Early investment in formulation strategies will maximize the chance of success.

The Earlier the Better in Formulation

Advances in simulation and the development of digital twins.

Computational Fluid Dynamics in Upstream Biopharma Manufacturing

Different methods give different answers when calculating limits for impurities.

Detecting and Determining Quantitation Limits for Impurities

Automatic visual inspection machines and AI highlight inspection deficits.

Visual Inspection: Seeing Room for Improvement?

Despite their promise, alternative drug delivery approaches are complex and must be justified.

Taking an Alternative Approach to Drug Delivery

Traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data. 

Practical SPC Rules to Apply on Pharmaceutical Process Data

Novavax COVID-19 Vaccine Receives EUA in Indonesia

FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children

AstraZeneca has unveiled a new £1 billion (US$1.33 billion) facility in Cambridge, United Kingdom, that has been designed to high environmental standards and with the space to accommodate 2200 research scientists. The formal unveiling took place in the presence of His Royal Highness The Prince of Wales.

According to a Nov. 23, 2021 press release, the new facility, The Discovery Centre (DISC) includes advanced robotics, high-throughput screening, and artificial intelligence (AI)-driven technology. Additionally, it was specified that DISC will be used to support AstraZeneca’s focus on precision and specialized medicines while also fostering collaboration for the discovery and development of next generation therapeutics, such as nucleotide-based, gene-editing, and cell therapies.

“Our ambition […] is to not only unveil a building, but to also drive the next wave of scientific innovation,” said Pascal Soriot, CEO, AstraZeneca, in the company press release. “Our new Discovery Centre in Cambridge raises the bar for sustainable R&D and global collaboration across our industry. It will allow us to break new boundaries in the understanding of disease biology, bring life-changing medicines to patients and power the next stage of our company’s growth.”

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AstraZeneca has unveiled its new facility, The Discovery Centre, which will be used to support the company's focus on precision and specialized medicines, and to foster industry collaboration.

AstraZeneca Unveils State-of-the-Art R&D Facility in Cambridge

Life science company Eppendorf has donated €20,000 (US$22,400) to the European Molecular Biology Laboratory (EMBL) to support the “Advancement of Women in Science” project, it was revealed in a Nov. 22, 2021 press release.

EMBL’s project is aimed at enabling women scientists to begin managerial careers in scientific fields. Eppendorf’s donation, which reinforces the corporate partnership between the company and EMBL, will allow 20 women postdocs to join the program for women scientists in managerial positions.

“To offset this disparity [between the genders in managerial positions in the scientific community], the EMBL took action in 2020 and initiated a program called ‘Leadership and Excellence for Aspiring Women Postdocs’ (LEAP) that includes a one-year mentoring and coaching program,” said Edith Heard, director general of EMBL, in the press release. “This generous donation from Eppendorf will enable 20 additional female postdocs to gain the qualifications they need for managerial careers. We hope that they go on to become group leaders, leading researchers and assistant professors in scientific fields.”

“Solidarity, tolerance, and diversity are the defining features of the cosmopolitan culture that Eppendorf fosters and the foundation of the company’s success,” added Eva van Pelt, Co-CEO of Eppendorf SE, in the press release. “The disparity between the number of men and women who hold managerial positions in the scientific community is a serious problem. Increasing the visibility of women in science is both a declared goal and an important concern at Eppendorf.”

Eppendorf has donated €20,000 (US$22,400) to the European Molecular Biology Laboratory (EMBL) in support of the “Advancement of Women in Science” project.

Eppendorf Makes Donation to Support Women Working in Science

The European Commission (EC) has granted marketing authorization for Gilead’s Trodelvy (sacituzumab govitecan) to be used as a monotherapy to treat adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have already received two or more systemic therapies, with at least one of those for advanced disease. Gilead announced the positive outcome from the EC in a Nov. 23, 2021 press release.

