Pharmaceutical Technology Editors

Emerson announced the opening of a gas analysis solutions facility in Cumbernauld, Scotland on Aug. 29, 2022. The 62,000 ft² facility is designed to help companies reduce their environmental impact.

According to a company press release, the center has access to more than 10 different sensing technologies that can measure more than 60 different gas components. It will also engineer and manufacture Emerson’s Rosemount continuous gas analyzers and gas chromatographers, which are tools designed to improve monitoring emissions, plant safety, quality control, and operational efficiency.

“The mission of our new gas analysis solutions center is to support industrial manufacturers in achieving their decarbonization and environmental sustainability goals, including the deployment of low-carbon fuels and power sources, reducing emissions, and decreasing waste,” said Jon Stokes, group president of Emerson’s measurement solutions business, in the release. “It’s the latest addition to our investment in innovation that will help to achieve a more sustainable future.”

The facility has a gas extraction system, environmental chamber, and an external gas storage to facilitate gas analyzer testing, as well as application research and development. It includes a training space and offers various training options for customers, including in-person and web-based courses. It also has a dedicated area for performing factory acceptance testing and a customer collaboration space.

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Emerson’s new gas analysis solutions center, located in Cumbernauld, Scotland, intends to help plants meet sustainability goals.

Emerson Opens Gas Analysis Solutions Center in Scotland

Thermo Fisher announced the official opening of its new 300,000 ft² facility, located in Plainville, Mass., on Aug. 24, 2022. The new site is designed to support the development, testing, and manufacture of viral vectors.

In addition to its viral vector services, the new site includes translational sciences labs for early-stage development, plasmid DNA manufacturing, cell therapy manufacturing, and integrated commercial packaging and distribution services. Outside of bioproduction and analytical instrumentation technologies, the new site features sustainable construction design, flexible laboratory and production suites, adjacent warehousing, and office space, according to a company press release.

“Plainville is an impressive addition to our pharma services network as we continue to invest and innovate cell and gene therapy services, products and workflows,” said Marc N. Casper, chairman, president, and CEO, Thermo Fisher Scientific, in the release. “We are enabling our customers to speed their scientific discoveries in cell and gene therapy while also supporting their manufacturing needs, whether they are early in the development process or ready to transition to clinical or commercial scale.”

According to the release, the new site will add approximately 300 jobs to the local economy. It is Thermo Fisher Scientific’s sixth viral vector site in the United States and Europe.

Thermo Fisher Scientific’s new 300,000 ft² facility, located in Plainville, Mass., will specialize in manufacturing viral vectors.

Thermo Fisher Scientific Opens Viral Vector Manufacturing Site in Massachusetts

The National Institute of Health (NIH) announced on Aug. 25, 2022, that scientists funded in part by the NIH have successfully generated a mouse embryo model, or embryoid, that develops beyond the formation of the neural tube. Because the model closely mirrors natural mouse embryos 8.5 days after fertilization, this embryoid could potentially be used for research into factors affecting mammalian embryonic development and disease.

According to an agency press release, the researchers combined mouse embryonic stem cells (ESCs) with two types of mouse extraembryonic stem cells that yield the yolk sac and placenta. This enabled development of all brain regions, as opposed to models that just use ESCs. The structure was developed within a yolk sac that formed blood islands, structures designed to support the embryo and its circulatory system. In addition to the neural tubes, a gut tube and precursor cells for sperm formation developed.

The neural tube was flanked by somites, cells that lead to vertebrae, skeletal muscle, cartilage, and so on. The neural tube responded to a developmental challenge in a similar manner to natural mouse embryos. This evaluation was done by depriving the embryo of Pax6, a protein needed for brain and eye development; the resulting neural tubes appeared identical to those that develop in natural mouse embryos lacking the protein. According to the release, the researchers believe that this could be used to explore the genetic and epigenetic factors regulating development, as well as screen for the effects of various chemicals on mammalian embryo development.

This research is being led by Magdalena Zernicka-Goetz, of the California Institute of Technology and University of Cambridge. It is partially supported by Eunice Kennedy Shriver, of the NIH’s National Institute of Child Health and Human Development.

Scientists have developed a mouse model that could be a promising model system for research into factors affecting mammalian embryonic development and disease.

NIH-Funded Scientists Develop Mouse Embryo Model That Generates Neural Tubes

Novavax announced on Aug. 26, 2022 that the company’s COVID-19 vaccine, Nuvaxovid, was granted expanded conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency. This authorization allows for the use of the vaccine in adolescents aged 12 to 17.

According to a company press release, the authorization is based on data from the Phase III PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the United States. The trial reached its primary effectiveness endpoint and demonstrated 80% clinical effectiveness.

"As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in the UK," said Stanley C. Erck, president and CEO, Novavax, in the release. "We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates."

Following this announcement, Nuvaxovid is now approved for use in adolescents in the UK, US, the European Union, India, Australia, Japan, Thailand, and New Zealand. It is currently under review in several other markets.

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.

MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization 

Canvax, a European supplier of enzymes, recombinant proteins, and similar products, announced the release of a new inorganic pyrophosphate on Aug. 25, 2022. The new enzyme, isolated from E. coli, is a DNA replication enhancer with ≥ 95% purity and has an enhanced capacity for increasing RNA yield in 

The enzyme has been stable under temperatures below 80º and is free of endonucleases, exonucleases, and RNAses. According to a company press release, this makes it ideal for use in RNA IVT reactions because it can reduce the inhibitory effects of protein-protein interactions. The company also stated in the release that it is suitable for messenger RNA-based vaccine manufacturing, RNA labeling, and enhancement of DNA replication.

“We're glad to contribute with this new launch, significantly to supporting mRNA vaccines manufacturing, and we're pleased that the research community has embraced our pyrophosphatase and our RNA enzymes portfolio,” said Jesus C. Morales, business development manager, Canvax, in the release.

Canvax’s new inorganic pyrophosphate is designed for in-vitro transcription reactions.

Canvax Releases New Inorganic Pyrophosphate

The European Union officially released its revisions to its good manufacturing practice Annex 1 regulatory document on Aug. 25, 2022. These regulations, which pertain to manufacturing sterile drugs in the EU, are set to go into effect exactly one year after its publication, on Aug. 25, 2023.

According to the revised Annex 1: “The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommend that the current version of annex 1, on the manufacture of sterile medicinal products, is revised to reflect changes in regulatory and manufacturing environments. The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q10 guidelines” (1).

Originally published in 2008, Annex 1 was most recently revised in 2020. Following the most recent revisions, Annex 1 sits at 59 pages; and when it was originally published it had 16.

Annex 1: Manufacture of Sterile Medicinal Products

The European Union publishes long-awaited changes to Annex 1. 