Pharmaceutical Technology Editors

Eppendorf’s new centrifuge, Centrifuge 5910 Ri, is designed to increase efficiency in the laboratory. Centrifuge 5910 Ri is the successor to the Centrifuge 5910 R, launched in 2018.

With the introduction of Centrifuge 5910 Ri in April 2021, Eppendorf now offers scientists advanced features to simplify and accelerate the centrifugation steps in their workflow. The new centrifuge features a touchscreen interface that allows for quick setting of desired parameters. Three levels of user management and new documentation options provide enhanced security and traceability. In addition, an optional connection to the new VisioNize Digital Lab Suite enables remote monitoring of the device, notification of alarms and events, and convenient access to important documents, such as certificates and operating manuals.

Other features include a large selection of rotors and adapters to facilitate a wide range of applications and a Universal rotor that saves time by allowing the centrifugation of 50-mL conical tubes, plates, and 250-mL bottles without the need to change the rotor, rotor buckets, or adapters. The combination of high capacity, performance, and intuitive user interface makes for fast, error-free operation and meets the needs of modern labs.

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Eppendorf’s new centrifuge is designed to increase laboratory efficiency, offering advanced features that simplify and accelerate centrifugation steps in the workflow.

Eppendorf’s Multipurpose Centrifuge 5910 Ri Accelerates Research

Albany Molecular Research, Inc. (AMRI) announced on April 30, 2021 that it has expanded its contract research, development, and manufacturing capabilities for orphan and rare disease products.

The expansion will include additional suites at its Albany, NY, facility for the manufacturing of batch sizes of 10–15 kilograms; expanded hydrogenation, filtering, drying, and analytical capabilities, along with added liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry instruments at its Grafton, Wis., facility; and formulation development and clinical sterile drug product manufacturing capabilities at its Glasgow, Scotland site, AMRI said in a company press release.

“AMRI is committed to making a difference for the innovators that meet the challenges of orphan drugs and, in turn, for the patients living with rare diseases,” said John Ratliff, CEO, AMRI, in the press release. “AMRI’s scientists and operators dedicate both hearts and minds to these programs, including our regulatory and intellectual property professionals who work closely alongside customers to navigate the complex landscape associated with orphan designations and our scientists who can manage the complexity of these innovative products. Our teams deliver seamless programs for orphan products from R&D through manufacturing with a passionate commitment to ‘right first time’ throughout.”

AMRI will increase R&D and manufacturing capabilities for orphan and rare disease products.

AMRI Expands R&D and Manufacturing Sites

Meissner Filtration Products, an advanced microfiltration products and single-use systems manufacturer, announced on April 30, 2021 that it was awarded a $13.4 million contract from the US Biomedical Advanced Research and Development Authority (BARDA) to expand production capacity for products necessary for the manufacturing of COVID-19 vaccines and therapeutics.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space and support areas, as well as using inventory management systems, Meissner said in a company press release.

“Meissner has experienced substantial demand for our products associated with federally funded vaccine and therapeutics manufacturing efforts,” said Christopher Meissner, CEO of Meissner, in the press release. “It has been incredibly fulfilling for our organization to be able to make a direct impact fighting this pandemic, and this contract serves to amplify and accelerate those efforts.”

“While we have seen increased demand on the basis of COVID-19 vaccines and therapeutics, our products are also a key piece in the development and manufacture of other lifesaving medicines, so it’s critical that we able to support all of our customers through this period and in the future,” added Max Blomberg, executive director of Operations, Meissner, in the press release. “This expansion, which will provide a substantial capacity augmentation for our Camarillo campus, is just the latest in our continuing work to ensure we scale with our clients’ needs.”

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

Meissner Filtration Products Awarded Contract from BARDA for COVID-19 Production Capacity Expansion

GlaxoSmithKline (GSK) has received approval from both the European Commission (EC) and FDA for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for treating endometrial cancer. The company announced the EC approval on April 23, 2021 and FDA announced its approval on April 22, 2021.

In Europe, the EC approved the biologic for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. This approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe, according to the GSK press release.

The approval in Europe is based on results from a multi-cohort study, in which treatment with dostarlimab resulted in an objective response rate of 43.5% and a disease control rate of 55.6%.

“Women with recurrent endometrial cancer, or advanced disease that has progressed on or after chemotherapy, currently have limited treatment options and a poor prognosis. [The] approval of dostarlimab means that for the first time in Europe, these women will have access to a new, innovative, and much-needed therapy,” said Hal Barron, MD, chief scientific officer and president R&D, GSK, in the company press release.

Similarly, FDA approved Jemperli for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature (dMMR, which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.

