How have lessons from the pandemic influenced the way companies use technology to perform quality-control procedures?

A New View on Quality Control?

Preclinical and clinical research is improving ADC development.

ADC Development Improves on Research

Strategizing drug development in the preclinical phase has merit.

Preclinical Strategies Benefit Biopharma Development

Perfusion cell culture gains advantage with PAT tools advancement.

Perfusion Cell Culture is Gaining Momentum

Coating is an alternative to silicone oil as a lubricant. URL for article 

Syringe Coating Technology

Redefining Contamination Control for CGTs

Novavax COVID-19 Vaccine Receives EUA in Indonesia

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

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.

Articles

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

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

Editor of Pharmaceutical Technology Europe

Globally, the biopharmaceuticals market has been experiencing growth and is expected to continue its upwards trajectory in the near future. According to market research, the global biopharmaceuticals market is forecast to grow at a compound annual rate of 7.32% between 2021 and 2026 (1). Drivers for the swell in biopharmaceuticals include the rising aging population, increase in the prevalence of chronic diseases, and expanding acceptance of the complex molecular drugs as treatments for diseases that were previously untreatable (1).

A subset of the biopharmaceutical market is advanced therapeutic medicinal products (ATMPs) or cell and gene therapies (CGT). These regenerative medicines have the potential to provide patients with curative treatments for a host of diseases and, as such, have been piquing the interest of big players in the industry for some years now, which is apparent through the influx in M&A activity and investment in the space (2).

According to the International Society for Cell & Gene Therapy (ISCT), whose expertise lies in the translation of CGTs, the science surrounding CGTs is currently advancing faster than can be feasibly translated through to regulatory approval of therapies. And, in general, clinical trials are being performed with shorter-than-ideal follow-up intervals and smaller-than-ideal trial participants. However, there continues to be an influx of investment in regenerative medicine due to the success of chimeric antigen receptor (CAR) T-cell and recent gene therapy approvals, ISCT specifies.

As an example of a challenge in translating scientific innovation, Massimiliano Gnecchi, MD, PhD, ISCT regional vice-president, Europe, notes the struggles that are being experienced in Europe. Despite being home to 16 of the top 50 global life sciences universities, a leader in CGT research, and a region from which there were 120,000 CGT papers between 2017 and 2019, Europe has only accounted for 16% of the total CGT patent registrations up until 2018, Gnecchi stresses. This percentage can be compared with 56% and 28% registrations in China and the United States, respectively, even though these countries had less prominence in research papers.

One of the reasons for the performance gap between Europe and other areas can be attributed to a lack of investment, explains Gnecchi. “In 2018, the known value of US biotech deals reached $85.9 billion, some five times higher than the value of European deals, which reached $16.3 billion,” he says (3).

Another reason for the performance gap is a lack of funding in translational medicine, Gnecchi continues. “US government funds go a long way to plugging this funding gap through the Clinical and Translational Sciences Awards Program, which has a budget of more than $550 million a year for translational medicine,” he reveals. “European funding pales in comparison. As part of the Horizon Europe program, the European Union will invest about €7 billion (US$8.21 billion) in all health research between 2021 and 2027, but only a fraction of that will go into translational medicine.”

Furthermore, the European region must contend with a fragmented market and variances in regulations across the European Union member states, Gnecchi confirms. “Though unmet need might be higher than in the US, it is much harder to address at scale given different market regulations in different European countries,” he says.

Asia is being heralded as one of the fastest growing CGT markets; however, ISCT stresses that there are widely varying opinions about the size of growth in that region. For example, one report forecasts that the total Asian CGT market will grow from US$3.3 billion in 2018 to US$72.2 billion in 2030 (4), while another report has predicted a much more modest growth, with the Asia Pacific cell therapy market reaching US$2.9 billion in 2028 (5).

Essentially, the sector is burgeoning and trying to find a suitably comfortable state of equilibrium between scientific advancements and commercial viability. “We are trying to balance the excitement of having new ways to make a permanent and definitive difference to many serious diseases, how to evaluate, value, and pay for [ATMPs], and then make [ATMPs] available in an equitable manner,” adds Sven Kili, MBChB, MRCS (Eng), co-chair, ISCT Business Models and Investment Subcommittee.

