In this week’s news, FDA confirms first SARS-CoV-2 related drug shortage, EC redrafts sterile drug manufacturing rules and more…
US FDA confirms SARS-CoV-2 related shortage but can’t name API firm
The US FDA has been notified of a drug shortage resulting from disruption caused by the SARS-CoV-2 outbreak in China.
The US regulator confirmed it had been made aware of the shortage last week. However, it did not name either the product of the API supplier involved.
The FDA told RAPS “While manufacturers are legally required to report drug supply disruptions to FDA, they are not required to provide the detailed information on their supply chain that we have needed to monitor the drug supply since the onset of the outbreak.
“We need the cooperation of the drug companies in order to obtain accurate information as we proactively take steps to mitigate drug shortages, and companies will be less willing to provide this voluntary information if they cannot trust FDA not to disclose commercial confidential information such as drug names, company names or exact location of facilities.”
Concerns the SARS-CoV-2 outbreak would impact drug supply chains were raised shortly after the virus was first detected.
The epicentre of the outbreak – Wuhan, China – is a major manufacturing hub for active pharmaceutical and finished pharmaceuticals.
CDMOs still represent a regulatory challenge, says expert
Regulatory affairs is still a major area of difficulty for companies that use CDMOs, according to analysis by Lachman Consultants.
Documentation and application preparation are the biggest challenges according to the group, which said differences between contractors’ systems are the core issue.
“Each CMO has their own format and systems for meeting GMP documentation requirements, which includes their own unique SOPs, work procedures, test methods, specifications and batch records. What this means for a regulatory department is that, for every new CMO, they need re-educate themselves.”
The European Commission has revised draft rules on sterile drug manufacturing as a result of industry feedback.
The Commission announced changes to the draft rules last week, explaining it had received input from more than 140 companies.
European rules governing the production of sterile drugs have not been revised significantly since 1971. The Commission, which started the review in 2017, said industry feedback prompted it to revise the proposed changes.
It has added paragraphs on the risks involved in material transfer, equipment and components in cleanrooms on the basis that such activities are a major source of potential contamination.
The commission also changed the section of heat sterilisation. Specifically it has removed a line stating chemical and biological indicators of heat sterilisation can be used in conjunction with physical measurements.
The EC is seeking feedback on the revised draft document before May 20.
Also in the news
Sanofi has said it will start an API manufacturing company. According to STAT the plan is to prevent future shortages.
The Washington Post reports that the coronavirus outbreak has increased demand for protective masks, which has resulted in shortages.
Some developments of note in the contract manufacturing space:
Pharmaceutics International, Inc has expanded its aseptic filling capacity and capabilities with the addition of a robotic filling line.
The US FDA has approved an application for a generic version of generic albuterol sulfate inhalation aerosol being developed by Perrigo and partner Catalent Pharma Solutions.
Altasciences has acquired Alliance Contract Pharma, a contracting firm that provides API manufacturing and analytical services.
Wuxi Biologics and Vir Biotechnology have partnered to to make human monoclonal antibodies for COVID-19, the disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Immunos Therapeutics has contacted ProBioGen to make biologics using its DirectedLuck Transposase technology.