Jemperli received priority review designation and breakthrough therapy designation for this indication. The biologic was approved under FDA’s accelerated approval pathway, which allows the agency to approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. The agency stated in its press release that further clinical trials may be required to verify and describe anticipated clinical benefits of Jemperli, and the sponsor is currently conducting these trials in additional patients with dMMR endometrial tumors.

“Today’s approval of Jemperli is evidence of [FDA’s] progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research, in the agency’s press release. “This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”

GSK stated in its press release that it is also studying dostarlimab for endometrial cancer in earlier treatment lines and in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

GSK Gets EC and FDA Approval for Endometrial Cancer Biologic, Jemperli

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted an approval for Vazkepa (icosapent ethyl) to be used as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients in Great Britain.

According to an April 22, 2021 press release from Amarin Corporation, MHRA’s license, which has rapidly followed the European Commission’s marketing authorization decision, is among the first under the new ‘reliance’ route post-BREXIT. Icosapent ethyl has been identified as a new active substance that likely features multi-factorial mechanisms of action, with the mechanisms of action contributing to the reduction of cardiovascular events not completely understood.

The regulatory authority’s decision has been based upon clinical trial results of the REDUCE-IT study, in which 8179 statin-treated adult patients with moderately elevated triglyceride levels were followed for a median duration of 4.9 years. In the study, icosapent ethyl achieved the primary composite endpoint and demonstrated risk reduction in the key secondary composite endpoint. More information can be found in the company’s press release, sourced below.

“The REDUCE-IT study shows icosapent ethyl could reduce CV [cardiovascular] events and has the potential to change the way residual cardiovascular risk is treated,” said Professor Gabriel Steg, co-author of the REDUCE-IT study and chief, Department of Cardiology at Hôpital Bichat, Paris, in the press release. “This authorization of icosapent ethyl can make a difference to patients who are at high-risk of suffering from a heart attack or stroke. Eligible patients can be confident we have a new treatment that is backed by evidence-based data and European guideline recommendations.”

“We began developing icosapent ethyl in Europe more than a decade ago. We are very grateful to the many patients and physicians who contributed to the development and clinical study of icosapent ethyl. Icosapent ethyl can help to reduce strokes, heart attacks, and other major cardiovascular events in high-risk patients across Europe,” added John Thero, president and CEO of Amarin, in the press release. “We are dedicated to a rethinking of cardiovascular disease risk reduction in Europe with an emphasis on preventative care. We will work tirelessly throughout Europe to make icosapent ethyl available to all patients who may benefit from this therapy.”

The UK’s Medicines and Healthcare products Regulatory Agency has granted an approval for Vazkepa (icosapent ethyl) to be used as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients in Great Britain.

MHRA Grants Approval for Use of Vazkepa in Great Britain

According to an April 26, 2021 press release, the European Medicines Agency (EMA) and the European Centre for Disease Prevention (ECDC) have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

The safety, effectiveness, and impact of COVID-19 vaccines being used in the European Union (EU) and European Economic Area will be evaluated in large-scale studies to monitor how the vaccines are performing in real-world settings. These EU-wide observational studies will be key in the creation of evidence to support the continuous assessment of the benefits and risks of the vaccines, and to inform any decision-making on the use of the vaccines in national or regional strategies.

EMA and ECDC will work together on the coordination and oversight of several observational studies that will be funded from the EU budget and performed in several EU countries. EMA will be the lead on monitoring safety of the vaccines and ECDC will take the lead on the effectiveness of the vaccines. A Joint Advisory Board, which is co-chaired by EMA and ECDC, will support the work via consultation on prioritization, design, conduct, and interpretation of the studies.

“Observational research is an important pillar in the post-marketing surveillance of COVID-19 vaccines and increased EU level collaboration is needed so that member states can join forces and organise large studies that meet the needs of both medicines regulators and national institutes for public health and vaccination,” said Emer Cooke, EMA’s executive director, in the press release. “EMA and ECDC are ideally placed to coordinate such studies and will work closely together, alongside the European Commission, to involve national competent authorities of the member states in the set-up, execution, and assessment of the data.”

“I am very happy to launch this new scientific forum and joint work that will provide important insights and evidence to shape public health strategies and vaccination policies in the member states,” added Andrea Ammon, ECDC director, in the press release. “This new model of collaboration brings medicine regulators and public health authorities closer together and establishes processes towards a more permanent, sustainable collaboration platform for monitoring vaccine safety and effectiveness. This work has its underpinnings in the Council Recommendation of 2018 and will continue to deliver results for the benefit of all Europeans for years to come.”

The European Medicines Agency and the European Centre for Disease Prevention  have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.