Pharmaceutical Technology Editors

The United Kingdom’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

Two of the bodies that MHRA will join are the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation (ICH), which are concerned with the harmonization of medicines and medical devices regulations globally. The third body is the Medical Devices Innovation Consortium (MDIC), which is an American public-private partnership aimed at progressing innovation and getting transformational medical technology to people sooner.

“We are delighted to join these three international organizations to collaborate on regulatory alignment that will help deliver safer, innovative, and more cost-effective medicines and medical devices to the people who need them sooner,” said Glenn Wells, chief international and partnerships officer at the MHRA, in a June 16, 2022 press release.

“We are currently building a world-leading regime for regulating medicines and medical devices in the UK that prioritises patient safety while fostering innovation, and we look forward to sharing expertise with partner organisations for the benefit of patients not just in the UK but worldwide.”

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MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

MHRA to Play Greater Role in International Medicines Regulation

The National Institute for Health and Care Excellence (NICE) has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes. Amarin, developer of Vazkepa, announced the news on June 10, 2022.

NICE’s recommendation applies to adult patients who are being treated with statins and who are at a high cardiovascular (CV) risk with elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]), LDL-C levels >1.04 mmol/L (and ≤ 2.60 mmol/L) and established cardiovascular disease (CVD). Vazkepa is the first treatment of its class to be recommended by NICE for CV risk reduction.

A trial involving more than 8000 patients, the REDUCE-IT Phase III clinical trial, demonstrated that there was a 25% relative reduction in the risk of future major adverse CV events when patients were treated with icosapent ethyl when compared with placebo.

“VAZKEPA offers an important scientific innovation for patients with CVD, and the results of the REDUCE-IT trial demonstrate the benefits of its use for optimizing the outcomes of patients at high risk of CV events, on top of treatments for traditional risk factors,” said Laurent Abuaf, senior vide-president and president of Europe, Amarin, in a company press release. “NICE’s recommendation will help to reduce the risk of CV events amongst a significant number of patients across England and Wales, and we are committed to working with all relevant stakeholders in the NHS [National Health Service] to offer this important new treatment option to patients with CVD.”

NICE’s final guidance is expected to be available in July 2022.

NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.

Icosapent Ethyl Gains Nod from NICE

Science and technology company, Merck, has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in process analytical technologies (PAT) for downstream processing (DSP), it was revealed in a June 14, 2022 press release.

Under the terms of the partnership, the companies will combine Merck’s bioprocess portfolio with Agilent Technologies’ advanced analytical products to extend real-time monitoring and automated process control of critical process parameters (CPPs) and critical quality attributes (CQAs) in DSP. PAT is key to enabling real-time release and Bioprocessing 4.0.

“The biopharmaceutical industry is on a rolling transformation to evolve and digitalize the next generation of bioprocessing to increase accessibility and lower the cost of biologics,” said Darren Verlenden, head of BioProcessing, Life Science business sector at Merck, in the press release. “By combining our advanced bioprocess portfolio with Agilent’s leading analytical solutions, we will be able to offer integrated capabilities for enhanced downstream process monitoring and control, bringing us one step closer to making the facility of the future a reality.”

“Integrating analytical capabilities and intelligence into bioprocessing enables the biopharma industry to accelerate biological drug development and manufacturing while supporting continuous manufacturing and real-time release,” added Stefan Schuette, vice president and general manager of Agilent´s Liquid Phase Separations Division. “This collaboration focuses on integrating Agilent’s new online liquid chromatography (LC) solution with Merck’s bioprocessing platforms and will support customers on their journey to develop and produce biological drugs faster, with greater confidence, and at lower cost.”

Merck has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in PAT for downstream processing.

Merck Collaborates with Agilent Technologies on PAT for Downstream Processing

According to a June 15, 2022 press release, a new polymer surface material has been invented by researchers at Chalmers University of Technology (Gothenburg, Sweden) that uses electrical signals to both capture and release biomolecules.

The new material may have an impact in the way that biomedicines are developed and could provide opportunities in the development of remote-controlled medication and electronic pills. The results of the research were published in a scientific journal, 

“Our polymer surfaces offer a new way of separating proteins by using electrical signals to control how they are bound to and released from a surface, while not affecting the structure of the protein,” said Gustav Ferrand-Drake del Castillo, doctor in Chemistry, Chalmers, CEO of Nyctea Technologies, and lead author of the study, in the press release.

