Pharmaceutical Technology Editors

Catalent announced on April 21, 2022 that it is planning a multi-year $350 million investment at its facility in Bloomington, Ind. to expand its biologics drug substance and drug product manufacturing capabilities.

The project will include the additions of new 2000-liter single-use bioreactors, syringe filling lines, and additional lyophilization capacity supported by quality control laboratories and complex automated packaging. The packaging space will have high-speed, automated cartoning, and auto-injector device assembly capabilities. These new capabilities are expected to be fully operational later in 2022.

The project aims to be completed in 2024 and is expected to add more than 1000 new jobs to Catalent’s Bloomington workforce. The expansion follows a series of recent investments in Catalent Biologics’ global network, including the modernization of its fill/finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility near Oxford, United Kingdom.

“We continue to see strong growth in demand for biologics development and manufacturing with a deep pipeline across multiple indications,” commented Mike Riley, president of biotherapeutics at Catalent. “These investments will enable us to expand our flagship Bloomington facility and extend our leadership as one of the largest and most comprehensive global centers for integrated manufacturing capabilities. The site offers highly flexible and scalable solutions to companies developing new biological drugs, vaccines, RNA therapies, and other innovative treatments for patients around the world.”

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Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.

Catalent to Invest $350 Million in Manufacturing Facility in Bloomington, Indiana

The European Investment Bank (EIB) has provided €15 million in funding to IRBM SpA, an Italian company specializing in biomedical and pharmaceutical solutions to combat diseases. The funding will be used to expand medical research and development to fight coronavirus and other infectious diseases.

The project is being financed via the InnovFin initiative, in cooperation with the European Commission, and funded by the European Union’s Horizon 2020 research and innovation program. The project will focus on expanding vaccine production, including quality control and assurance with state-of-the-art equipment and technologies, between 2022 and 2024.

According to EIB, IRBM’s Italian research infrastructure is among the largest in Europe, which will aid in a larger-scale development of vaccines to alleviate the ongoing global vaccine shortage. The project’s goals are also to help ensure a more resilient global response to potential future epidemics.

“We are proud that the EIB has decided to provide this financing to support IRBM Group's ambitious development plans which will help the world fight against coronavirus and other infectious diseases,” said Piero Di Lorenzo, president and CEO of IRBM. “The company is currently enhancing its role in the life science sector via the expansion of highly innovative research and manufacturing capabilities, the hiring of key staff with international expertise and through strategic acquisitions.”

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

EIB Provides €15 million to IRBM

Otsuka Pharmaceutical announced on April 15, 2022 that it has entered an exclusive, worldwide license agreement with Osaka University to use R8H283, a novel antibody that recognizes the CD98 heavy chain identified by Osaka University, in its pharmaceutical and medical products.

An Osaka University research group led by Professor Naoki Hosen (Department of Hematology and Oncology, Osaka University Graduate School of Medicine) identified R8H283 as an anti-CD98 heavy chain antibody. CD98 heavy chain is a protein expressed in a wide range of tissues, but R8H283 specifically binds to multiple myeloma. R8H283 was shown to have significant anti-tumor effects in an animal model study, Osaka University announced in February 2022.

Under the terms of the agreement, Otsuka will make an upfront payment, development and sales-milestone payments, and sales royalties to Osaka University. Otsuka will utilize R8H283 exclusively to perform non-clinical research, clinical development, manufacturing, and commercialization.

"R8H283, a unique multiple myeloma-specific antibody, has the potential to be applied not only to antibody drugs but also to various other medical products, including CAR-T cells,” said Professor Naoki Hosen in a press release. “In addition, this antibody could be applicable to other types of cancer. We believe that this agreement is very important in bringing these products to patients as soon as possible. We will continue our efforts to conduct research that will be useful in the treatment of patients suffering from cancer."

Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.

Otsuka Pharmaceutical and Osaka University Enter Exclusive License Agreement 

Takeda announced on April 18, 2022 that its treatment TAKHZYRO (lanadelumab-flyo) injection single-dose prefilled syringe is now available in the United States to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

HAE is a rare genetic disease that causes recurrent attacks of swelling in various parts of the body, which can be burdensome, debilitating, and potentially life-threatening. The treatment is ready-to-use and is easier to administer as it requires fewer preparation steps than a single-dose vial. FDA approved the treatment on Feb. 8, 2022.