The rapid scientific advancements—as a result of the imagination of scientists and clinicians in their mission to seek new and unusual ways of treating diseases, and a willingness of patients to try new approaches to treatment in combination with an increased ability to manufacture advanced therapies—are driving the market forward. The combination of these factors has led to significant record-breaking investment (6) and suggests that the growth driving CGT advancement will push the broader biopharma market forward as well, ISCT states.

However, the high costs of goods required for CGTs, directly impacts the cost of the therapies—with CGTs remaining as some of the most expensive therapies available. Unless an accepted and effective cost/value mechanism is taken up by health technology assessment organizations, such as the National Institute for Health and Care Excellence and the Institute for Clinical and Economic Review, adoption of CGTs may be limited, ISCT highlights. To be able to broaden out applications from those that are niche to widespread adoption of CGTs, it is important that manufacturing and cost of goods issues are optimized, while excellent and persuasive clinical efficacy are proven at the same time, ISCT reveals.

The biopharma market is not insulated from the new and innovative challenges companies are facing today, including cybersecurity issues, ISCT continues. Life sciences companies are increasingly susceptible to cyber-attacks on valuable intellectual property, digital assets, and sensitive medical data. Healthcare companies have consistently been rated as the lowest performers in protecting against cybersecurity risks as many of them rely on out-of-date legacy systems and have only recently started investing in this area.

For ISCT, it is vital that scientific and commercial growth are promoted to ensure the whole sector can prosper. When looking at scientific advancement around the world, government investment has played a major role, ISCT explains.

For example, in the United Kingdom (UK), the government has invested in innovation hubs (Cell and Gene Therapy Catapult), and there has been a massive boom in China due to state investment in new technologies. Additionally, in the US, the National Science Foundation has funded the Engineering Research Center CMaT (Cell Manufacturing Technologies), which is a consortium of universities, industry, and non-profits engaged in the development and translation of cell therapies along with workforce education and training for the sector, ISCT asserts.

ISCT adds that the Australian Federal Government has established an AUS$500 million Biomedical Translation Fund (BTF) with AUS$250 million of government capital and AUS$250 million private sector capital to be used to invest in biomedical discoveries, particularly targeting projects at advanced pre-clinical and Phase I and II stages of development. The BTF is intended to complement the Medical Research Future Fund (MRFF), which is currently valued at AUS$20 billion.

Sector growth is often commercially tied to fast growing economies as these, combined with mature regulatory environments, provide the conditions necessary for extensive expansion, ISCT states. Focusing on Asia, Japan ranks as the most active in market approval of new CGTs after the country’s regulatory reform in 2013–2014 has allowed for a proactive conditional approval of therapies. Japan is also home to big companies, such as Fujifilm and Astellas, which are investing a lot of money in CGTs and appropriate manufacturing technologies, ISCT specifies.

Korea has been a leading country in the cell therapy market having 16 approved products developed by domestic companies (7), including two immune cell therapies and four mesenchymal stem cells therapies, ISCT reports. Korea has also enacted new legislation on CGTs in August 2020 that includes the conditional and fast-track approval process and facilitates clinical research (8).

Reformations of CGT regulations have also been happening in other countries within Asia, such as China, India, Taiwan, and Singapore, ISCT continues. These reformations have provided a favorable landscape for market approvals of CGTs with new products expected to be available soon, ISCT stresses.

The cost of goods will be improved in the future, particularly as there is continued scale up of cell and gene therapies and the industry gains a better understanding of critical manufacturing components and quality attributes, which can lead to manufacturing products in a more scalable and automated way, ISCT states. Additionally, the rate of innovation and investment in the sector will continue to move in an upwards trajectory, fuelling exponential increase in biopharma clinical trials, especially in the areas of CGT and messenger RNA (mRNA) manufacturing, ISCT continues.

Furthermore, mRNA technology, which has been validated thanks to the success of the COVID-19 vaccination programs, will witness further development in other areas, ISCT explains. 

 gene therapy will also continue to expand.

