Pharmaceutical Technology Editors

The European Medicines Agency (EMA) announced on June 8, 2022 that its Medicines Shortages Steering Group has created a list of critical authorized COVID-19 vaccines and treatments in order to monitor them for potential shortages. The list, which will be updated if changes in the pandemic situation occur, was created in consultation with the Medicines Shortages Single Point of Contact Working Party, the Emergency Task Force, and EMA’s Patients' and Consumers' Working Party and Healthcare Professionals' Working Party.

Companies that hold marketing authorizations of these medicines are required to update the agency with data on potential or actual shortages and available stock. Reports on estimated demand will also be provided by European Union Member States, enabling the agency to coordinate with the European Commission and EU Member States to prevent shortages of these critical medicines. EMA will work with authorization holders and national competent authorities to gather information about the medicines on the list.

Articles

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

EMA Adopts List of Critical COVID-19 Medicines

On June 8, 2022, Roche announced that the European Commission (EC) has granted conditional marketing authorization for Lunsumio (mosunetuzumab), a new off-the-shelf bispecific antibody for treating the most common slow-growing form of non-Hodgkin lymphoma, follicular lymphoma (FL). According to a company press release, mosunetuzumab is the first CD20xCD3 T-cell engaging bispecific antibody on the market.

The EC approval is specifically for the treatment of adult patients with relapsed or refractory FL who have received at least two prior systemic therapies. The approval is based on positive results from a Phase I/II study where the therapy demonstrated high complete response rates. The majority of complete responders maintained responses for at least 18 months. In addition, the therapy had favorable tolerability in people with heavily pre-treated FL.

Roche also has two ongoing Phase III studies investigating mosunetuzumab plus lenalidomide in second-line plus (2L+) FL treatment and mosunetuzumab plus Polivy (polatuzumab vedotin) in 2L+ treatment of diffuse large B-cell lymphoma (DLBCL), according to the press release.

The mosunetuzumab approval is Roche’s second approval in 2022 in the European Union for a lymphoma indication. In May 2022, the company received approval for Polivy in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone for use in previously untreated DLBCL (1).

“We are delighted that [mosunetuzumab] is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development, in the press release. “[Mosunetuzumab]’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated.”

“Having additional treatment options for people with follicular lymphoma, where multiple prior lines of therapy have failed, is critical to help them achieve better outcomes,” said Elizabeth Budde, haematologic oncologist and associate professor at City of Hope, a United States-based non-profit cancer center, in the press release. “It is exciting to have a new class of immunotherapy like [mosunetuzumab], offering a readily available, chemotherapy-free, and fixed-duration treatment, with great potential to provide durable remissions without the need to stay on treatment continuously.”

1. Roche, “Roche’s Polivy Combination Approved by European Commission for People with Previously Untreated Diffuse Large B-Cell Lymphoma,” Press Release, May 25, 2022.

Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

EC Approves Lunsumio, Roche’s Bispecific Antibody for Follicular Lymphoma

Rockwell Automation announced the grand opening of the Rockwell Experience Center at the Advanced Regenerative Manufacturing Institute (ARMI), in Manchester, N.H. on June 8, 2022. The Rockwell Experience Center is designed to teach its ARMI members how to increase delivery speeds by leveraging smart manufacturing in the scaling of regenerative medicine products. ARMI is a member-based, nonprofit organization whose goal is to advance the bioeconomy of the United States.

According to a company press release, the focal point of the center is a fully automated Cytiva equipment process train that is integrated with various Rockwell technologies, including a distributed control system, a manufacturing execution system, and a digital twin. The center also contains equipment from Air Science, Fester, and HID Global.

“To say that the addition of the Rockwell Experience Center at the ARMI|BioFabUSA facility will be impactful to the area of regenerative medicine would be an understatement,” said Dean Kamen, executive director of ARMI, in the press release. “By opening this center, we are able to demonstrate the baseline tools by which different types of human tissues and organs can be manufactured at scale. It's life-changing.”

“The Rockwell Experience Center demonstrates Rockwell’s long-standing support of ARMI and the role smart manufacturing technologies can play to bring regenerative medicine to scale,” said Blake Moret, ARMI board member and chairman, and CEO, Rockwell Automation, in the press release. “ARMI’s work training workers to compete and win in this fast-moving industry is an exciting model for manufacturing and for American competitiveness.”

The Rockwell Experience Center will teach ARMI members how to increase delivery speeds by leveraging smart manufacturing in the scaling of regenerative medicine products.

