In this week’s news, FDA details excipient pilot and more…

US FDA shares details of excipient safety pilot

The US Food and Drug Administration’s new excipient pilot programme will require that drug firms and CDMOs provide the agency with detailed safety data.

Karen Davis Bruno, the FDA OND Associate Director of Pharmacology/Toxicology, shared details of the programme – here – explaining it is important that the industry carefully examines new excipients for potential toxicity.

“Excipients can play an important role in helping patients tolerate medications or transporting the drug within the body, excipients can also carry risks” Bruno said, citing the ability to provoke an allergic reaction as an example.

To address this the programme will give drug firms and CDMOs a pathway to evaluate the safety of excipients in context of how they are being used in formulation.

USP aims to make post approval analytical changes easier

USP has set out a “life-cycle approach” to analytical method development to make it easier for drug firms and CDMOs to revise analytical methods after product approval.

The method – detailed in a new draft chapter made publicly available this week –   “is to more fully address the entire [analytical] procedure life-cycle and define concepts that may be useful” according to the USP.

This approach is consistent with the concept of quality by design (QbD) as described in International Council for Harmonisation (ICH) Q8-R2, Q9, Q10, and Q11.

Also in the news

Politco looked at growing tensions between the US Government and Moderna about production of the latter’s SARS-CoV-2 vaccine.

The EU has called on the drug industry and CDMOs to help establish a network of “ever warm” vaccine manufacturing facilities that can be used during future pandemics.

The Pink Sheet reported that regulators in EU member states have extended the validity of CDMO and drug firm GMP/GDP certifications in light of the ongoing pandemic.

Sandoz has taken charge of GSK’s cephalosporin antibiotic API manufacturing and supply business according to a report by PM Live.

Reuters looked at the US’ decision to allow arriving air travellers to useCOVID-19 vaccines that have been cleared by the WHO.

CDMO trends

Some developments of note in the contracting sector:

Cambrex will expand its manufacturing centre in High Point, North Carolina. The CDMO said it will invest $30M to add capacity to meet growing demand for small molecule development and manufacturing services.

Catalent has opened a clinical supply facility in the Shiga prefecture of Japan citing increased demand for primary packaging and related services.

BioCina says Hospira has completed the hand-over of its biologics manufacturing facility in Adelaide, Australia.

Boehringer Ingelheim has opened an $800M plant in Vienna, Austria. The site houses 185,000 L bioreactor capacity and will support its CDMO business. Read more at Bioprocess Insider.

Humedix has partnered with immuno oncology and antibody development firm KIneta to strengthen its CMO business and secure new drugs for future growth.