Pharmaceutical Technology Editors

Merck has expanded its vaccines manufacturing facility located in Elkton, Va. to increase its supply of HPV vaccines, as well as enable broader equitable access to the vaccine. The facility is 120,000 square feet and has added 150 new jobs.

In 2019, Merck committed more than $1 billion to expanding its production capacity at existing manufacturing facilities and building new facilities to address the global demand for HPV vaccines. The company successfully doubled its HPV vaccine supply from 2017–2020 and anticipates doubling it again between 2020–2023.

“As we continue to increase production of our HPV vaccines, we are prioritizing access in countries with a high burden of disease, including countries eligible for support from Gavi and UNICEF,” said Dr. Priya Agrawal, global lead for HPV Vaccines at Merck, in a press release. “Through our long-term agreement with UNICEF, we plan to provide 91.5 million doses of our HPV vaccines for use in Gavi-supported countries from 2021–2025, and we have offered additional doses beyond that agreement as needed to help meet growing demand.”

“Increasing supply of our HPV vaccines is a top priority, and over the last several years we have steadily increased our manufacturing capacity in response to growing global demand,” said Jacks Lee, senior vice president, Merck Manufacturing, in a press release. “Despite the pandemic, our teams have completed the building infrastructure expansion at our Elkton site ahead of schedule and we are excited to reach this important milestone.”

Articles

Merck has expanded its manufacturing facility in Elkton, Va. to further increase its HPV vaccine supply.

Merck Expands Manufacturing Facility in Elkton, Virginia 

Pfizer and BioNTech announced on March 29, 2022 that FDA has expanded the Emergency Use Authorization (EUA) of their COVID-19 vaccine to include a second booster dose in adults aged 50 years and older. The second booster dose would apply to those who have already received a first booster dose of any authorized COVID-19 vaccine.

Additionally, FDA has authorized a second booster dose for individuals aged 12 years and older who are immunocompromised and have already received a first booster dose of any authorized COVID-19 vaccine. The second booster should be administered at least four months after the first booster dose.

The Pfizer-BioNTech COVID-19 vaccine was previously authorized as a single booster dose in individuals aged 12 and older after the completion of the companies’ primary vaccination series. The authorization of the second booster dose aims to further protect the most vulnerable individuals and extend and strengthen the levels of protection against COVID-19 in anticipation for potential future waves.

The vaccine is based on BioNTech’s proprietary messenger RNA technology, and BioNTech is the Marketing Authorization Holder in the United States, the European Union, United Kingdom, and Canada. BioNTech and Pfizer are jointly the holders of EUAs or equivalents in the US and other countries.

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

Pfizer and BioNTech Receive Expanded US Emergency Use Authorization for an Additional COVID-19 Vaccine Booster 

ten23 health, a global contract development and manufacturing organization (CDMO), announced on March 28, 2022 that it is expanding swissfillon’s manufacturing site in Visp, Switzerland. The site was acquired in October 2021 from swissfillon and will be expanded into an adjacent building with an additional 1000 square meters of cleanroom space.

The expansion will also increase the company’s cold storage and visual inspections capacity and add 1000 square meters of cleanroom space for additional services such as device assembly and secondary packaging by the end of 2022. This expansion is in addition to its 4000 square meters of lab and office space for its operations in Basel, Switzerland, which was launched in September 2021.

“Only five months ago, swissfillon joined ten23 health. This first expansion of the footprint in Visp is a strong commitment to our location in the Valais as well as Switzerland and a testimonial of the competent and experienced team at Visp,” commented Prof. Dr. Hanns-Christian Mahler, CEO of ten23 health, in a press release. “Furthermore, it is an important step in our long-term strategy to expand out manufacturing capacity for complex sterile dosage forms for our customers and their patients.”

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms. 

ten23 health Expands its Sterile Drug Product Manufacturing Site at Visp, Switzerland

Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), announced on April 5, 2022 a £1 million expansion project at the company’s bioconjugation and antibody-drug conjugates (ADCs) facility in Deeside, UK.

