In this week’s news, US settles on near-infrared analytics for drugs; WHO revises GMP guidelines and more…

US FDA sets out NIR drug assessment guidelines

The US FDA has published guidelines to help small molecule focused pharmaceutical firms and CDMOs understand how to use near-infrared (NIR)-based analyses in evaluating drug attributes.

The final guidance document – available here – explains how to assess finished drugs and starting materials using light energy just below the visible spectrum.

According to the agency NIR methods can be used to evaluate the “identity, strength, quality, purity, and potency of drug substances and drug products.”

EMA Oks Lonza and Moderna to scale up vax production at US plants

The EMA has given Lonza and Moderna the go ahead to scale up production of the API for Spikevax, the latter’s COVID-19 vaccine, at sites in the US.

The Amsterdam regulator announced the decision last week, explaining the sites in Norwood, Massachusetts and Lonza Biologics, Inc. in Portsmouth, New Hampshire “are capable of consistently manufacturing high-quality active substance.”

The EMA predicted that in the third quarter of 2021, the US supply chain will provide 40 million doses of vaccine for the European market.

WHO revises GMP regs with COVID-19 in mind

The WHO has rejigged its GMP guidelines for investigational products and R&D labs citing the COVID-19 pandemic.

The Geneva organisation issued the new guidelines – here and here – last week, explaining the have been revised to support regulators tasked with facility inspections.

Many of the revisions focus on staff. The GMP document, for example, includes the recommendation that “a responsible person should be designated for the release of batches.”

The document also specifies that “appropriate protective garments should be worn, based on operations and risk”.

Also in the news

The New York Times looked at the ongoing investigation of key US vaccine and biodefense CDMO Emergent Biosolutions. The firm was involved with the production of COVID-19 vaccines developed by J&J and AstraZeneca.

The paper also covered Novavax’s efforts to address concerns about production of its COVID-19 vaccine.

Drug companies and CDMOs in South Korea are likely to play a greater role in the production of COVID-19 vaccines according to Reuters, which reported that the country has pledge $2bn to expand manufacturing capacity by 2025.

Science provided details of potential COVID-19 therapies being examined in a new study.

The US Government is expected to make a decision on whether citizens need a COVID-19 booster vaccine shot according to a report by the Wall Street Journal.

CDMO trends

Some developments of note in the contracting sector:

DisperSol Technologies has hired Catalent as manufacturing partner for its cancer and rare disease drug candidates. The collaboration will see the CDMO install a commercial-scale KinetiSol technology manufacturing line at its Somerset, New Jersey facility.

Metrics Contract Services has expanded its oral solid dose commercial facility in Greenville, North Carolina, adding production space and new equipment.

Grand River Aseptic Manufacturing has opened a finishing and warehousing centre at its site in Michigan.

WuXi STA has completed the acquisition of a drug product manufacturing facility in Couvet, Switzerland from Bristol Myers Squibb.

Curia, formerly AMRI, has bought Integrity Bio, a privately held formulation and fill-finish organization headquartered in Camarillo, California.