Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

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Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

MilliporeSigma Mobius ADC Reactor| © MilliporeSigma

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, introduced the Mobius ADC Reactor, a single-use reactor designed specifically for the manufacture of antibody drug conjugates (ADCs). The reactor is the first of its kind for ADC production, according to the company. The Mobius ADC Reactor is designed to meet the unique requirements for linking the necessary components for ADCs and aims to enable these critical therapies to be produced faster and more safely with faster turnaround times and fewer cross-contamination risks. Performance improvements using the single-use reactor include elimination of potent liquid waste and a 70% increase in efficiency. The reactor’s single-use assemblies are made of Ultimus Film technology, which provides enhanced bag strength, improved durability, and leak resistance.

Articles

The Mobius ADC Reactor is the first single-use reactor designed specifically for the manufacture of antibody drug conjugates.

Single-use ADC Reactor

CPC MicroCNX ULT Series aseptic microconnector | © CPC

The MicroCNX ULT Series from Colder Products Company (CPC) is the first aseptic micro-connector that can be fitted directly into freeze cassettes used in cell and gene therapy (CGT) processing. It can be frozen to -190 °C. It is compatible with the most common types of tubing, including polyvinyl chloride (PVC), used in developing advanced therapies. The connectors are compact enough to fit into a freeze cassette and can be frozen with vaporized liquid nitrogen. They are designed to provide a simple, efficient method of sterile connection of tubing used for small CGT assemblies. They also eliminate the need for adding extra tubing into the process, thus helping to reduce the amount of product hold-up or product loss. The MicroCNX ULT series termination and flow path are constructed from polyphenylsulfone, a high-performance polymer that is chemically compatible with the harsh chemicals, such as dimethyl sulfoxide, used in cryopreservation processes. This new series adds to CPC’s 1/8” MicroCNX Series Connectors, an alternative to tube welding in creating closed sterile connections at small volumes. Similar to earlier MicroCNX products, the MicroCNX ULT series features a 1/8” flow path and offers options for 1/8”, 3/32”, and 1/16” hose barb terminations to support a variety of tubing sizes and materials, such as PVC, silicone, and thermoplastic elastomer.

CPC’s MicroCNX ULT Series represents the first aseptic microconnector that can be fitted directly into freeze cassettes for GCT production.

Aseptic Micro-Connector

In this episode of Drug Digest, industry experts discuss the ongoing development of automating biomanufacturing processes, including its challenges and practical applications. 

From Theory to Reality: Automating Process Development

The biopharmaceutical industry has seen the use of automated technologies in biomanufacturing processes grow over the years from theory to reality. In this episode of 

, industry experts discuss the ongoing advancement of automation in the biopharmaceutical industry. They give insight into how automated technologies are put to use today and how they are streamlining process development, with an eye toward saving cost, time, and manufacturing footprint.

John Hatzis, Global Life Sciences Industry Consultant, Rockwell Automation

John Hatzis has been with Rockwell Automation for ten years where he has leveraged his expertise using Rockwell technology in a variety of applications in the Life Sciences industry. He works with BiofabUSA consulting on control systems for new tissue therapies. John has a BSc in Chemical Engineering from Worcester Polytechnic Institute.


Smriti Khera, Global Head of Life Sciences Strategy and Marketing, Rockwell Automation

Smriti Khera is the global head of Life Sciences Strategy and Marketing at Rockwell Automation. She holds a PhD in Pharmaceutical Sciences from the University of Arizona, where her focus was drug discovery from natural products. After working as a pharma research scientist, she pivoted to strategic marketing to increase her impact. Over the past 12 years she has held strategy and marketing leadership roles with increasing levels of responsibilities at both Fortune 500 and early stage startups. She is passionate about leveraging her unique expertise to generate sustained impact across healthcare and life sciences using automation and digital technologies.