The project will expand the laboratory space from 275 to 419 square meters and reconfigure the facility’s layout to better support the development and expansion of areas for future additional services. The investment is part of a broader goal of the growth of the company’s ADC capabilities since the acquisition of the UK site in April 2021. Other goals include expanding the facilities scientific and analytical teams, establishing current good manufacturing practice (CGMP) bioconjugation/ADC manufacturing capabilities, and recruiting up to five additional scientists at the facility.

The site’s process development laboratory has expanded with the addition of a new mass spectrometer, which will serve the company’s ADC business as well as support the company’s customer analytical services of ADC and small-molecule development. The instrument is able to safely handle and analyze cytotoxic and highly potent materials due to its location in a controlled environment with temperature controls, airlocks, and HEPA filters.

“Having the capabilities to develop ADC bioconjugation methods and scale up through to GMP manufacture in the same location has been one of Sterling’s major priorities since the acquisition of the Deeside facility, enabling projects to progress through development phases without needing relocation or tech transfer,” said Stewart Mitchell, Sterling’s Deeside site head, in a press release. “We are currently integrating the site’s quality management systems in line with our global practices and are now commissioning the QC and manufacturing facilities in readiness for GMP certification, which we anticipate will be in place by late 2022.”

Sterling Pharma Solutions has unveiled a £1 million expansion project to increase its capabilities and laboratories capacity at its Deeside, UK site.

Sterling Pharma Solutions Expands Capabilities and Laboratory Capacity

A grant of £15.9 million (approximately US$20.8 million) has been awarded to chemical producer Croda to increase the United Kingdom’s manufacturing capacity of specialty lipids, an essential ingredient in messenger RNA (mRNA) vaccines, the company announced on March 31, 2022. The grant will significantly increase Croda’s production capacity at its facility in Leek, Staffordshire.

The investment will also allow for the ability to increase both range and volume of lipid production in the UK, specifically the mRNA lipid used in numerous COVID-19 vaccines. The Leek facility will also see an increase in jobs due to the investment.

The increase in the production of mRNA lipids has the potential to transform vaccines in the future as well as further develop those existing currently. mRNA has been crucial to the production of many COVID-19 vaccines and will be able to aid in producing flu vaccines and develop new technologies such as gene therapies for cancer and heart disease.

“The development of mRNA technology has been one of the greatest scientific leaps forward since the start of the pandemic and the potential for its use in future therapies – potentially treating cancer and heart disease – is remarkable,” said Business Secretary Kwasi Kwartneg in a press release. “I am therefore extremely pleased to announce this support for Croda, a market leader in the manufacture of essential mRNA components, and the only manufacturer of lipids currently operating in the UK. Not only will this funding provide a significant boost to Britain’s life sciences industry, enabling the production of an extra 3 billion vaccine doses domestically, but it also represents an important investment into the West Midlands’ economy as we work to onshore manufacturing to the UK.”

UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients. 

UK Government Awards £15.9 million grant to Chemical Producer Croda

Research from the University of Michigan has demonstrated that twirling infrared light can be used to probe the structures of molecular crystals. The finding, reported in a March 21, 2022 announcement issued by the university, addresses one of the difficulties associated with drug development, which is determining if drugs and supplements with chiral structures are turning in the correct direction.

Drugs containing molecules with the wrong twist can cause unpleasant or dangerous side effects. According to the university’s announcement, this method uses terahertz radiation, a portion of the infrared part of the spectrum, to quickly recognize wrong twists and wrong chemical structures in packaged drugs.

Researchers hope that the technique can also be used to find harmful accumulations of twisted molecules in the body. This could help diagnose bladder stones, insulin fibrils, and amyloid aggregations such as the plaques that appear in Alzheimer’s disease, according to the university’s announcement.

“We foresee new roads ahead—for instance, using terahertz waves with tailored polarization to manipulate large molecular assemblies,” said André Farias de Moura, professor of chemistry at the Federal University of São Carlos, in the announcement. “It might replace microwaves in many synthesis applications in which the handedness of the molecules matters.”

The technique was developed by an international team consisting of researchers from Federal University, the Brazilian Biorenewables National Laboratory, the University of Notre Dame, and Michigan State University.

Research from the University of Michigan showed that Terahertz light can be used to probe both the structures of molecular crystals and their twists.