Pharmaceutical Technology Editors

Many COVID-19 treatments and vaccines use glass vials and stoppers as their container closure system (CCS), and supply of these components may become constrained, according to FDA. Because of this, manufacturers may need to update approved applications to make changes to CCS components. FDA, therefore, 

on March 4, 2021 providing recommendations for reporting and implementing changes to COVID-19 CCS components that consist of glass vials and stoppers for parenteral sterile drug products and biologics.

“In response to this public health emergency, FDA will consider risk-based approaches to facilitate implementation of chemistry, manufacturing, and controls (CMC) changes to a CCS in an effort to mitigate the disruptive effect of the COVID-19 pandemic. These measures may include, but may not be limited to, recommendations for adjustments to submission content and reduction in reporting categories for CMC changes,” the guidance states.

The guidance discusses regulatory approaches to CMC changes and common changes to glass vials and stoppers. The guidance also discusses risk-based tools for implementing CCS changes and comparability protocols.

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The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.

FDA Publishes Guidance on Changes to COVID-19 Container Closure Systems

Merck (known as MSD outside the United States and Canada) will receive up to $268 million from the Biomedical Advanced Research and Development Authority (BARDA), US Department of Health and Human Services, to adapt and make available some of the company’s manufacturing facilities for the production of COVID-19 vaccines and medicines.

On March 2, 2021, the company announced multiple agreements with BARDA and Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), to support the manufacturing and supply of J&J’s single-dose COVID-19 vaccine. Merck will produce drug substance, formulate, and fill vials of the vaccine at US facilities.

Biden Administration invoked the Defense Production Act

 to equip the Merck facilities for this “historic manufacturing partnership” of two pharmaceutical giants, a White House spokesperson said.

“We are steadfast in our commitment to contribute to the global response to the pandemic as part of the remarkable efforts of the entire medical and scientific community,” said Mike Nally, executive vice president, Human Health at Merck, in the press statement. “This funding from BARDA will allow us to accelerate our efforts to scale up our manufacturing capacity to enable timely delivery of much needed medicines and vaccines for the pandemic.”

“At Merck, we have a rich legacy in vaccine manufacturing and look forward to combining our expertise with Johnson & Johnson to help increase supply and expand access to authorized SARS-CoV-2/COVID-19 vaccines,” said Sanat Chattopadhyay, executive vice president and president, Merck Manufacturing Division, in the statement.

anssen COVID-19 vaccine received Emergency Use Authorization from FDA on Feb. 27, 2021 

and initial supplies of vaccines shipped on March 1, 2021.

Merck discontinued development of two COVID-19 vaccine candidates

, when studies showed the immune response was inferior to levels following natural infection. The company announced plans to focus research and production capabilities on two COVID-19 therapeutic candidates.

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.

Merck to Manufacture J&J Vaccine

AstraZeneca has announced, in a March 2, 2021 press release, that the mass rollout of its COVID-19 vaccine has begun via the COVAX initiative. These first steps by the company in the distribution of the vaccine to low- and middle-income countries will fulfill its efforts to provide broad and equitable access.

So far, shipments of the vaccine have been dispatched to Ghana and Cote D’Ivoire with more expected to begin arriving in the Philippines, Indonesia, Fiji, Mongolia, and Moldova shortly. Vaccine shipment allocations have been made according to the COVAX Allocation Framework, which determines volume per participating country based on several factors, such as readiness and national vaccination plans.

“These first steps towards fulfilling our broad, equitable, and no-profit emergency response to the pandemic mean millions of people, irrespective of their country’s income level, will soon be protected against this deadly virus,” said Pascal Soriot, CEO, AstraZeneca, in the press release. “This is a moment of great pride for us at AstraZeneca and I am extremely grateful to our partners including Gavi, CEPI, and Oxford University for their hard work and dedication in order to make this humanitarian ideal a reality for many millions of people around the world.”

“Global, equitable access to COVID-19 vaccines is only possible when the public and private sectors work together,” added Seth Berkley, CEO, Gavi, in the press release. “When we launched the Gavi COVAX Advance Market Commitment in June 2020, our first Agreement was with AstraZeneca. Nine months later, the first doses are already being delivered to those that need them most. This is the beginning of COVAX’s effort to end the acute phase of the pandemic, not the end, but we can all take strength from this moment and I thank AstraZeneca and the University of Oxford for their support and partnership at every step of our journey.”

