Pharmaceutical Technology Editors

On August 11, 2021, Precision NanoSystems (PNI) announced an expansion of its global headquarters with a 75,000-ft

 facility. The facility, located in Vancouver, British Columbia, Canada is currently under construction and expected to be completed in the fourth quarter of 2022.

The company’s new genetic medicine good manufacturing practice biomanufacturing center will be housed at this site, which will support drug development through clinical phases as well as Canada’s pandemic efforts by offering manufacturing for RNA vaccines. In addition, PNI intends to expand capabilities into clinical manufacturing of RNA vaccines and therapeutics.

The biomanufacturing center was partially funded with CA$25.1 million (US$20.1 million) from Canada’s Strategic Innovation Fund.

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PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.

Precision NanoSystems Expands GMP Biomanufacturing Center 

Lumen Bioscience, a clinical-stage biopharmaceutical company, announced in an August 11, 2021 press release the results of a research collaboration with Google that applied machine learning (ML) to significantly advance the scalability of spirulina-based biologic drugs. Lumen’s platform builds on discoveries of engineering spirulina and subsequent development of a low-cost system to manufacture them at large-scale under biopharmaceutical-grade current good manufacturing practice controls.

In a biomanufacturing system like Lumen’s—where the growth media includes water and mineral salts—the number of potentially interacting variables is too vast to explore with one-factor-at-a-time experimentation, according to Lumen’s press release. The ML application helps to improve the productivity process that took decades for older biomanufacturing platforms like yeast, 

In the paper, the application of ML to increase spirulina productivity using Bayesian black box optimization to rapidly explore a 17-dimensional space containing several environmental variables, including pH, temperature, and light spectrum and light intensity is detailed. The research is titled “Machine Learning Optimization of Photosynthetic Microbe Cultivation and Recombinant Protein Production” and is pending peer review.

“The combination of two pioneering innovations—the machine-learning of Google and our spirulina-based therapeutics production—brings us even closer to a fully optimized approach that could have a major impact on devastating diseases globally,” said Jim Roberts, co-founder and chief scientific officer of Lumen Bioscience, in a press release. “We believe this paper is the first to describe the application of AI techniques to biologics manufacturing. We look forward to the future implementation of these practices, as supported with funding from the Department of Energy, to provide mucosally and topically delivered biologics for highly prevalent diseases that, until now, have been infeasible due to the cost and scaling challenges of traditional biomanufacturing platforms.”

The research was led by Caitlin Gamble, Lumen and Drew Bryant at Google Accelerated Science and was funded in part by the Bill & Melinda Gates Foundation. Lumen Bioscience also received $2 million in additional grant funding from the Department of Energy for further development of these research findings.

The companies announce the results of a research collaboration that applied machine learning to significantly advance the scalability of spirulina-based biologic drugs.

Google and Lumen Bioscience Apply Machine Learning to the Manufacture of Spirulina-Based Biologic Drugs

Eli Lilly and Company and Incyte announced on Aug. 3, 2021that an additional cohort of 101 adult patients in a sub-study within a clinical trial showed a reduction in mortality when treated with baricitinib in addition to standard care. In the sub-study, patients with COVID-19 on mechanical ventilation (ECMO), who received baricitinib plus standard of care were 46% less likely to die by the 28th day, compared to patients who received placebo plus standard of care.

The study also showed that approximately 39.2% of patients who received baricitinib plus standard care died on day 28 versus 58% of patients who received placebo plus standard care. On day 60, 45.1% of patients who received baricitinib plus standard care died as compared to 62% of patients who received placebo plus standard care. The findings were consistent with the mortality reduction observed in the overall clinical trial (COV-BARRIER) patient population. The dosing involved 4 mg of baricitinib once daily.

Lilly intends to publish detailed results from this additional sub-study in a peer-reviewed journal, the company stated in a press release. New data from the sub-study will be shared with regulatory authorities in the United States, European Union, and other countries.

FDA broadened the Emergency Use Authorization (EUA) for baricitinib on July 28, 2021, allowing for treatment with or without remdesivir. The EUA includes baricitinib for treatment of COVID-19 in hospitalized patients two years of age or older requiring supplemental oxygen or non-invasive or invasive ECMO.

"As additional data from [the] COV-BARRIER [sudy] become available, it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that baricitinib represents an important treatment option for this vulnerable group of patients in this constantly evolving pandemic," said E. Wesley Ely, professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University Medical Center and co-principal investigator of the COV-BARRIER study, in the press release.

Eli Lilly and Company and Incyte have announced promising results that patients with COVID-19 on mechanical ventilation saw a reduction in deaths with the addition of baricitinib treatment.

Lilly and Incyte Announce Promising COVID-19 Study Results with Baricitinib 

According to an August 10, 2021 press release, Almac Sciences, a member of the Almac Group, has signed a manufacturing agreement with Swedish biotech company, Pila Pharma, for the production of the API XEN-D0501— a highly selective and very potent small molecule TRPV1 antagonist. Almac Sciences will manufacture XEN-D0501 from its global headquarters in Northern Ireland. The API was previously in development by Bayer Healthcare and Xention/Ario Pharma and was acquired by Pila Pharma in March 2016.