Rockwell Automation Opens Experience Center at Advanced Regenerative Manufacturing Institute 

Veranova, a contract manufacturing and development organization focusing on APIs, announced its launch as an independent company on June 1, 2022. Formerly known as Johnson Matthey Health, Veranova has rebranded itself following its acquisition by Altaris Capital Partners.

According to a company press release, the new name originates from the Latin words ‘vērus’ meaning ‘true’ and ‘nŏvus’ meaning ‘new’, representing the reliability and innovative approach of the company respectively. Veranova currently holds over 425 active patents and over the course of the past century has helped develop more than 100 APIs, including the first platinum-based drugs for cancer treatment.

Veranova is headquartered in Wayne, PA, with manufacturing operations in West Deptford, NJ; Devens, MA; North Andover, MA; Annan, UK; and Edinburgh, UK. The company also has manufacturing and R&D centers in Cambridge, UK, and Yantai, China.

Following the acquisition by Altaris Capital Partners, Johnson Matthey Health has rebranded as Veranova.

Johnson Matthey Health Rebrands as Veranova

Bio-Rad announced the launch of the SEQuoia Express Stranded RNA Library Prep Kit on June 6, 2022. The kit is designed to construct robust libraries for efficient RNA sequencing (RNA-Seq) workflows in comprehensive transcriptome profiling.

According to a company press release, the SEQuoia is a three-tube kit that uses a novel reverse transcriptase and a ligation-free adaptor addition chemistry to produce a reproducible, quantitative RNA-Seq library in three hours. The kit allows researchers to construct robust libraries that capture messenger RNA and long noncoding RNA (> 200 binding proteins) transcripts for differential gene expression analysis and novel transcript delivery.

“Current RNA library preparation approaches are time-consuming, complex, and potentially error-prone, with sample loss observed at each stage in processes with multiple steps,” said Simon May, executive vice-president and president, Life Science Group, Bio-Rad, in the press release. “Bio-Rad offers scientists an enhanced solution, combining its rapid NGS [next generation sequencing] library preparation with integrated data analysis to overcome these difficulties and enable the widespread adoption of RNA-based sequencing."

Bio-Rad’s SEQuoia Express Stranded RNA Library Prep Kit is designed to construct efficient RNA sequencing workflows.

Bio-Rad Launches SEQuoia Express Stranded RNA Library Prep Kit

Axol Bioscience, a provider of induced pluripotent stem cell (ISPC)-derived cells, media, and characterization services for life science discovery, announced that its IPSC-derived ventricular cardiomyocytes have undergone comprehensive 

 pro-arrhythmia assay (CiPA) validation on June 7, 2022. This assay showed that the cells were suitable for measuring cardiotoxicity, which offers scientists a robust cardiac model for drug discovery and screening.

CiPa is a working group developed by FDA to assess the utility of human iPSC-derived ventricular cardiomyocytes by reproducing cardiotoxicity in a dish. The assay tests cells with 28 compounds that are known to be cardiotoxic and induce the fatal arrhythmia “Torsades de Pointes”. According to an Axol press release, Clyde BioSciences, a contract research organization that specializes in cardiotoxicity assays, used this assay to validate Axol’s cardiomyocytes for cardiac safety testing.

“As a core member of the CiPA initiative, we’re pleased to have supported Axol’s cell development and helped the team assess the performance of its cardiomyocytes,” said Godfrey Smith, chief scientific officer, Clyde Biosciences, in the press release. “Having run the CiPA protocol on Clyde’s proprietary CellOPTIQ platform, and provided analysis and interpretation of the data, we confirm our data indicate that Axol’s cardiomyocytes meet the requirements for predictive 

Axol’s human iPSC-derived ventricular cardiomyocytes provide a continuous source of cells from the same genetic background for use in multiple experiments and a physiologically relevant 

 research model of human heart cells. This allows for reliable, repeatable cardiotoxicity testing for drug candidates at scale.

“Scientists need cells and reagents they can rely on to make meaningful assessments of drug candidate toxicity, before progressing candidates to the clinic,” said Liam Taylor, CEO, Axol Bioscience, in the press release. “We’re both excited and proud to demonstrate the suitability of our human iPSC-derived ventricular cardiomyocytes for toxicity testing. Axol’s stringent quality control standards mean we have the capability to produce reliable, validated cells that scientists can use to assess a compound’s cardiac liability and, ultimately, help to improve the drug discovery process.”

Axol Bioscience’s CiPA-validated ventricular cardiomyocytes can be used as a robust cardiotoxicity measurement tool.