Pharmaceutical Technology Editors

Catalent announced on May 6, 2021 that it has acquired therapy development company Promethera Biosciences’ cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its 32,400 ft2 facility in Gosselies, Belgium.

Under the terms of the agreement, the new facility will provide space for Catalent’s commercial-scale plasmid DNA (pDNA) manufacturing and service offering, Catalent said in a company press release. The facility also features an existing cleanroom infrastructure, process development and quality control laboratories, and warehouse space.

“Plasmid DNA manufacturing is a critical component to many biological therapeutics, including viral vectors, mRNA (messenger RNA), and cellular therapies. This investment allows Catalent to support these programs from development through to CGMP [current good manufacturing practice] commercial production, offering the full horizontal supply chain,” said Manja Boerman, PhD, president, Catalent Cell & Gene Therapy, in the press release. “The Center of Excellence we have established in Belgium brings critical experience and expertise together on one campus, allowing for key synergies to best support our customers.”

“Promethera is thrilled to divest its HCTS facility to Catalent, alongside its new strategy to concentrate activities on its core expertise and breakthrough approach using advanced therapies to restore liver health in patients with life-threatening liver diseases,” added Professor Etienne Sokal, president of Promethera, in the press release.

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Catalent has acquired Promethera Biosciences’ cell therapy manufacturing subsidiary, which includes a 32,400 ft2 facility in Gosselies, Belgium.

Catalent to Acquire New Facility in Belgium for Commercial-Scale Plasmid DNA Manufacturing

The International Society for Pharmaceutical Engineering (ISPE) announced on May 6, 2021 that it will virtually host the 2021 ISPE Global Pharmaceutical Regulatory Summit on June 16, 2021 and the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference from June 17–18, 2021.

According to a company press release, the virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.

“The global pandemic has impacted all operations, no matter the size or manufacturing capabilities. As companies in the Asia Pacific region and around the world adapt to changing regulatory processes, contend with remote and limited inspections, and manage increasing demands on CMOs, effective quality risk assessment and risk mitigation have become exponentially more significant,” said Frances Zipp, president and CEO, Lachman Consultant Services, and conference co-chair, in the press release. “These events require a visionary approach in assessing the challenges facing pharmaceutical operations on a global basis, specifically for those that are critical to the supply of essential medicines, such as in the Asia Pacific region, amid unpredictable times.”

“Collaboration and communication are a crucial element in mitigating the impact of COVID-19 on pharmaceutical operations,” added Carmelo Rosa, director, Division of Drug Quality I, FDA/CDER/OC/OMQ, and conference co-chair in the press release. “During both events, attendees will have the chance to ask questions to industry experts and regulators and learn about the strategies and insights other companies are using to make their operations more agile, compliant, and resilient to disruption.”

David Churchward, deputy unit manager, Inspectorate Strategy & Innovation, Medicines and Healthcare products Regulatory Agency (MHRA)

Jesusa Joyce N. Cirunay, director IV, Center for Drug Regulation and Research, Food and Drug Administration Philippines

Brendan Cuddy, lead scientific officer, European Medicines Agency (EMA)

Cormac Dalton, vice-president, Quality Assurance (European Union), AbbVie

Benjamin Noyen, assistant secretary, Health Products Regulation Group, Therapeutic Goods (TGA)

Ranjana Pathak, PhD, global head of Quality, Cipla

Conference speakers and panelists include:

Jila Breeze, executive vice-president, global head, Quality & Compliance, SUN Pharmaceuticals Inc.

David Churchward, deputy unit manager, Inspectorate Strategy and Innovation, MHRA

V. Ray Gaines, branch chief, Global Compliance Branch III, CDER/FDA

R. Derek Glover, head of Global Quality, Viatris

Joey Gouws, PhD, team lead, Inspection Services, Prequalification Team

Narendira Kumar, Site Quality head, Dr. Reddy’s Laboratories

Brooke Higgins, senior policy advisor, Office of Manufacturing Quality, CDER/FDA

Kevin O’Donnell, PhD, market compliance manager, Health Products Regulatory Authority (HPRA)

Aditi Thakur, acting quality assessment lead, FDA/CDER

ISPE’s virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency. 

