Pharmaceutical Technology Editors

BioNTech announced on May 10, 2021 that it plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new messenger RNA (mRNA) manufacturing facility in Singapore.

The fully integrated mRNA manufacturing facility will accommodate BioNTech’s pipeline of mRNA-based product candidates and capabilities for rapid response production for southeast Asia’s potential pandemic threats, BioNTech said in a company press release. The new facility, which is set to be operational by 2023, will feature mRNA production capabilities for drug substance, drug product, and fill/finish, and will supply an estimated annual capacity of several hundred million doses of mRNA-based vaccines.

“Having multiple nodes in our production network is an important strategic step in building out our global footprint and capabilities. With this planned mRNA production facility, we will increase our overall network capacity and expand our ability to manufacture and deliver our mRNA vaccines and therapies to people around the world,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “Singapore provides an excellent business climate, growing biotechnology industry, and rich talent base. We would like to thank Singapore’s Economic Development Board who has been very supportive throughout our planning process and we look forward to contributing our technology and expertise to the development of the biotechnology industry in Singapore and this region.”

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BioNTech plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new mRNA manufacturing facility in Singapore. 

BioNTech to Establish Regional Headquarters and mRNA Manufacturing Facility in Singapore

Pfizer and BioNTech announced on May 7, 2021 that they have initiated a rolling submission of a biologics license application (BLA) to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

The companies initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the vaccine, Pfizer said in a company press release. The companies will continue to submit data on a rolling basis over the next few weeks, with a request for priority review from FDA.

Currently, the vaccine is available in the United States under an emergency use authorization granted by FDA on December 11, 2020.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US Government,” said Albert Bourla, chairman and CEO, Pfizer, in the press release. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

“Following the successful delivery of more than 170 million doses to the US population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” added Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “We are pleased to work with US regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for Their COVID-19 Vaccine

 on May 4, 2021 that it was voluntarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL. The recall was initiated because of incorrect labeling of a portion of each lot as the other product, which was identified as part of the investigation of a confirmed customer report.

Use of the impacted product, according to Hospira, may cause moderate to highly severe adverse events. Administration of 1% lidocaine instead of 0.5% bupivacaine may lead to the patient being underdosed, which may lead to inadequate pain management and failure of surgical anesthesia, according to the company. Administration of 0.5% bupivacaine instead of 1% lidocaine may lead to an overdose of bupivacaine, which could cause seizures, respiratory abnormalities, and heart abnormalities.

According to Hospira, 0.5% Bupivacaine Hydrochloride Injection, USP is used as local or regional anesthesia or analgesia for surgical procedures, diagnostic and therapeutic procedures, and obstetrical procedures. The other product, 1% Lidocaine HCl Injection, USP, is used as local or regional anesthesia by infiltration techniques, intravenous regional anesthesia by peripheral nerve block techniques, and by central neural techniques.

The impacted lots were distributed Dec. 29, 2020 to April 15, 2021 nationwide to wholesalers, distributors, retailers, and hospitals in the United States, Puerto Rico, and Guam. More information about the recalled lots can be found on FDA.gov. The company reports that no adverse events have been reported as of the date of the recall. Adverse events may be reported to FDA through the agency’s MedWatch program.

The company is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL because of incorrect labeling.

Hospira Recalls Anesthesia Medicines Due to Mislabeling

on May 4, 2021 that it was voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of a report of visible particulate found in a single vial. Sterile Water for Injection USP is used to dilute or dissolve drugs for intravenous, intramuscular, or subcutaneous injection. The impacted lot was distributed nationwide from October through December 2020.

According to the company, use of the impacted product could cause rare instances of anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. As of the date of the press release, the company has not received reports of adverse events associated with the recalled lot. Adverse events may be reported to FDA’s MedWatch Adverse Event Reporting program.

The company is recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of visible particulates.

Hospira Recalls Sterile Water for Injection 

on May 5, 2021 providing an overview of the agency’s inspectional activities during the COVID-19 pandemic and plans for inspection operations in the future. FDA postponed domestic and foreign inspections in March 2020 in response to the pandemic and began domestic inspections again in July 2020 using a rating system to prioritize those facilities where inspections were most needed. 

