Pharmaceutical Technology Editors

Validair Diamond Scientific (VDS) has invested in a new cleanroom at its Chester-le-Street headquarters. The in-house facility was designed to meet exacting requirements for research and fault-finding, as well as for use as a hands-on training resource.

VDS worked with Total Clean Air to design the cleanroom to be flexible in its performance and functionality, allowing for new experimentation, testing, and training processes. The cleanroom’s control system can be set to underperform, which will make the room fail and replicate real-life critical issues that may arise, allowing the field service teams to develop strategies and resolve these issues. The cleanroom will also be used to conduct research of fault-finding, rectification works, and test methodology comparisons.

"The room was installed in early June and is already helping us to improve procedures, refine techniques, and perform experiments and case studies that support our UKAS accreditation," said Steve Ward, managing director at Validair Diamond Scientific, in a press release.

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Validair Diamond Scientific has installed a new cleanroom for in-house testing, research, and training. 

Validair Diamond Scientific Installs New Cleanroom

Charles River announced on August 9, 2022 that it has received approval from the European Medicines Agency (EMA) to commercially produce allogeneic cell therapy drug products for distribution in Europe. Its contract development and manufacturing (CDMO) facility located in Memphis, TN received Good Manufacturing Practice (GMP) certification, joining the company’s existing GMP license for Investigational Medicinal Product (IMP) production.

The Memphis facility can now manufacture and ship drug products intended for distribution in the European Union, making it the first CDMO in North America to be awarded the license to do so. The approval follows an inspection by the cell and gene therapy experts from the Italian inspectorate, Agenzia Italiana del Farmaco (AIFA), performed on EMA’s behalf.

“We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy,” said Birgit Girshick, corporate executive vice president & chief operating officer, Charles River, in a company press release. “We are looking forward to continuing close partnerships with our clients, and supporting future commercial projects, bringing these potentially curative therapies to patients, sooner.”

Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA. 

Charles River Receives EMA Approval to Commercially Produce Allogeneic Cell Therapy Drug Products

Novartis announced on Aug. 11, 2022, that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Pluvicto (lutetium (177Lu) vipivotide tetraxetan) for the treatment prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

An emerging therapy approach, radioligand therapy may offer an alternative treatment option for some cancer patients, by combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). It is administered via the bloodstream and delivers targeted radiation to cancer cells in the body while aiming to limit damage to surrounding tissue.

“Far too many people are still dying each year from prostate cancer. Tragically, those diagnosed with metastatic prostate cancer will only have about a 1 in 2 chance of surviving 5 years,” said Steve Allen, acting chair of Tackle Prostate Cancer, in a company press release. “Today’s announcement of marketing authorization for lutetium treatment is another positive milestone for eligible patients and their families. There continues to be a real and pressing need for better treatments for people with advanced prostate cancer. This new approach is very welcome.”

The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain. 

UK Grants Marketing Authorization for Novartis’ Radioligand Therapy for Advanced Prostate Cancer 

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on August 15, 2022 that it has approved a bivalent version of Moderna’s COVID-19 vaccine that targets both the original and Omicron strains of the virus. The decision follows an endorsement of the booster from the UK’s Commission on Human Medicines, the government’s independent scientific advisory board.

According to an agency press release, the decision was based on a clinical trial which demonstrated that the booster triggers a strong immune response against the original COVID-19 strain and BA.1, the first Omicron strain. It also demonstrated a good immune response against Omicron sub-variants BA.4 and BA.5. Side-effects and overall safety profile were found to be the same as those in the original vaccine.

“The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives,” said June Raine, chief executive, MHRA, in the release. “What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve.”

“The virus, SARS-CoV-2, is continually evolving in order to evade the immunity provided by vaccines,” said Munir Pirmohamed, chair, Commission on Human Medicines, in the release. “This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine.”

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

UK Approves First Bivalent COVID-19 Booster Vaccine

CYTENA, a BICO group company and supplier of high-precision laboratory equipment for handling biological cells, recently unveiled the next generation of B.SIGHT, a fully automated single-cell dispenser. The B.SIGHT instrument is designed to streamline single-cell isolation in microbiology research, with emphasis placed on handling bacteria, yeast, and other microorganisms.

“The new B.SIGHT brings isolation of bacteria and yeast to the next level,” said Julian Riba, CEO, CYTENA, in an Aug. 8, 2022 company press release.. “This second generation single-cell dispenser is really the outcome of a great collaboration between our team and our customers.”

“The new instrument provides more automation, faster processing speeds, higher resolution, and precise dispensing,” said Hussein Hamzeh, the product manager in charge of B.SIGHT, in the release. “Researchers using the B.SIGHT not only will be able to accelerate microorganism isolation workflows but also significantly reduce plastic waste.”

CYTENA’s B.SIGHT cell dispenser is designed to streamline single-cell isolation in microbiology research.

CYTENA Unveils Fully Automated Single-Cell Dispenser for Microorganisms

New England Biolabs (NEB), a supplier of enzymes for molecular biology applications, announced the release of the Faustovirus Capping Enzyme (FCE), a messenger RNA (mRNA) capping solution, on Aug. 9, 2022. FCE is designed to improve capping efficiency and scalability for mRNA manufacturing workflows, including vaccine generation.

FCE is a single-subunit enzyme that contains the enzymatic activities to achieve a Cap-0 structure, which is necessary in eukaryotic mRNA maturation. According to a company press release, FCE is active over a broader temperature range (20 °C–55 °C) than traditional enzymatic capping approaches and demonstrates increased capping efficiency across a variety of mRNA 5´ structures.

"The biological versatility of mRNA continues to propel its rise as a therapeutic modality within infectious disease, oncology, and beyond," said Breton Hornblower, product portfolio manager, NEB, in the press release. "We are very excited to introduce FCE—an enzyme discovered at NEB—to our portfolio of products for mRNA synthesis. This new product offers a streamlined, scalable, and cost-effective solution for mRNA capping for both research and therapeutic applications."

"For large-scale mRNA production, I have always favored post-transcriptional enzymatic capping due to the significant advantages in terms of yield," said Andrew Geall, chief development officer, Replicate Bioscience, in the release. “This new enzyme with improved activity at lower temperatures promises great utility for the production of our large (9–16 kb) self-replicating RNA vector.”

According to the release, FCE is manufactured through environmentally friendly manufacturing practices, avoids the use of organic solvents and without producing significant volumes of hazardous waste. A good manufacturing practice-grade format of the enzyme will be available in early 2023.

The Faustovirus Capping Enzyme launched by New England Biolabs is designed to increase capping efficiency and scalability of mRNA manufacturing workflows.