Pharmaceutical Technology Editors

The National Institute for Health and Care Excellence has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with hepatocellular carcinoma (HCC).

According to a Feb 26, 2021 press release from Boston Scientific, based on the results of more than 100 clinical studies, the effectiveness of TheraSphere to improve tumor response in all stages of liver cancer has been proven. The targeted treatment, which is commonly known as selective internal radiation therapy (SIRT), can be used as an outpatient procedure.

“Outpatient treatment options are important for patients diagnosed with liver cancer as they are especially vulnerable to complications from COVID-19 and the use of TheraSphere can help avoid risk of exposure to infection in the healthcare setting,” said Jane Healy, vice-president Peripheral Interventions, EMEA at Boston Scientific, in the press release. “We look forward to bringing this proven treatment option to a greater number of patients with HCC, to improve their chance of survival against this disease in today’s challenging healthcare landscape and for many years to come.”

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NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.

NICE Recommends TheraSphere as Treatment for HCC

Eli Lilly and Company announced on Feb. 25, 2021 that it has entered into a collaboration and licensing agreement with Welldoc to integrate its digital insulin management solution, BlueStar, into Lilly’s connected insulin solutions. 

Under the terms of the agreement, the companies will create a new version of the management solution that will feature insulin dosing data for Eli Lilly insulins. In the first version of the platform, a data transfer module will attach to the top of a prefilled, disposable insulin pen, Eli Lilly said in a company press release. Eli Lilly also plans to develop a fully disposable connected insulin pen for future versions. The app will allow healthcare providers to provide insight regarding diabetes care.

Both companies will submit their pieces of the new management solution to FDA in 2021; Lilly will submit the data transfer module and Welldoc will submit the new app. If approved, Eli Lilly will commercialize the pen platform in the United States and consider launching to other regions, according to the press release.

"Insulin dosing data are a critical piece of the diabetes management puzzle for people who use insulin to manage their diabetes, and Lilly has made significant progress in developing connected insulin pen solutions to provide access to those data," said Kevin McRaith, president and CEO of Welldoc, in the press release. "Our software will now bring all of the most important diabetes data directly into the hands of people living with the condition, their caregivers, and their healthcare providers. Bringing various elements of a patient's care under one platform is critical for those who are managing multiple comorbidities and providers who are working to effectively manage population health.”

"Today, less than half of people who use insulins are achieving their target A1C goals. We want to simplify the experience of using insulin by integrating our medicines with the most innovative technology available," added Marie Schiller, vice president of product development for Connected Care and Insulins at Eli Lilly, in the press release. "We are excited to collaborate with Welldoc. Together, we will combine their advanced software capabilities and expansive insulin management features with our connected insulin pen solutions with the goal of easing the burden of diabetes care on people living with the condition."

The companies will integrate Welldoc’s digital insulin management solution, BlueStar, into Eli Lilly’s connected insulin solutions.

Eli Lilly and Welldoc to Collaborate on New Digital Insulin Management Solution

Yokogawa Electric Corporation, a Japanese electrical engineering and software company, and Integrated Commissioning and Qualification Consultants (ICQ Consultants), a US-based biotechnology company, announced on Feb. 24, 2021 that they have entered into a partnership through which ICQ Consultants will provide consulting and engineering services for the installation, maintenance, qualification, and support of Yokogawa's bioreactor systems and related products in the US.

Through the collaboration, Yokogawa will gain access to ICQ Consultants’ engineering and laboratory expertise in the biopharmaceutical market to launch its bioprocess technologies in the US, Yokogawa said in a company press release. Yokogawa’s first portfolio product from the partnership is the Advanced Control Bioreactor System BR1000. Released on Jan. 8, 2021, the new system works to automate lab-scale mammalian cell culture with real-time monitoring and advanced process control.

"We are very excited to join Yokogawa in this strategic partnership agreement to help facilitate the support of their bioreactor systems and related products throughout the United States,” said Michael Bogan, president of ICQ Consultants, in the press release. “As ICQ Consultants continues to expand operations across the country, we are poised to further develop lasting relationships, which has been a key factor in our ongoing success. I look forward to working with Yokogawa on this unique and collaborative opportunity.”