AstraZeneca has announced that the mass rollout of its COVID-19 vaccine has begun via the COVAX initiative. 

AstraZeneca Progresses Rollout of COVID-19 Vaccine to Low- and Middle-Income Countries

Retinal therapeutics development company, Oxular, has announced in a March 1, 2021 press release that it has raised US $37 million in a financing round led by specialist life sciences investor, Forbion.

The monies raised will be used to fund Phase II clinical studies evaluating the company’s 12-month treatment for diabetic macular edema (DME), OXU-001. The studies are expected to start later in 2021. Additionally, funds will be allocated to progressing the company’s early-product pipeline.

“We are pleased to add such a renowned investor as Forbion to our already supportive investor base, including IP Group, NeoMed, and V-Bio Ventures,” said Thomas Cavanagh, CEO of Oxular, in the press release. “These are experienced healthcare investors who see the potential of Oxular’s disruptive technology and innovative treatment approach—which is tissue-specific delivery of potent drug products that safely provide up to 12-months’ treatment durability for retinal disease.”

“Oxular has built an exceptional platform that has the potential to unlock the full therapeutic potential of potent molecules and significantly improve patients’ lives by providing safe, efficacious and convenient treatment options,” added Dr. Dmitrij Hristodorov, principal at Forbion and non-executive director at Oxular, in the press release. “We are pleased to lead this financing round and look forward to seeing the progress that the team at Oxular makes over the coming years, in both its clinical and preclinical programs.”

Oxular has raised US $37 million in a financing round led by specialist life sciences investor, Forbion.

Oxular Completes Financing Round Worth $37 million

Growth-oriented private equity firm, Arcline Investment Management, has acquired sterile and contained pharmaceutical product transfer specialist, ChargePoint Technology, strengthening global presence.

According to a March 1, 2021 press release, the deal will involve the incorporation of ChargePoint Technology into Arcline’s broader specialty process technologies platform offering to support global customers. Through the acquisition, ChargePoint Technology will be able to further progress its development pipeline in enhanced sterile and contained process solutions. Additionally, it is expected that Arcline will be making several other acquisitions to support ChargePoint’s process technology platform and create a tailored biopharma processing offering.

“Partnering with Arcline is an incredible opportunity for us to further strengthen our commitment to delivering high-quality world class process solutions for our customers,” said Chris Eccles, CEO at ChargePoint Technology, in the press release. “Arcline share our energy, focus, and passion, a powerful synergy, which will further catalyze the innovation of our products and improve the support we offer customers across the globe. We look forward to working with the team at Arcline to build the process solution platforms of the future.”

Arcline Investment Management has acquired ChargePoint Technology, strengthening its global presence.

Arcline Investment Management Acquires ChargePoint Technology

A recent survey by SwedenBIO—a national non-profit association—has demonstrated a major upswing in the Swedish life science industry. The results of the survey were revealed in a March 2, 2021 press release.

The survey targeted pharmaceutical development companies with operations in Sweden and found that a vast majority (80%) of those surveyed are planning on expanding with new hires in the coming year. Additionally, when comparing with survey results from a year ago, it was revealed that there was increased confidence in projecting future growth with 62% of those surveyed expressing a more positive view of projections now.

“The positive outcome of our follow-up survey is very encouraging for the future,” said Helena Strigård, director general, SwedenBIO, in the press release. “The results also confirm our belief that involvement with other global life science hot spots opens more opportunities for collaboration and drives growth. We have, in fact had several fruitful interactions with similar organizations in regions internationally, including California. Furthermore, the fact that overall, the disturbances due to COVID have been limited and that numerous Swedish companies have re-focused their development towards COVID-related tests or treatments, underscores the strength of the industry as a whole and how creative and dedicated our life science industry experts are.”

Further information about the survey and a special investment conference being held in April 2021 can be found on SwedenBIO’s website.

A recent survey by SwedenBIO has demonstrated a major upswing in the Swedish life science industry. 