Pharmaceutical Technology Editors

TCR² Therapeutics, a clinical-stage cell therapy company, announced on Nov. 1, 2021, that it would be expanding its manufacturing capacity by exercising an option on a second clean room at ElevateBio BaseCamp, a Cambridge, UK-based dedicated cell and gene therapy research, process development, and production center. This expansion complements TCR2’s buildout of clinical and commercial supply currently underway at its Rockville, MD, facility in the United States. The clean room addition will expand the company’s current good manufacturing (CGMP) capacity for clinical trials in 2022.

The timing of this capacity increase will coincide with a 2022 increase in demand from a Phase II clinical trial of TC-510, a mesothelin T-cell receptor (TCR) fusion construct (TRuC)-T cell therapy. According to a company press release, the TRuC platform is designed to recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens.

According to the release, this move is representative of TCR²’s long-term focus on developing clinical and commercial supply at the 85,000-ft² Rockville site. In conjunction with these plans, TCR² plans to cease manufacturing activities at the Cell and Gene Therapy Catapult in Stevenage, UK.

“This increase in [C]GMP manufacturing capacity at ElevateBio BaseCamp will ensure we are able to execute on the gavo-cel Phase [II] trial and the clinical plans for our next-generation TRuC-T cell products,” said Garry Menzel, president and CEO of TCR² Therapeutics, in the press release. “We are excited by the therapeutic potential of our lead clinical therapy gavo-cel and the emerging solid tumor pipeline reviewed recently at our R&D Day. Our strategy remains focused on continuous innovation providing multiple opportunities to save the lives of cancer patients.”

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TCR² Therapeutics will add a second clean room to their manufacturing operations.

TCR² Therapeutics Announces Expansion of US Manufacturing Capacity

GenScript USA, a life science research tools and services provider, announced on Nov. 2, 2021 that it opened a new highly automated facility for gene synthesis and plasmid preparation services in Piscataway, NJ. The new larger-than-50,000-ft

 facility expands the company's advanced gene synthesis services and is designed to mitigate supply chain risks in the United States for new vaccines, therapeutics, and innovations in synthetic biology. The new facility is GenScript's first automated manufacturing site in the US and represents a 10-fold increase in capacity.

"GenScript is extremely committed to supporting our customers as they expand globally, and this specialized laboratory and manufacturing facility allows us to deliver reliable products to them faster than ever before," said Ray Chen, president of GenScript USA Life Science Group, in a company press release. "Importantly, this site also gives our US customers additional production resilience in case of unexpected events, such as pandemics and changes in customs and trade regulations."

"We are fortunate to be located in an area where this in an abundance of talent and expertise," Chen added. "With this facility, we also intend to add 100–200 jobs in research and manufacturing over the next two years."

GenScript’s new gene synthesis center in Piscataway, NJ, is highly automated to accelerate production time and increase supply chain resiliency for biopharma and synthetic biology.

GenScript Opens New Gene Synthesis Center in New Jersey

Thermo Fisher Scientific has launched its new mass spectrometry (MS) instruments, workflows, and software, which the company is showcasing at the 69th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, held on Oct. 31–Nov. 4, 2021, in Philadelphia, Penn.

The Thermo Scientific Orbitrap Exploris MX mass detector allows biopharmaceutical laboratories to implement multi-attribute method (MAM) and perform intact analysis of monoclonal antibodies, conduct oligonucleotide mass determination, and carry out peptide mapping. The new system simplifies the transition of biotherapeutics from development to manufacturing and enables quality control (QC) customers to use the same method established earlier in a molecule's journey to commercialization, which accelerates the biopharma pipeline, the company stated in a Nov. 1, 2021 press release.

Labs can also benefit from reduced downtime, maintenance, and seamless method transfers, which further enhances efficiency. The new MS system also offers enhanced data quality, which can deliver high-confidence results even for users with limited mass spectrometric experience.

The Thermo Scientific MAM 2.0 workflow is designed to streamline biopharmaceutical characterization, process monitoring, and release testing by replacing multiple traditional assays with one comprehensive analysis that delivers insights on multiple critical product quality attributes. MAM 2.0 includes training, on-going support, and partnership that are required for enhancing laboratory analytical workflows across R&D, manufacturing, and QC environments. The new workflow enables the use of the same platform throughout an entire process, which allows for seamless transfer of data and knowledge across teams and departments. This capability removes bottlenecks often seen by organizations moving therapeutics from development to manufacturing, Themo Fisher stated in the press release.