“HAE attacks are unpredictable, debilitating, and in some cases life-threatening, adding uncertainty and complexity to the daily lives of those living with this disease and their families,” said Dr. William Lumry, allergy immunology specialist, clinical professor of internal medicine, University of Texas Southwestern Medical School

in a press release. “After many years in practice witnessing the ups and downs of this disease, I welcome any opportunity to simplify the process of administering an effective prevention therapy for people living with HAE."

“By introducing TAKHZYRO prefilled syringe to the HAE community, our aim is to continue to enhance the patient experience. With this advancement, those taking TAKHZYRO can now live their life with a ready-to-use option that requires fewer steps and less waste than when using the single-dose vial to receive their injection,” said Cheryl Schwartz, senior vice president, Rare Disease Business Unit at Takeda Pharmaceutical Company Limited, in the release. “Over the coming months, we will be working with patients and their specialty pharmacies as they are ready to make the transition.”

Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.

Takeda’s TAKHZYRO Prefilled Syringe Now Available for Patients with Hereditary Angioedema

Amoy Diagnostics Co. (AmoyDx), a China-based molecular diagnostics company, announced on April 18, 2022 that it has entered into a Master Collaboration Agreement with AstraZeneca. The agreement will enable the companies to develop and commercialize AmoyDx assays that may cover any type of indication or biomarker for companion diagnostic (CDx) use with AstraZeneca medicines.

One of the first projects to be initiated under the agreement is co-developing a CDx to identify prostate cancer patients with Homologous Recombination Repair (HRR) gene mutations in China, the European Union (EU), and Japan. Another prioritized project will be to develop a CDx to identify breast cancer patients with BRCA gene mutations in the EU for Lynparza monotherapy.

HRR and BRCA mutations are important biomarkers that can inform potential treatment options, including a PARP inhibitor such as Lynparza, which was developed jointly by AstraZeneca and MSD. Lynparza is meant for the treatment of advanced ovarian, breast, prostate, and pancreatic cancers.

“We are very pleased to announce today that we are further developing our partnership with AstraZeneca by entering into a master collaboration agreement,” said Li-Mou Zheng, PhD, founder and chairman of AmoyDx, in a press release. “AmoyDx is a trustworthy CDx co-development partner with rich expertise in R&D, Regulatory Affairs, and Commercialization globally. AmoyDx and AstraZeneca share the common core value of prioritizing patients, and we will work together to accelerate the contribution for the benefit of patients.”

AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.

AmoyDX and AstraZeneca Enter Master Collaboration Agreement

Thermo Fisher Scientific has introduced its new GMP-manufactured Gibco CTA TrueCut Cas9 protein to support genome editing for research and manufacturing applications. The proteins are manufactured with 

) standards in mind, including traceability documentation, aseptic manufacturing, and safety testing.

High-quality ancillary materials and documentation are critical as researchers using genome editing tools move from basic research to clinical settings, including Chimeric antigen receptor (CAR) T-cell therapy research. The Gibco CTS TrueCut Cas9 protein provides greater than 90% efficacy in human primary T-cells, making it a promising solution for CAR T-cell therapy research, according to the company. Along with the company’s recently launched Gibco CTS Xenon Electroporation System, the GMP-manufactured Cas9 protein can aid Thermo Fisher in supporting researchers across the autologous T-cell workflow.

"As genome editing quality and regulatory requirements continue to evolve, we are focused on providing solutions to meet scientists' needs as they transition from the bench to the clinic," said Brandon Pence, vice president and general manager of cell biology at Thermo Fisher Scientific, in a press release. "By adding the Gibco CTS TrueCut Cas9 Protein to our portfolio of genome editing solutions, we can now support scientists in their journey to develop personalized CAR T-cell therapeutics."

Thermo Fisher Scientific has launched its first GMP-manufactured Cas9 protein for clinical genome editing research.