However, industry will also continue to experience challenges and disruptions because of the pandemic, ISCT warns. Supply chain disruptions will continue and raw materials, that are required for CGT products, will still be difficult to obtain by manufacturers.

Biopharmaceuticals Market—Growth, Trends, COVID-19 Impact, and Forecasts (2021–2026

), Market Report, May 13, 2021.
2. finnCap Group, “Cell and Gene Therapy: The Future of Medicine Attracts Major M&A Activity,” Blog, Aug. 6, 2020.
3. A. Loche, et al., “A Call to Action: Opportunities and Challenges for CGTs in Europe,” 

, Article, Jan. 19, 2021.
4. Visiongain, “Visiongain Publishes Cell Therapy Technologies Market Report 2021–2031,” Press Release, March 15, 2021.
5. Research and Markets, 

Asia Pacific Cell Therapy Market Size, Share, and Trends Analysis Report by Use-Type (Clinical-Use, Research-Use), by Therapy Type (Autologous, Allogenic), and Segment Forecasts, 2021–2028

, Market Report, June 2021.
6. Alliance for Regenerative Medicine, 

Regenerative Medicine in 2021: A Year of Firsts and Records

, Report, August 2021.
7. N. Cuende, et al., 

Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, 

Felicity Thomas is the European editor for BioPharm International.

Scientific innovation and regulatory reformations are helping to drive the global biopharma market forward, but a balance between cost and value still needs to be accepted for widespread adoption.

Finding the Right Balance for Advanced Therapies

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.

Novo Nordisk Acquires Dicerna for $3.3 Billion

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

Secarna Pharmaceuticals, a Germany-based biopharmaceutical company focused on next-generation antisense oligonucleotide (ASO) therapies, announced on Nov. 10, 2021 that it has entered into a research, option, and license agreement with Achilles Therapeutics, a member of the Achilles Therapeutics plc group of companies, to optimize the development of T cell therapies in Achilles’ pipeline.

Under the agreement, Secarna will receive an undisclosed upfront payment, a target-based technology access fee, and option exercise fees. The company is also eligible to receive development and commercial milestone payments and tiered royalties on net sales of personalized T cell therapies developed and commercialized under the collaboration.

In the collaboration, Secarna will apply its discovery and development platform, LNAplus, to generate ASO candidates against selected targets. These targets potentially play a central role in the 

 optimization of personalized T cell therapies under development by Achilles. Secarna will also perform 

 testing, after which Achilles will conduct production feasibility and optimization testing.

“We are excited to collaborate with Achilles and jointly work on a highly innovative approach to optimize T cell therapies with our LNAplus-based ASOs,” said Alexander Gebauer, CEO of Secarna Pharmaceuticals, in a company press release. “By combining our industry-leading antisense oligonucleotide platform with Achilles’ expertise in the field of T cell therapies, we see the potential to break new ground in the treatment of cancer patients.”

Secarna Pharmaceuticals and Achilles Therapeutics have entered into an agreement to optimize the development of T cell therapies in Achilles’ pipeline.

Secarna Pharmaceuticals and Achilles Therapeutics Partner on T Cell Therapy Development

The Cell and Gene Therapy Catapult (CGT Catapult) and Deep Science Ventures, a London-based venture creator, have collaboratively launched a partnership to generate innovative approaches that address barriers in the advanced therapy medicinal products (ATMP) industry. The partnership’s goals are to create new companies and deliver better patient outcomes, CGT Catapult announced in a Nov. 11, 2021 press release.

Under the agreement, CGT Catapult and Deep Science Ventures will spend the next 12 months identifying an area that is ripe for innovation, hire a founding analyst to evaluate potential approaches for scientific and commercial viability, build teams around optimal approaches, and create one or more high-impact ventures. Furthermore, in addition to improving patient outcomes, the partners aim to ultimately increase job opportunities and innovation in the ATMP sector.

Major hurdles for ATMP development include the challenges of ensuring target specificity and achieving effective manufacturing at-scale. Under this collaboration Deep Science Ventures will use its outcome-focused approach to venture creation, in which it will combine available scientific knowledge with founder-type scientists into high-impact venture companies. CGT Catapult will provide its cell and gene therapy-specific technical, non-clinical, and regulatory expertise to apply Deep Science Ventures’ approach to the ATMP sector.

