Pharmaceutical Technology Editors

FDA issued an emergency use authorization to ACON Laboratories Flowflex COVID-19 Home Test, an over the counter COVID-19 antigen test, on Oct. 4th, 2021. According to a press release from the organization, this was done to increase rapid testing accessibility for the general public in the United States.

According to an FDA press release, the authorization of the new antigen test will double rapid at-home testing capacity in the US over the next several weeks. ACON plans to produce more than 100 million tests per month by the end of the year and will begin making 200 million per month by February 2022.

FDA has authorized more than 400 COVID-19 tests and sample collection devices, but most antigen tests for at-home use are authorized for serial testing or testing the same individual more than once within a few days. As a result of data provided concerning asymptomatic individuals, the ACON test does not require serial testing.

“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,” FDA said in the press release. “We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans.”

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FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

FDA Grants Emergency Use Authorization for OTC COVID-19 Test

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced on Oct. 5th, 2021, that they would invest $3 million in six new biopharmaceutical manufacturing products. Each project will measure glycans through liquid chromatography–mass spectrometry (LC-MS) in some way.

The institutions receiving funding include:

According to a press release from NIIMBL, each of these projects is specifically geared toward supporting NIIMBL’s Project Call 5.1. The goal of Project Call 5.1 is to perform small group studies that will help determine the variability associated with key product attributes for therapeutic proteins while investing in state-of-the-art analytical instrumentation infrastructure that will be available across the NIIMBL community.

“This project call is a complement to our recent and future project calls and helps to build infrastructure for NIIMBL efforts in one of the important product characterization technologies for our community,” said Chris Roberts, associate institute director at NIIMBL, in the press release. “It was implemented in a similar way to recent rapid project calls from NIIMBL that are in parallel with our multi-stage project calls such as PC5.2 that is expected to be announced later this year.”

Detailed breakdowns of each study can be found at the 

The $3 million investment will go towards various projects investigating key product attributes for therapeutic proteins.

NIIMBL Invests $3 Million in Six Biopharmaceutical Manufacturing Products

on Oct. 7, 2021 that its Committee for Medicinal Products for Human Use (CHMP) has approved a manufacturing site operated by Merck Sharp & Dohme for the production of Janssen’s COVID-19 vaccine. The site is located in West Point, Pa. in the United States and will manufacture finished product to support supply to the European Union.

Because CHMP’s recommendation does not require a decision from the European Commission, the site can become operational immediately.

“EMA is in continuous dialogue with all marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines. The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites, or increase the capacity of existing sites for the manufacture of high-quality COVID-19 vaccines,” the agency stated in a press release.

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine. 

EMA Approves Manufacturing Site for Janssen COVID-19 Vaccine

 on October 4, 2021 that its Committee for Medicinal Products for Human Use (CHMP) has decided that individuals with severely weakened immune systems may receive an additional dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna), at least 28 days after they receive the second dose of the vaccine. EMA stated in a press release that studies show an extra dose of the vaccine increased the organ transplant patients’ ability to produce antibodies against the COVID-19 virus.

“Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients. EMA will continue monitoring any data that emerges on its effectiveness,” the agency stated in the press release.

For people with normal immune systems, CHMP concluded that booster doses may be considered six months after a person’s second dose for people aged 18 and older. Data for Comirnaty showed a rise in antibody levels after the administration of booster shot six months after the second dose in people 18–55 years old, according to EMA. CHMP is continuing to evaluate data regarding booster shots of Spikevax.

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

EMA Recommends Boosters of Pfizer and Moderna COVID-19 Vaccines for Some Individuals

on October 4, 2021 that it has received an application for marketing authorization for Regkirona (regdanvimab) from Celltrion Healthcare Hungary Kft. Regkirona (regdanvimab) is a monoclonal antibody (mAb) for the treatment of COVID-19 patients who are at increased risk of developing severe COVID-19 but do not require supplemental oxygen therapy.

The agency plans to assess the risks and benefits of the mAb on a reduced timeline and, based on the robustness of the data, may have an opinion in two months because some data were already reviewed during a rolling review. A preliminary assessment of the company’s risk management plan has already been completed by EMA’s safety committee. The agency’s committee for medicines for children also issued its opinion on the company’s pediatric investigation plan.

“Should the additional data now submitted with the marketing authorisation application be sufficient for CHMP to conclude that the benefits of Regkirona outweigh its risks for the treatment of COVID 19, EMA will liaise closely with the European Commission to fast track the decision granting marketing authorisation in all EU and EEA Member States,” the agency stated in a press release.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

Application for COVID-19 Treatment Submitted to EMA 

MilliporeSigma announced the launch of the Viscosity Reduction Excipient Platform for protein-based therapeutics on Oct. 4, 2021. The platform is designed to reduce viscosity while maintaining protein stability, which should help therapeutic candidates overcome formulation challenges associated with highly concentrated protein solutions.

According to a company press release, subcutaneous administration is the preferred route for protein-based therapeutics, such as monoclonal antibodies or plasma derived proteins, because it improves patient compliance. However, because these formulations require highly concentrated protein formulations to meet intended dosing regimens, they tend to exhibit elevated viscosities that present challenges in the manufacturing and final formulation processes.

The program is based on the combination of two new excipients, an amino acid and anionic component. According to the press release, this combination allows for viscosity reduction beyond what is possible with a single excipient, allowing for an improved viscosity/stability balance that will help therapeutic candidates overcome these challenges.

Every excipient candidate in the platform has previously been used individually in approved drug products for humans through parenteral administration in functions such as active ingredients in parenteral nutrition or pH adjusters. They will all be made available in the company’s Emprove Expert portfolio, which is intended to accommodate current and upcoming regulatory requirements.

New excipients for protein-based drug products reduce viscosity while maintaining protein stability.