According to FDA, the agency conducted 821 mission-critical inspections from March 2020 through March 2021; 29 of those inspections were in foreign countries. A total of 777 prioritized domestic inspections were conducted since the agency resumed domestic inspections in July 2020. The report also outlines when the agency used alternative tools, such as remote livestreaming video, teleconferences, or screen sharing, when in-person inspections were not feasible.

FDA is planning a variety of scenarios for conducting inspections during the ongoing pandemic, with critical inspections being a primary focus and other higher-risk facilities being prioritized. Longer intervals between inspections will continue for less high-risk facilities, according to the agency, and postponed inspections will be prioritized based on risk and conducted over a longer period of time.

The agency is planning a multi-year modernization to transform its data enterprise platforms and cross-program interoperability infrastructure, which will include a review of next-generation assessment technologies. In addition, an agency-wide FDA Inspectional Affairs Council will be created to plan and coordinate inspectional activities.

“Like most organizations around the world, the FDA experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance, and compliance activities were significantly impacted,” said Acting FDA Commissioner Janet Woodcock, MD, in a

e. “The FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides the public with a transparent picture of both the successes and challenges we’ve faced in these areas over the past year, as well as our plan moving forward. We want to assure the American public that we have used a variety of tools to oversee the regulated industry and ensure that Americans continue to have access to safe food and high-quality FDA-regulated products.”

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

FDA on Inspections During and After Pandemic

On May 6, 2021, Lonza announced that it will be making significant investments to expand its mammalian drug substance manufacturing facilities in Visp, Switzerland, and Portsmouth, NH, in the United States. The company plans to spend CHF 850 million (US$936 million) in the expansions.

In Visp, the company plans to build a new large-scale mammalian drug substance manufacturing facility that will add six 20,000-L bioreactors to meet increasing market demand for biologics. This new high-throughput facility will have an area of approximately 27,500 m2 and will include perfusion capabilities while optimizing energy efficiency and water use. It will be designed to support high titer processes and will have the capability to accommodate the next generation of mammalian biologics, Lonza stated in a company press release.

The new Visp facility is expected to be completed in 2024 and will account for approximately CHF 650 million (US$715 million) of the total investment. The Visp expansion will complement the company’s existing large-scale global network at Portsmouth as well as its sites in Tuas, Singapore, and Porriño, Spain.

In Portsmouth, the company plans to build a next-generation facility to support late-phase clinical and commercial development and manufacturing. This facility will add capacity for up to eight 2000-L single-use bioreactors over an area of 3000 m2. The Portsmouth expansion will account for the remaining CHF 200 million (US$220 million) of the total investment. This expansion will help meet increasing market demand for small- to mid-scale mammalian-derived biologics and will support the implementation of high titer and high throughput platform processes, the company also stated in its press release. The new Portsmouth facility, expected to be completed in 2023, will be designed to support Phase III clinical and commercial small- to mid-volume products and will include state-of-the-art technologies in perfusion, purification, and automation. The facility will complement the existing single-use network at Lonza’s sites in Tuas and Visp as well as in Hayward, CA, and Slough, UK.

Lonza has already begun recruitment for both new facilities, which will create more than 300 new jobs in Visp and 250 new positions in Portsmouth.

“As we look at the biologics market, we see a combination of growth at pace coupled with continuing high customer demand. In recent months, the COVID-19 pandemic has placed the spotlight on supply chains and the critical role CDMOs [contract development and manufacturing organizations] play in ensuring an adequate supply of medicines. The expansion of both our large-scale and small-scale manufacturing capacity will ensure Lonza continues to deliver industry-leading contract manufacturing services that will support our customers’ needs in the medium and long term,” said Pierre-Alain Ruffieux, CEO of Lonza, in the company press release.

“At Lonza, we are focused on supporting our customers to achieve efficient, high-throughput production processes and flexible manufacturing solutions. Our customers’ needs range from the manufacture of small- to mid-volume products, such as innovative pharmaceuticals for rare diseases affecting smaller patient populations, to the large-scale commercial production of biologics. These expansions serve to strengthen our position as a critical partner in the development and manufacture of such medicines,” added Jean-Christophe Hyvert, president, Biologics and Cell & Gene, Lonza, in the press release.

Lonza plans to invest approximately CHF 850 million (US$936 million) to build new state-of-the-art mammalian manufacturing facilities at its Visp, Switzerland, and Portsmouth, NH, sites.