“Alliances with industry experts like ICQ Consultants are vital to gain expertise and penetration in the high growth biopharmaceutical market,” added Hiroshi Nakao, a Yokogawa vice president and head of the company's Life Innovation Business Headquarters, in the press release. “ICQ Consultants’ engineering and technical knowledge in drug manufacturing will support our innovative new bioreactor and bioprocess technologies and help position Yokogawa for rapid sales and market leadership in the emerging bio-industrial autonomy sector."

Under the terms of the partnership, ICQ Consultants will provide consulting and engineering services for the installation, maintenance, qualification, and support of Yokogawa's bioreactor systems and related products in the US.

Yokogawa Electric Corporation and ICQ Consultants to Collaborate on Bioreactor Systems Consulting and Engineering

Albany Molecular Research (AMRI) announced on Feb. 25, 2021 that it has been selected to provide support for the development and manufacture of lipid excipients for the Pfizer-BioNTech COVID-19 vaccine.

AMRI has been providing development, scale-up, and manufacturing services for the vaccine at its global R&D production sites, demonstrating its operational flexibility and expertise, AMRI said in a company press release. The company will now join the network of approved manufacturers of the lipid excipients and contribute to the efforts to increase supply.

“We are proud to support Pfizer and BioNTech in this global effort to halt the spread of COVID-19 and prevent further occurrence of this devastating disease,” said John Ratliff, CEO, AMRI, in the press release. “Our response to this pandemic will continue to be both rapid and reliable, reflecting our dedication to quality delivery and scientific integrity. We are committed to playing a vital role in ending this pandemic, from our work in support of antivirals and vaccines to the continued production of essential medicines used for COVID-19 patients.”

The company will join the network of approved manufacturers of the lipid excipients. 

AMRI to Develop and Manufacture Lipid Excipients for Pfizer-BioNTech COVID-19 Vaccine

Celonic Group, a contract development and manufacturing organization (CDMO), announced on Feb. 25, 2021 that it has entered into a long-term lease agreement for a new production site and office space at the Novartis-operated Life Science Park Rheintal in Stein, Switzerland.

The 91,500-ft2 site will house development and GMP production capacities for cell and gene therapies, next-generation vaccines, and biopharmaceuticals, to support clients from early clinical trials through commercialization, Celonic said in a company press release. The expansion will be completed in two phases and will add up to 20 GMP cleanroom suites and offices, along with laboratories for process development, method development, and quality control services.

“This expansion to the Life Science Park Rheintal demonstrates our commitment to address the growing demand for cell and gene therapy manufacturing. With its unique location and on-site services, this state-of-the-art facility will further boost Celonic’s expansion into the cell and gene space and enable us to offer large-scale ATMP (advanced therapy medicinal products) GMP manufacturing from early 2022,” said Konstantin Matentzoglu, CEO of Celonic, in the press release. “We are looking forward to establishing a world-class cell and gene therapy facility in this fast-developing life sciences hub operated by Novartis.”

The site will house development and GMP production capacities for cell and gene therapies, next-generation vaccines, and biopharmaceuticals, to support clients from early clinical trials through commercialization.

Celonic to Establish New Cell and Gene Therapy Production Site in Switzerland

VIVEbiotech, a gene transfer technologies contract development and manufacturing organization located in Spain, announced on Feb. 24, 2021 that it will be expanding its manufacturing capabilities with new facilities.

The expansion aims to increase the company’s production capacity and advance optimization of its manufacturing processes, the company said in a press release. A versatile design will allow flexible cleanroom configurations. Additionally, the facility expansions will provide the company with added space for upcoming projects.

“The continued expansion of the gene and cell therapy sector has resulted in an increase in the number of clinical trials, as well as additional trials moving into later-stage development. In turn, this has led to a continued increase in the demand for both lentiviral vectors, as well as expertise in their use and application,” said Gurutz Linazasoro, CEO of VIVEbiotech, in the press release. “This demand for lentivirals is increasing for therapies throughout the clinical stages and into commercialization. A higher number of early-stage cell and gene therapy developers now are requiring a longer-term partner in lentiviral supply that provides continuity throughout the clinical stages. VIVEbiotech has responded to this growth in requirement from the cell and gene therapy sector by constructing new facilities with increased cleanrooms to cater for the demand, and a renewed focus on innovation to continue leading the development of lentiviral vectors. This will enable us to utilize our sole lentiviral expertise and specialization to contribute towards moving gene therapies through the clinical process and to patients in a range of different conditions.”

The new facilities are set to be completed in April 2021, with the transition between the facilities completed by October 2021.

The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.