The company’s offering for proteomic researchers is a combination of Thermo Scientific Proteome Discoverer 3.0 software and CHIMERYS, a cloud-native search algorithm for peptide identification by MSAID, a privately held informatics spin-off company from the chair of Proteomics and Bioanalytics at the Technical University of Munich, Germany. This offering will increase researchers’ ability to identify peptides and proteins and allow for a wider and deeper understanding of biological systems. The new system leverages artificial intelligence to reimagine the analysis of tandem mass spectra, which increases peptide coverage and quantitation capabilities.

The Thermo Scientific Compound Discoverer 3.3 software offers an enhanced peak detection algorithm and improved peak quality rating, which can provide scientists performing small-molecule analysis in metabolomics, environmental, food safety, clinical, and forensics laboratories much faster and more sensitive compound detection.

The Thermo Scientific BioPharma Finder 5.0 software increases analytical throughput and confidence through built-for-purpose data processing, curation, and customizable reporting, which are expected to create new capabilities for biotherapeutic workflows. Operating in a secure environment, the new software enables global collaboration and can be used across multiple application workflows, such as peptide mapping analysis, oligonucleotide analysis, intact mass analysis, and top-down analysis.

Finally, the Thermo Scientific LipidSearch 5.0 software has been upgraded to now support direct infusion workflows. The software features an extensive database of 1.5 million lipids, enabling real time monitoring in addition to more accurate lipid quantitation.

"The life science industry has stepped forward in an unprecedented fashion over the last 18 months, with academia and biopharma making key contributions to respond to the pandemic," said Dan Shine, senior vice-president and president, Analytical Instruments, Thermo Fisher Scientific, in the company press release. "We're honored to have played an essential role in this effort. The new instruments, software, and workflows that we're unveiling today will further support innovation across proteomics, biopharmaceutical characterization, and data acquisition while also ensuring that scientists can continue their critical ongoing research."

Thermo Fisher Scientific showcases its new mass spectrometry and chromatography solutions at the ASMS Conference on Oct. 31–Nov. 4, 2021. 

Thermo Fisher Launches New Mass Spectrometry and Chromatography Solutions

On Nov. 2, 2021, Lonza announced two acquisitions that will expand its exosomes development and manufacturing capabilities. The company will acquire the exosomes service unit from Exosomics, an extracellular vesicles biotech company, and a US-based exosomes manufacturing facility from Codiak BioSciences, a clinical-stage biopharmaceutical company specializing in exosome-based therapeutics.

Under the agreement with Exosomics, Lonza’s acquisition will include that company’s service team, service assets, and laboratories in Siena, Italy. Financial details of the deal were not disclosed. Lonza, a minority shareholder of Exosomics since 2017, will remain a shareholder after the acquisition closes.

With the Exosomics service unit acquisition, Lonza will gain access to expertise and capabilities in extracellular vesicle analytics and characterization. In addition to R&D, Lonza will expand the service offering from the Siena site to include a comprehensive suite of development and analytical services for exosomes.

"Lonza's acquisition reaffirms the recognition for Exosomics as a key player in Europe in the field of exosomes sciences. Exosomics will now focus on its original goal of pan-cancer screening and liquid biopsy applications in human diseases, still supported by Lonza as its most important industrial shareholder," said Antonio Chiesi, CEO, Exosomics, in a company press release.

Under the Codiak agreement, Lonza will acquire Codiak's Lexington, Mass., facility and become the strategic manufacturing partner for Codiak’s pipeline. Codiak will retain its pipeline of therapeutic candidates and its exosome engineering and drug-loading technologies. As part of the deal, Codiak will receive approximately $65 million of current good manufacturing practice (CGMP) manufacturing services in kind. Lonza in turn will gain worldwide access and sub-licensable rights to Codiak's high-throughput perfusion-based CGMP process for exosome manufacturing.

The companies also intend to establish a Center of Excellence for the development of exosome manufacturing technologies, which will leverage both companies’ expertise in advancing exosome production, purification, and analytics.

"We are excited about the collaboration we have established with Codiak BioSciences. Exosomes are emerging as a new modality for advanced therapies and could become the next frontier in biotherapeutics. Our collaboration with Codiak, one of the most advanced companies in this modality, is consistent with our strategy to advance this technology and will drive the advancement of the whole industry. We are committed to providing our capabilities to Codiak, alongside other customers in the exosome space,” said Alberto Santagostino, senior vice-president, head of Cell and Gene Technologies, Lonza, in a company press release.