“Joining forces with the CGT Catapult enables us to bring our unique approach to innovation to the cell and gene therapy ecosystem. Bringing together [Deep Science Ventures’] structured approach to venture creation and the ability to tap into the [CGT] Catapult’s network of expertise will allow us to create high-impact solutions overcoming some of the barriers holding back the ATMP space,” said Kerstin Papenfuss, associate director Pharma, Deep Science Ventures in a company press release.

“The innovative and collaborative concept used by [Deep Science Ventures] fits well with the CGT Catapult’s ethos, and, by addressing challenges within the cell and gene therapy industry, our activities have the potential to provide exceptional outcomes in driving innovation forward and creating opportunities in employment. We very much look forward to initiating our work together and creating new partnerships between scientists and investors,” said Matthew Durdy, CEO of CGT Catapult, in the press release.

CGT Catapult and Deep Science Ventures have partnered to encourage innovative approaches to overcoming barriers in delivering advance therapies to patients.

CGT Catapult and Deep Science Ventures Team Up to Boost Innovation in Advanced Therapies

Chris Spivey is the editorial director of 

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part four, 

serialization from a regulatory perspective

Watch part 1: serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective 

Watch part 3: serialization from a software perspective

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront.

In this discussion, global supply chain experts examine implications of the DSCSA (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation considerations for the DSCSA approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward? 

Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?

Experts from across the global supply chain will provide insight and answers to these questions.

 is the vice president of community engagement at GS1 US. GS1 is a not-for-profit organization that develops and maintains global standards for business communication. Angela is responsible for driving broader adoption of GS1 Standards to help industries achieve their goals for improved traceability, information transparency, and data quality.

 leads the GS1 Healthcare Global Public Policy Work Team, which has the mission to interact with decision-makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector.

Watch other videos in this keynote series

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Regulatory | Part 4

GlaxoSmithKline (GSK) has been granted approval by the European Commission (EC) for its monoclonal antibody therapy, Nucala (mepolizumab), which targets interleukin-5 (IL-5) as a treatment for three additional eosinophil-driven diseases.

According to a Nov. 17, 2021 press release, the approval follows on from the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) and means that Nucala can be used as an add on treatment in hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps. The commission’s decision has been based on data from pivotal trials that have investigated the role of targeted IL-5 inhibition with mepolizumab in the three aforementioned eosinophil-driven diseases.

“With millions of patients across Europe affected by eosinophil-driven diseases, we recognize the urgency in delivering the first approved targeted treatment for use in four of these conditions,” said Hal Barron, chief scientific officer and president R&D, GSK, in the press release. “Today’s approvals reinforce the important role treatments such as mepolizumab can play in helping to improve the lives of patients with these debilitating diseases.”

“The lives of patients affected by an eosinophil-driven disease are often impacted by what can be severe or life-threatening symptoms. They may rely on both intermittent or continuous oral steroids to manage their condition or be left feeling they have no option but to endure ongoing symptoms and possible flare-ups,” added Tonya Winders, CEO & president, Allergy and Asthma Network and president of Global Allergy and Airways Patient Platform, in the press release. “The availability of mepolizumab, a targeted biologic therapy, provides patients and their healthcare professionals with a new option in their armamentarium to treat hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps.”

GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.

GSK Receives European Approval for Three Additional Indications of Nucala

The European Commission (EC) has granted marketing authorization for Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19 who do not require supplemental oxygen and who are at an increased risk of disease progression, Celltrion Group announced on Nov. 15, 2021.

EC’s decision follows on from the positive opinion that was granted by the European Medicines Agency’s Committee for Medicinal Products for Human Health (CHMP) on Nov. 11, 2021. The approval has been based upon clinical trial data from a global Phase III study involving more than 1315 participants. In the study, it was demonstrated that regdanvimab, a monoclonal antibody therapy, significantly reduced the risk of COVID-19 related hospitalizations or death in high-risk patients.

“Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day. As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia, and [Latin America]. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments.”

EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.