to complement their upstream and downstream production capabilities. They require more knowledge on this area and therefore they are recruiting external experts.
1. You have been contracted by the company to research the most appropriate routes of administration for biological medicinal products available at this time. After analysing the current routes of administration and novel approaches, you must evaluate the advantages and disadvantages of each route. From your evaluation, recommend a preferable biological drug delivery method.
2. A client of the CMO has enquired regarding methods of extending stability of their biological products improving both shelf-life and therapeutic half-life in the patient’s body. There may be methods of manufacturing and/or formulating available to the CMO to improve the protein chemical and physical stability. After analysing common methods used to enhance product stability (formulation and dosage form), you must evaluate the preferred method(s) available. From your evaluation, recommend an approach to achieve stability improvements as requested by the client.
The projectis expected to comprise of information from outside the course material including scientific journals, publications, and industry focus websites. The recommendations must take into account cost, patient safety, regulatory requirements and technology limitations. I only want the second part (2) but is related with part one and the route of administration is parenteral.And the method used have to be Freeze dryng/ lyophilisation. This is about biopharmaceuticals and not pharmaceuticals.