In preparation for the Fundamentals of Extractables and Leachables training course taking place this October, we sat down with one of this year's featured speakers, Dr. Daniel Norwood, to discuss what's going on in the field of E&L.
With over 41 years of experience in chemistry and pharmaceutical research, Dr. Norwood is well recognized in the industry as one of the pioneers in E&L research. He has served on the Board of the Extractables Leachables Safety Information Exchange (ELSIE), and is a member of the USP Packaging, Storage and Distribution Expert Committee, where he chairs the subcommittee on extractables and leachables.
What are some challenges you are currently facing in the industry?
Norwood: The industry is still facing challenges about how to deal with accomplishing E&L studies, how to actually design and do simulation studies, and when and if actual leachable studies are required on various types of drug products. In particular, the biotechnology industry is relatively new into the E&L business and they’re concerned about things like single use bioprocessing equipment and so on. There is still some uncertainty around how to deal with these issues in the biotechnology industry.
The uncertainties in the industry are being dealt with by standard setting authorities such as the US Pharmocopeia (USP) and other industry consortia for biotechnology in particular – the BPSA (which Smithers is a member of) and BPOG - where new standards and guidance’s are being developed – likely in the next 5 years will eliminate some of the issues concerning the industry right now
There is still a reasonable amount of regulatory uncertainty – the FDA learns from industry – there is a back and forth process that is continually ongoing with the FDA (a lot of consensus building processes that have been ongoing) – these things are not fast.
Do you see the current administration having an impact on the E&L industry?
Norwood: The new administration is not going to have any foreseeable effect on the pharmaceutical packaging industry – but it has had an effect on the electronic nicotine delivery systems (e-cigarette) industry, which is also concerned with E&L studies –the FDA extended certain tobacco product compliance deadlines related to the Final Deeming Rule.
If there is any other area affected by the current administration, it will likely involve the issue of importations around China and India. It's possible that certain importation standards could change, but it’s far too early to know or speculate what the impact would be.
What types of innovations would you like to see within E&L?
Norwood: Personally, more innovations from instrument companies that enable them to do a better job identifying and quantifying E&L. Actually, this is starting to happen. Various libraries are being developed by the instrument companies, and various other organizations are developing libraries as well. Some of these libraries are proprietary and you have to pay something or join to be a part of them – but we are moving in the right direction.
Authentic reference standards would be extremely useful to the industry in general.
What can you gain from attending?
Norwood: Smithers has a signicant amount of expertise in E&L characterization and a number of Smithers employees have been involved in the development of best practices and standards of E&L – pharmaceuticals, electronic nicotine delivery, etc.
By attending this training course, you will have the chance to receive personalized guidance on regulations, best practices, and testing standards fom respected industry experts that are performing the studies in the labs.