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate, which has been specifically directed to the Trop-2 receptor—a protein that is overexpressed in numerous types of epithelial tumors. The commission’s decision was based upon Phase III trial data, demonstrating the efficacy of Trodelvy in reducing the risk of death and improving survival in TNBC patients.

“The metastatic stage of TNBC is particularly challenging to treat and until now we have urgently needed new treatment options for people in Europe living with this condition,” said Véronique Diéras, senior medical oncologist head, Breast Cancer Group, Department of Medical Oncology, Centre Eugène Marquis, Rennes, France, in a company press release. “Today’s approval including second-line metastatic TNBC is significant for the community as it’s another important step forward in helping women with this disease live longer.”

“At Gilead, we push boundaries to deliver transformative science and novel treatment options that address urgent medical needs,” said Merdad Parsey, chief medical officer, Gilead Sciences. “We understand how difficult metastatic TNBC is to treat and we’re proud that Trodelvy can now offer a second-line treatment option with the potential to bring longer life to people living with this aggressive disease.”

The EC has granted marketing authorization for Gilead’s Trodelvy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.

EC Grants Marketing Authorization to Gilead’s Trodelvy

MilliporeSigma announced the launch of its new ColorWheel flow cytometry portfolio on Nov. 16, 2021. The ColorWheel uses technology optimized for flow cytometry that allows users to select antibodies and dyes for assembly in any desired combination, resulting in an output of mix-and-match antibodies and dyes analogous to a primary conjugated antibody.

According to a company press release, multiplexing in flow cytometry can be difficult because researchers must consider instrument configuration, antigen expression and dye brightness balance, and antibody–dye combination availability. In this regard, the ColorWheel is designed to overcome these constraints by making it easier to build a new multiplex assay for samples with varying expression levels of antigen.

According to the press release, the ColorWheel:

Has the flexibility to pair any antibody with any dye in a ready-to-use, convenient format

Can be used in five minutes of hands-on time, minimizing necessary time and effort

Uses a preservative-free presentation that promotes sustainability and wider sample type compatibility

Delivers a lyophilized product, enhancing stability and allowing for ambient shipping.

MilliporeSigma’s new ColorWheel flow cytometry portfolio is designed to create antibodies and dyes analogous to a primary conjugated antibody.

MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio

Denali Therapeutics announced on Nov. 17, 2021, that its strategic partner Takeda Pharmaceutical Company has exercised an option, pursuant to an existing collaboration agreement between the two companies, to co-develop and co-commercialize DNL593 (PTV:PGRN), an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin (FTD-GRN).

Denali and Takeda entered into a collaboration agreement in January 2018. Takeda was granted an option for three programs, including PTV:PGRN. Exercising its option, Takeda now obtains the right to develop and commercialize DNL593 jointly with Denali. The companies will share the development and commercialization costs equally, and, if applicable, profits on a worldwide basis.

“We are excited to advance our collaboration with Takeda on the development of DNL593 as a potential treatment for people with FTD-GRN,” said Ryan Watts, PhD, CEO of Denali. “Pending acceptance of regulatory submissions, DNL593 will be the sixth therapeutic candidate from our broad pipeline, and our second Transport Vehicle (TV)-enabled molecule, in clinical development. This progress underscores the potential of our TV platform technology, which is designed to enable and enhance [the] delivery of biologic therapeutics to the brain for the treatment of neurodegenerative diseases.”

Takeda has exercised an option to co-develop and co-commercialize an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin.

Denali Therapeutics and Takeda to Jointly Develop and Commercialize Investigational Treatment for FTD-GRN

In a Nov. 17, 2021, press release, GlaxoSmithKline (GSK) and Vir Biotechnology announced United States government contracts totaling approximately $1 billion to purchase sotrovimab, an investigational monoclonal antibody (mAb) for the early treatment of COVID-19. FDA granted sotrovimab an Emergency Use Authorization (EUA) in May 2021. GSK will supply doses of sotrovimab to the US government by Dec. 17, 2021, to expand nationwide access to sotrovimab for patients.