ISPE to Host Two Virtual Quality Risk Management Events

AstraZeneca announced on April 30, 2021 that its sodium-glucose cotransporter 2 (SGLT2) inhibitor, Farxiga (dapagliflozin), was approved by FDA for use in the United States to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of progression.

The approval was based in positive results from the DAPA-CKD Phase III trial, which showed that Farxiga, in combination with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, risk of CV, and renal death by 39%, AstraZeneca said in a company press release. The drug also underwent a DECLARE-TIMI 58 Phase III trial which demonstrated that Farxiga is also likely to be effective in patients with less advanced CKD.

“Today’s approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca. “We’ve shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US.”

FDA has approved AstraZeneca’s Farxiga (dapagliflozin) for treating chronic kidney disease in the United States.

FDA Approves AstraZeneca’s Kidney Disease Treatment

Moderna announced on May 4, 2021 that it is doubling the space of its Moderna Technology Center in Norwood, MA, to transform it from a production and lab space into an industrial technology center.

The expansion will include increasing the facility’s production and lab space from 30,000 ft2 to 650,000 ft2 through renovations and the acquisition of an additional 240,000-ft2 space located on the same campus, Moderna said in a company press release. The expansion will also include a 50% increase in production of Moderna’s COVID-19 vaccine and an increase in the company’s technical development capacity and preclinical production capabilities.

“Our manufacturing facility has been core to our long-term strategy and has enabled us to provide the scale and flexibility to support the development of our mRNA [messenger RNA] medicines and vaccines, including our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, in the press release. “We believe that this investment and expansion at our technology center will allow us to continue to optimize our mRNA products as we explore new pharmaceutical delivery forms, such as prefilled syringes and lyophilized products. As we grow, we are committed to minimizing our environmental footprint.”

Moderna will double the space at its Moderna Technology Center in Norwood, MA, to transform it from a production and lab space into an industrial technology center. 

Moderna to Expand its Massachusetts Manufacturing Technology Center

Cellares Corporation, a US-based life sciences technology company, announced on May 5, 2021 that it has raised $82 million in a Series B round to accelerate the development of its Cell Shuttle, a factory-in-a-box that allows for the automation of the process of creating highly individualized cell therapies, including chimeric antigen receptor (CAR)-T therapies.

According to a company press release, the Cell Shuttle is equipped with hardware, software, robotics, and consumables, making it capable of producing 10 patient doses simultaneously, while allowing for easily transferable pre-clinical development and efficient commercial scalability.

“There are more than 450,000 patients today who could potentially benefit from CAR-T cell therapies, a number expected to grow into the millions in a few years’ time. Less than 1% of these patients are able to get access to these therapies, due to a lack of scalable cell manufacturing technologies,” said Fabian Gerlinghaus, co-founder and CEO of Cellares, in the press release.

Cellares has raised $82 million to accelerate the development of its Cell Shuttle, a factory-in-a-box that allows for the automation of the process of creating highly individualized cell therapies.

Cellares Raises Funding to Accelerate Cell Therapy Manufacturing Automation Device

Moderna announced on May 3, 2021 that it has entered into an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of Moderna’s COVID-19 vaccine to low-income countries.

The agreement is part of a partnership between the COVAX Facility, a global initiative co-led by Gavi, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization. Under the terms, Moderna will supply the vaccine to the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries, Moderna said in a company press release. Gavi will also maintain the option to obtain 466 million additional doses in 2022.

“I am grateful to our Gavi and COVAX partners for their tireless work and to the entire Moderna team for their collaboration to reach this agreement. This is an important milestone as we work to ensure that people around the world have access to our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, in the press release. “We recognize that many countries have limited resources to access COVID-19 vaccines. We support COVAX’s mission to ensure broad, affordable and equitable access to COVID-19 vaccines, and we remain committed to doing everything that we can to ending this ongoing pandemic with our mRNA [messenger RNA] COVID-19 vaccine.”

“We are very pleased to sign this new agreement with Moderna, giving COVAX Facility participants access to yet another highly efficacious vaccine,” added Seth Berkley, CEO of Gavi, in the press release. “Expanding and having a diverse portfolio has always been a core goal for COVAX, and to remain adaptable in the face of this continually evolving pandemic—including the rising threat posed by new variants. This agreement is a further step in that direction.”

Moderna has entered into an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine to the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries. 