In this week’s news, concerns about drug shortages, US FDA called on to give better excipients guidance and more…
Old plants and metrics threaten drug supplies, say experts
The risk of drug shortages is increased by industry’s reliance on ageing facilities and inappropriate quality metrics according to research.
A study in the American Pharmaceutical Review last week looked at the causes of supply issues. One of the key findings was that medicines made in older plants were more at risk than those produced in modern facilities.
According to the authors, “The concern with older facilities and manufacturing lines is that it is hard to predict when they will cease to be capable of producing high quality products to the market. While the lines may run smoothly for a time there are hidden issues that will eventually emerge causing the line to malfunction potentially creating a drug shortage.
“The older the line the more likely it will experience frequent interruptions and breakdowns. Production interruptions will be more common and the costs to remediate these issues will continue to rise. In some cases, replacement parts may be needed but could be difficult to procure,” they add.
Analytics are also an issue. The authors suggest industry needs to rethink its approach to measuring quality to prevent supply interruptions.
“Some of the analytical procedures used to determine the suitability of the product are outdated and, as with the production equipment, replacement parts can be difficult to find. In some cases, the chromatographic columns needed for analysis are no longer available.
“Breakdowns and older equipment issues associated with laboratory operations can contribute to the inability of a company to release product in a timely manner which can result in a drug shortage” the authors add.
Read the full study here.
Industry asks US FDA to expand and clarify excipients database
Drug firms and industry groups have asked the US FDA to expand its list of inactive ingredients.
In July the US regulator issued recommendations for firms using its online repository of information about excipients.
The agency specified that companies can reference inactive ingredients in applications as any excipient used in an approved product is “not considered new and may warrant less extensive assessment the next time it is included in a new drug product for the same route of administration.”
But more information and clarification is needed according to various companies and industry groups that wrote to the FDA last week.
For example, International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) says too much of the information is regulated to footnotes.
Meanwhile the Association for Accessible Medicines (AAM) said it would like additional guidance on how to justify the use of an excipient when its proposed use differs from the referenced IID listing.
In its comments AbbVie said the guidance should include biologics license applications (BLAs). Likewise Gilead said “it would be helpful if an acceptable update schedule for the database could be defined.”
Also in the news
The Wall Street Journal wrote about German drug maker Merck’s efforts to use machine learning to predict demand for its products.
The US FDA issued a statement on its efforts to increase patient access to generic medicines. See here for more details.
The US is thinking about imposing tariffs on Swiss made drug imports according to a report in Neue Zurcher Zeitung.
The EMA’s drug review committee the CHMP has recommended the approval of Merck Sharp & Dohme B.V’s Ebola vaccine. See the statement here.
Some developments of note in the contract manufacturing sector.
Tedor Pharma has been contracted to make a combination insomnia drug being developed by Sequentiual Medicine. The firm will supply the drug for Phase II clinical trials.
Lonza is looking at the expanding Chinese CDMO sector according to Bioprocess Insider. CEO Mark Funk explains the firm plans to become a “major player” in the country.
China’s BJ Bioscience has partnered with contract manufacturing firm CMAB. The collaboration will focus on the former’s candidate antibody-based drug, BJ-005.