In addition, the US government will have the option to purchase additional doses through March 2022. The total number of sotrovimab doses secured through binding agreements—including the contracts with the US government—is now more than 750,000 doses globally. This includes the previously announced joint procurement agreement with the European Commission.

Sotrovimab is an FDA EUA authorized investigational single-dose intravenous (IV) infusion SARS-CoV-2 mAb. Under the EUA, sotrovimab can be used as a treatment for mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older and weighing more than 88 pounds). These patients must have positive test results for COVID-19 and be at high risk for progression to severe COVID-19, including hospitalization or death.

The Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response through the Department of Defense, funded the US government purchase.

United States government contracts total approximately $1 billion to purchase sotrovimab, an investigational mAb. 

US Government to Pay $1 Billion for GSK and Vir Biotechnology’s Early Treatment of COVID-19

A new report from CRB looks at how stakeholders in the biopharma value chain are navigating the disruption to business models caused by the pandemic and rising demand for ever-faster delivery of critical treatments, the company said in a Nov. 16. 2021 press release announcing the report’s availability. The 

 report combines a survey of biopharmaceutical industry leaders with analysis from CRB’s life sciences subject matter experts. Topics reviewed include project delivery, increasingly complex pipelines, digitalization, and other important topics.

According to the press release, one of the topics discussed in the report is the idea of “warp speed delivery.” Speed to market is a more significant business driver at the same time that companies face significant delays in their capital planning strategies, CRB reports. There is a push to Pharma 4.0, and companies aspire to operate digitally integrated facilities with predictive, real-time analytics within the next one to two years, reported CRB. Companies are moving away from traditional design-bid-build methods for large capital projects and are using artificial intelligence tools.

In cell and gene therapy, nearly half of the survey respondents reported plans to move away from autologous cell therapies to focus on modalities with fewer challenges, CRB reported. Viral vector gene technologies will continue to be used in the near term to produce genetically modified cell therapies to ensure quality and reduce operational costs. CRB reports that the survey indicates growing interest in RNA-based therapies and in oligonucleotides.

“Taming the disruption will require a whole new mindset, which casts off our industry’s conservative nature in favor of more innovation, more speed, and more flexibility in the name of more lives saved,” said Noel Maestre, CRB’s vice-president of Life Sciences, in the report.

Speed to market, flexibility, and digitalization are important topics in biopharmaceutical manufacturing.

CRB Report Investigates Pharma Facility Trends

Launched in November 2021, Sartorius’ newly redesigned Sartolab RF|BT 150–1000 vacuum filtration units offer faster and higher capacity filtration while allowing for enhanced physical stability for a wide range of sample types. The modifications to the product’s design include:

Increased membrane surface area to facilitate optimal filtration

A new 0.45 µm polyethersulfone membrane in place of the 0.45 µm cellulose acetate membrane to increase flow rate while keeping the same low-protein binding properties

An optimized center of gravity to increase stability of the units

Able to be directly used on the Sartolab Multistation for parallel filtration

In addition, the new vacuum filtration units are available in three different pore sizes to meet the needs of most applications, as follows:

0.22 µm for sterile filtration of cell culture media, buffers, and reagents

0.45 µm for clarification of aqueous and viscous solutions

“We are excited to introduce our updated Sartolab vacuum filtration units, which build upon the benefits and ergonomic design of the original units,” said Catherine Leluan, product manager, Sartorius, in a Nov. 1, 2021 press release. “The redesign of these units exemplifies our commitment to engineer products that accelerate and streamline workflows, are user-friendly and are well-suited for the busy laboratory setting. In addition, improvement in our manufacturing controls [is] expected to lead to increased robustness of supply to help meet growing market demand.”

Sartorius’ newly redesigned vacuum filtration units are designed to allow for faster and higher-capacity filtration while offering enhanced stability for sample processing.

