Biopharmaceuticals - like the vast majority of small molecule drugs – must be combined with excipients if they are to change from being a promising laboratory candidate, through clinical development to become a product on the pharmacy shelf.
Indeed, the additional complexity of stabilizing large biological molecules compared with traditional chemical drugs means excipients are arguably even more important to biopharmaceutical products.
So finding a reliable supplier is as important for Biopharmas as it is for small molecule drug developers. And this is the problem according to FinnBrit’s Christian Moreton, who told Bio-Pharmarerporter.com that, for Biopharmas, there are only a limited number of sources.
“The main challenge at the moment is that biologic drugs must be given by injection. Whatever excipients are required to manufacture the finished product, either as a solution, or as a freeze-dried cake for reconstitution, must be suitable for use in parenterals”
This – Moreton continued – means the excipients used in biopharmaceuticals need to be free of pyrogens –bacteria derived compounds which can induce fever - and sterile because most large molecule products are produced in aseptic conditions.
“The challenge in many instances is to identify a supplier; because of the small quantities required, many manufacturers may be reluctant to invest in the manufacture of sterile, pyrogen-free grades of their excipients”
In time, Moreton suggested, new biopharmaceuticval delivery technologies and formulations may make such difficulties a thing of the past, but biopharma relief may be short lived.
“When we get to a reliable means of delivering biologic drugs via the oral route, there will be different challenges.”