This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Solid Dosage Drug Development and Manufacturing

Videos

Drug Digest: From Theory to Reality: Automating Process Development

Feliza Mirasol is the science editor for 

Gefion, a new artificial intelligence (AI) supercomputer built on an AI data center infrastructure known as NVIDIA DGX SuperPOD (1), is now operational in Copenhagen, Denmark, the Novo Nordisk Foundation announced on Oct. 23, 2024. The supercomputer was launched at an event in Copenhagen, where it was symbolically “turned on” by His Majesty King Frederik X of Denmark; Jensen Huang, founder and CEO of NVIDIA, a US-based supercomputing company; and Nadia Carlsten, CEO of the Danish Centre for AI Innovation (DCAI).

Following its launch, Gefion is being readied for customers, beginning with a pilot phase in which select customers interested in using AI will use it to accelerate innovation in many areas, from quantum computing to drug discovery to societal challenges, such as the transition to green energy.

“Gefion provides our Danish enterprises with entirely new opportunities,” said Morten Bødskov, the Minister for Industry, Business, and Financial Affairs, Denmark, in a press release. “Gefion will drive the advancement of the green transition, enable tailor-made solutions, and strengthen the competitive standing of our companies in the global market. In a time of heightened international competition, this supercomputer acts as a vital enabler for advancing Danish businesses into the future. This ground-breaking technology represents an important opportunity for Danish companies and researchers to develop innovative solutions to future challenges.”

A public–private partnership between the Novo Nordisk Foundation and the Export and Investment Fund of Denmark (EIFO) resulted in the establishment of the new supercomputer. This partnership funded and established DCAI, a new company that owns and will operate Gefion.

“It’s a remarkable achievement that it has taken only six months from announcement to completion of this complex state-of-the-art supercomputer,” said Carlsten. “I am extremely proud of the team that came together and collaborated to turn this vision into a reality, delivering a leading capability that is now ready for customers to start testing new use cases. Gefion is the game-changer that many innovators had been waiting for.”

Huang added in the release, “Denmark recognizes that to innovate in AI, the most impactful technology of our time, it must foster a domestic AI infrastructure and ecosystem. The Gefion supercomputer will supercharge the scientists of Denmark with local AI computing infrastructure to drive advancements in life sciences, climate research, and quantum computing.”

Gefion is powered by 1,528 graphic processing units (GPUs) (NVIDIA H100 Tensor Core GPUs) and is interconnected using networking (NVIDIA Quantum-2 InfiniBand). According to the press release, “Denmark up to now had no GPU-accelerated supercomputers, and a thorough consulting process with relevant stakeholders across the country had identified access to computing power as a key roadblock to progress in Denmark’s otherwise thriving AI-based research ecosystem.”

Digital Realty, a global data center provider, hosts the supercomputer in an AI-ready data center facility in Denmark, which is designed and built sustainably, running on 100% renewable energy, according to the press release. Gefion was assembled and installed by Eviden, a European-based high-performance computing company.

In addition to the Novo Nordisk Foundation’s funding, EIFO contributed DKK 100 million (US$15 million) and owns a 15% minority stake in DCAI.

“Establishing Gefion is a milestone, and it fits very well with the Novo Nordisk Foundation’s vision of improving people’s health and the sustainability of society and the planet, as it creates new opportunities and can accelerate finding new solutions to pressing challenges,” said Mads Krogsgaard Thomsen, CEO of the Novo Nordisk Foundation, in the release. “In the future, we must cooperate even more with exceptional partners from all over the world if we are to solve the enormous challenges facing not only our own countries but the planet.”

Researchers will have the opportunity to engage with expert teams from NVIDIA in selected flagship project areas to co-develop solutions to complex problems. These areas include pharmaceuticals and biotechnology research, accelerating the green transition; and developing fault-tolerant (i.e., error-free) quantum computing using an open-source hybrid quantum computing platform (NVIDIA CUDA-Q).

With DKK 600 million (US$87.4 million) in funding from the Novo Nordisk Foundation, the new supercomputer offers the potential to accelerate innovation in drug discovery.