“Creating an exosome manufacturing Center of Excellence with Lonza … accelerates productivity of our manufacturing platform and facilitates realization of its full potential by leveraging Lonza capabilities. Importantly for Codiak, this collaboration solidifies our capacity for expanded late-stage clinical and eventually commercial manufacturing as we advance our growing clinical pipeline. We are proud Lonza recognized Codiak’s pioneering work in the manufacture of engineered exosomes and look forward to our Center of Excellence helping to set new standards for the field,” said Doug Williams, CEO, Codiak BioSciences, in the press release.

Lonza is expanding its exosomes development and manufacturing capabilities with the acquisition of a service unit from Exosomics and a manufacturing facility from Codiak BioSciences.

Lonza Acquires Exosomics Service Unit and Codiak BioSciences Exosomes Manufacturing Facility

Novavax, a biotechnology company specializing in vaccines, and Serum Institute of India (SII), a vaccine manufacturer, announced on Nov. 1, 2021, that the National Agency of Drug and Food Control of the Republic of Indonesia granted Emergency Use Authorization (EUA) for Novavax’s COVID-19 vaccine. Shipments of Novavax's recombinant nanoparticle protein-based vaccine (which will be marketed as Covavax in Indonesia) are expected to begin immediately.

"The first authorization of Novavax's COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which, despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population," said Stanley C. Erck, president and CEO, Novavax, in a company press release. "This also marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase [III] clinical data demonstrating efficacy and a favorable safety profile. This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally."

According to the press release, because the vaccine is stored at 2° to 8° C, it can be safely placed in traditional vaccine storage facilities. Novavax believes that this can potentially help increase vaccine rates in hard-to-reach areas.

"Access to supply of a safe and highly effective vaccine, coupled with the ease of its distribution, should be a critical enabler to help Indonesia control the current coronavirus outbreak," said Adar Poonawalla, CEO, SII, in the press release. "We continue to work with urgency to ensure the first protein-based COVID-19 vaccine option in Indonesia is available for all awaiting its arrival."

In addition to this authorization, Novavax and SII have filed for vaccine authorization in India and the Philippines. They have applied for an Emergency Use Listing with the World Health Organization, and completed rolling submission for authorization with the United Kingdom, European Union, Canada, and Australia.

Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.

Novavax COVID-19 Vaccine Receives EUA in Indonesia

Takeda announced that it had exercised its option to acquire GammaDelta Therapeutics, a biotechnology company focused on using gamma delta (γx) T cells (T lymphocytes) for immunotherapy, on Oct. 27th, 2021. Following the acquisition, Takeda will have access to GammaDelta’s platforms that leverage γδT cells for the potential treatment of solid tumors and hematological malignancies.

Takeda and GammaDelta began a collaboration in 2017, which was developed to form GammaDelta’s novel γδ T cell therapy platforms. Now that the acquisition option has been exercised, Takeda will obtain GammaDelta’s allogeneic variable delta 1 (Vδ1) γδ T cell therapy platforms. This includes both blood-derived and tissue-derived platforms as well as early-stage cell therapy platforms. The deal is expected to close sometime in Q1 of 2022.

“Collaborating with scientific innovators with unique technology platforms and deep domain expertise, such as the GammaDelta team, allows Takeda to identify and accelerate the most promising approaches that can be developed into products to impact the lives of cancer patients,” said Christopher Arendt, head of oncology cell therapy and therapeutic area unit of Takeda, in a company press release. “Gamma-delta T cell-based therapies represent a differentiated approach to target both solid tumors and hematological malignancies, and we are eager to integrate GammaDelta’s cell therapy platforms into our immuno-oncology R&D efforts.”

“Through our work together, we’ve made great strides in developing our proprietary γδ T cell therapy platforms, which have enabled the development of a pipeline of innovative cell therapies and allowed for the advancement of our first program into Phase 1 clinical development.” said Paolo Paoletti, CEO of GammaDelta, in the press release. “This acquisition builds on the tremendous work of our talented team and provides the foundations to enable rapid development of a portfolio of innovative allogeneic cell therapies, focused on improving outcomes for patients with cancer.” 

Takeda’s acquisition of GammaDelta Therapeutics expands their immuno-oncology and innate immune cell therapy portfolio.