The initial research behind the material was performed by Ferrand-Drake del Castillo while studying under the stewardship of Chalmers professor Andreas Dahlin within the university’s Division of Applied Surface Chemistry. The research project involved polymer surfaces that can change their state when the pH of the surrounding solution is adjusted—so, changing between neutral and charged.

“Shortly afterwards we discovered that we could use the electrical signals to control the binding and release of proteins and biomolecules, and that the electrode material works in biological solutions such as serum and centrifuged blood. We believe and hope that our discoveries may be of great benefit in the development of new medicines,” explained Dahlin, in the press release.

Additionally, the material was found to also work within biological fluids with the ability to counteract changes in pH values. Through this specific property of the polymer surface material, it may be possible for the researchers to create a new technique for implants and electronic pills, whereby the medicine is released within the body through electronic activation.

“You can imagine a doctor, or a computer program, measuring the need for a new dose of medicine in a patient, and a remote-controlled signal activating the release of the drug from the implant located in the very tissue or organ where it’s needed,” added Ferrand-Drake del Castillo. “Being able to control the release and uptake of proteins in the body with minimal surgical interventions and without needle injections is, we believe, a unique and useful property. The development of electronic implants is only one of several conceivable applications that are many years into the future. Research that helps us to link electronics with biology at a molecular level is an important piece of the puzzle in such a direction.”

A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.

Researchers Invent New Material that Can Capture and Release Biomolecules

Viral vector contract development and manufacturing organization (CDMO), Exothera, has announced its collaboration with clinical-stage genetic medicine company, LogicBioTherapeutics, and provider of upstream process solutions, Polyplus-transfection, for the development of a scalable adeno-associated virus (AAV) manufacturing platform.

The project, which was revealed in a June 15, 2022 press release, will be led by Exothera at its facility located in Jumet, Belgium. LogicBio will deliver its proprietary mAAVRx plasmid technology and AAV expertise, and Polyplus will provide access to its FectoVIR-AAV transfection reagent and its process development expertise for large-scale transient processing.

“Exothera’s team is proud to work with the experienced teams at biotech companies like LogicBio and Polyplus,” said Hanna Lesch, chief technology officer at Exothera, in the press release. “The success of AAV-based therapeutics requires a change in the manufacturing paradigm and through this collaboration, we aim to enable a new approach to consistently scale AAV manufacturing.”

“We believe our proprietary mAAVRx™ plasmid technology could dramatically help to improve manufacturing yields and consequently reduce AAV manufacturing costs,” added Matthias Hebben, global vice president, Technology Development at LogicBio, in the press release. “We are hopeful that the work done under this collaboration will be an important step forward in making gene therapy products accessible for a greater number of patients.”

“We are delighted to scale up AAV Viral vector Manufacturing processes to larger bioreactor volumes with innovators in the industry like Exothera and LogicBio,” said Roel Gordijn, chief commercial Officer at Polyplus, in the press release. “The collaboration will use a combination of state-of-the-art manufacturing technologies, innovative plasmid technologies and scalable transfection reagents which will make gene-therapy viral vector therapies affordable.”

Exothera, LogicBioTherapeutics, and Polyplus-transfection, are collaborating on the development of a scalable AAV manufacturing platform.

Exothera, LogicBioTherapeutics, and Polyplus Collaborate on Industrial-Scale AAV Manufacturing 

The online international partnering platform for CPHI China and P-MEC China has opened after China experienced gains in the CPHI Pharma Index, rising in its overall score by 7.2%, it was announced in a June 6, 2022 press release.

As the in-person event has been postponed until Dec. 20–22, 2022, the online partnering platform, which will run for two months, is of increased importance. The digital platform has been designed to help international companies pre-select new partners and to begin discussions at an earlier time point.

China’s largest year-on-year growth areas in the CPHI Pharma Index were in ‘solid dose manufacturing innovation’, ‘quality of bioprocessing’, and ‘API manufacturing’, which rose by 9.5%, 11%, and 7.4%, respectively. Furthermore, a rise in the number of biotech companies within the country is anticipated to power competition for manufacturing partners.

“There is a great deal of interest for partnering in China, as discovery and manufacturing continue to grow and, of course, it remains the largest producer of pharmaceutical ingredients—so in the absence of an in-person event we knew we had to offer alternatives,” said Laura Murina, brand manager at CPHI & P-MEC China, in the press release. “High quality partners are in great demand, and we wanted to simplify process of nurturing new contacts.”

CPHI China and P-MEC China has opened its online partnering platform after China experienced gains in the CPHI Pharma Index.