The TRPV1 target has demonstrated applications across pain and inflammatory diseases and possibly in diabetes. After being acquired by Pila Pharma, XEN-D0501 demonstrated good safety results as well as efficacy, (i.e., a statistically improved endogenous insulin response to oral glucose versus placebo in patients with type 2 diabetes).

“The availability of new API is key for us to be able to conduct planned three-month toxicology studies, that are in turn a prerequisite for initiating our main goal, conducting a clinical phase 2b study with XEN-D0501 in type-2 diabetics,” said Dorte X. Gram, CEO of Pila Pharma, in a press release.

“Almac Sciences is delighted to be working with Pila Pharma and supporting their API manufacture,” said Tom Moody, VP technology development and commercialization, Almac Sciences and Arran Chemical Company, in a press release. “The project showcases deployment of our technology platforms including integration of green chemistries and we look forward to further opportunities in this space.”

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

Almac Group and Pila Pharma Sign Manufacturing Agreement 

Bayer AG has acquired Vividion Therapeutics, a US-based biopharmaceutical company, for an upfront sum of $1.5 billion dollars. The acquisition strengthens Bayer’s small-molecule capabilities and expands the company’s reach into new modalities. An additional $500 million could be paid if certain potential success-based milestones are reached.

Vividion Therapeutics specializes in using novel discovery technologies to discover traditionally undruggable targets. Vividion’s chemoproteomic screening platform can identify previously unknown binding pockets on well-validated protein targets by screening chemical probes against the entire human proteome to assess selectivity.

Their lead programs include multiple precision oncology and immunology targets, along with ongoing efforts on a transcription factor NRF2 antagonist for the treatment of NRF2 mutant cancers. Additionally, NRF2 activators for various inflammatory diseases (such as irritable bowel disease) are being investigated.

The acquisition is anticipated to close in the third quarter of 2021. Once the acquisition has closed, Bayer will own full rights to Vividion’s proprietary discovery platform, including the chemoproteomic screening technology, an integrated data portal, and a proprietary chemistry library. Vividion, however, will operate autonomously and on an “arm’s length basis,” according to a press release from Bayer.

“This acquisition is a cornerstone of our strategy to fuel our pipeline with breakthrough innovation,” said Stefan Oelrich, a member of the Board of Management, Bayer AG and president of Bayer’s Pharmaceuticals Division, in the press release. “Vividion’s technology is the most advanced in the industry, and it has demonstrated its ability to identify drug candidates that can target challenging proteins.”

Bayer has acquired Vividion Therapeutics, a US-based biopharmaceutical company.

Bayer Acquires Vividion Therapeutics for $1.5 Billion

On Aug. 12, 2021, Rentschler Biopharma announced that it has broken ground at its new production site, adjacent to its existing Milford, Mass., site where it will build the Rentschler Biopharma Manufacturing Center US, a new facility that will add 22,000 ft

 of manufacturing cleanroom space and house four new 2000-L single-use bioreactors. The company expects the RBMC US to be operational in late 2023.

The facility is designed with upstream ballroom processing-size space for production flexibility and downstream processing suites equipped with buffer storage and preparation space. The building will be able to accommodate future expansions for scale up and capacity. The new site will also include expanded quality control, development, and warehousing capabilities and will be highly automated while leveraging industry 4.0 solutions. The facility is expected to provide innovative digital and analytical services, such as advanced analytics yield optimization, augmented/virtual reality-enabled operations, and no-touch batch releases.

The new site is expected to expand Rentschler Biopharma’s ability to offer the US market commercial capacity and project diversity. Similarly, the current Milford site has undergone expansion, going from a single-product commercial facility to a multi-product-producing facility in scales up to 500 L. The new facility will add space for manufacturing and will enable the company to centralize its support services for US projects.

“With Rentschler Biopharma’s contribution to the production of mRNA [messenger RNA] vaccines to beat the COVID-19 virus, we have seen firsthand how important it is to have highly adaptable capacity and to have the experience and expertise needed to produce new therapeutic modalities fast. The US expansion we have kicked off at the groundbreaking is part of our ongoing plan to strategically grow our business as we support our clients in developing and manufacturing even highly complex molecules,” said Frank Mathias, CEO of Rentschler Biopharma SE, in a company press release.

“This new site will double our commercial [C]GMP [current good manufacturing practice] manufacturing capacity. By bringing in state-of-the-art technology and industry 4.0 solutions, RBMC US will strongly enhance our value proposition in commercial manufacturing,” said Martin Kessler, CEO of Rentschler Biopharma Inc., the company’s wholly owned US subsidiary, in the press release.

Rentschler Biopharma has broken ground nearby its Milford, Mass., site where it will build its new multi-product manufacturing facility for commercial production of complex molecules. 