Sartorius Offers Redesigned Vacuum Filtration Units with Higher Capacity and Faster Speed

FDA announced in a Nov. 19, 2021, press release that it has officially amended its Emergency Use Authorization (EUA) for both Pfizer-BioNTech’s and Moderna’s COVID-19 single-shot booster vaccinations to now include all adults. To qualify, individuals must be 18 or older and be at least six months removed from completion of their primary vaccination series of the Pfizer-BioNTech or Moderna shots. If they received the Janssen single-shot vaccine, this limit is reduced to two months.

Prior to this announcement, booster vaccinations were only made available to individuals aged 65 or older, individuals aged 18 through 64 at high risk of severe COVID-19, and individuals aged 18 through 64 with frequent institutional or occupational exposure to SARS-CoV-2.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” said Janet Woodcock, acting FDA commissioner, in an agency press release. “Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death.”

According to the release, this decision was made following an evaluation of immunity data from clinical trials of both the Pfizer-BioNTech and Moderna vaccines. The Pfizer-BioNTech trial evaluated 200 participants aged 18 through 55 who received a single booster dose at least six months after their second dose relative to peers who only completed the two-dose series, while the Moderna trial did a similar evaluation of 149 individuals aged 18 or older. Both studies found an increased immune response in the booster group one month after vaccination.

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the press release. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

FDA Authorizes COVID-19 Boosters for All Adults

Novo Nordisk announced that it would acquire Dicerna, a biopharmaceutical company focusing on ribonucleic acid interference (RNAi) technology, for approximately $3.3 billion on Nov. 18, 2021. This blockbuster deal will give Novo Nordisk rights to Dicerna’s GalXC RNAi platform, which is designed to enable access to intracellular disease targets across hepatic and extrahepatic cell and tissue types.

Novo Nordisk and Dicerna entered into a research collaboration in 2019 to develop RNAi therapies via GalXC. The companies explored more than 30 liver cell targets with the potential to deliver clinical candidates for conditions like chronic liver disease, nonalcoholic steatohepatitis, type 2 diabetes, obesity, and various rare diseases. Novo Nordisk expects to initiate clinical development of the first investigational RNAi therapeutic born from this collaboration in 2022.

According to a Dicerna press release, RNAi is a disease inhibition technology that works by silencing genes via specific destruction of the messenger RNA (mRNA) made from the gene. Rather than inhibiting the protein, this is intended to prevent its creation. GalXC technology uses a proprietary N-acetyl-D-galactosamine (GalNAc)-mediated structure of double-stranded RNA molecules designed to bind specifically to receptors on liver cells. This is designed to lead to selective hepatocyte internalization and permit access to the RNAi machinery within the cells.

“The acquisition of Dicerna accelerates Novo Nordisk’s research within RNAi and expands the usage of the RNAi technology,” said Marcus Schindler, executive VP and chief scientific officer of Novo Nordisk, in the press release. “We build on our successful collaboration and by combining Dicerna’s state-of-the-art RNAi drug engine and intracellular delivery with our deep capabilities in disease biology understanding and tissue targeting through peptides and proteins, we have the potential to expand our pipeline and deliver life-changing precision medicines for people living with chronic diseases such as diabetes, obesity, cardiovascular disease and NASH, as well as rare diseases like endocrine disorders and bleeding disorders.”

“Since the start of our collaboration two years ago, the Dicerna and Novo Nordisk teams have established a strong rapport built on a foundation of mutual respect for one another’s capabilities, culture, and expertise,” said Douglas Fambrough, founder, president, and CEO of Dicerna, in the press release. “The combination of Dicerna’s expertise in RNAi and oligonucleotide therapeutics and highly skilled employees with Novo Nordisk’s industry leadership in developing and commercializing medicines to treat serious chronic diseases, has the potential to significantly accelerate and expand our mission to deliver GalXC RNAi therapies for the benefit of patients and all our stakeholders.”

Novo Nordisk’s 3.3 billion acquisition of Dicerna gives them access to their RNAi technology.