Denmark’s First AI Supercomputer for Drug Discovery Now Operational Under Novo Nordisk Foundation Commitment

Sartorius Vivaflow SU cassette | © Sartorius

Sartorius’ Vivaflow SU tangential flow filtration (TFF) is designed to be more user-friendly and to allow for more flexibility in laboratory workflows. The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes in the range of 100 mL–1000 mL. Vivaflow SU is an all-in-one cassette, which reduces cost and complexity and streamlines workflows for molecule isolation. Each cassette is ready to use and has a standard laboratory pump for simple set-up, which avoids the need for expensive systems and expensive process optimization. It also allows for faster and more reliable concentration and rebuffering of any molecule. The cassette eliminates the need for cleaning and reduces contamination risk while minimizing waste. Sustainability features include a new housing that uses 30.5% less plastic. It also incorporates several eco-friendly design improvements, such as locally sourced raw materials, customized tubing kits for each cassette configuration, a digital user manual, and reduced non-recyclable packaging; all of which are meant to contribute to a lower research footprint. Vivaflow SU is the-next-generation TFF cassette that replaces the previous Vivaflow 50 model. It is applicable for research scientists who require a fast and reliable means for concentrating and rebuffering large feed volumes in molecule isolation workflows.

The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes of 100 mL–1000 mL.

Tangential Flow Filtration Cassette

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending Wainzua (eplontersen) for treatment of hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or 2 polyneuropathy (PN) in England and Wales, AstraZeneca announced in a press release on Oct. 29, 2024 (1).

“We are delighted that eligible patients now have access to this treatment for this significant disease which can be delivered in-clinic or in their own home to support more personalized care,” Tom Keith-Roach, president of AstraZeneca in the United Kingdom, said in the press release (1).

This recommendation of Wainzua closely followed that of the Committee for Medicinal Products for Human Use (CHMP) of the European Union for approval by the European Commission, 

announced by AstraZeneca on Oct. 21, 2024

 and 10 months after FDA approved eplontersen under the brand name Wainua for treatment of adults in the United States in December 2023 (2,3).

"ATTR amyloidosis is a serious, rare disease where people experience neuropathy symptoms, such as pain, discomfort, progressive weakness, and loss of sensation in the legs and arms, and mobility difficulties,” Paul Pozzo, chairman of Amyloidosis UK, said in the Oct. 29 press release. “There is no cure for ATTR amyloidosis, but today’s announcement offers an alternative treatment option to support those living with this condition in the UK ATTR community."

As with CHMP’s recommendation, NICE made its decision based on a 66-week Phase III trial (NEURO-TTRansform) (1).

“Eplontersen provides a new, disease-modifying treatment option, and this is positive news for eligible patients with ATTR-PN and the wider amyloidosis community in the UK,” Marianna Fontana, a professor of cardiology and honorary consultant cardiologist of the National Amyloidosis Centre, Division of Medicine, University College London, said in the press release. “Without treatment, ATTR-PN can lead to extreme polyneuropathy, severe disability, and premature death. In the NEURO-TTRansform Phase III clinical trial, eplontersen significantly lowered serum transthyretin concentration, resulting in less neuropathic impairment and an improved quality of life for patients.”

ATTR-PN, according to AstraZeneca, is caused by a mutation in the transthyretin (TTR) gene responsible for TTR production in the liver (1). The mutation causes the TTR protein to misfold, leading to amyloid fibril accumulation, in turn damaging peripheral nerves in the body. AstraZeneca said ATTR-PN is “frequently under-recognized” because its clinical manifestations are frequently heterogeneous and non-specific (1).

Left untreated, the severe polyneuropathy and motor disability that develops within five years of the onset of ATTR-PN can result in death within a decade (1).

1. AstraZeneca. AstraZeneca Secures Accelerated NICE Recommendation for Wainzua (eplontersen) in England and Wales Following MHRA License to Treat Hereditary Transthyretin Amyloidosis in Adult Patients with Stage 1 or 2 Polyneuropathy. Press Release. Oct. 29, 2024.
2. AstraZeneca. Wainzua (eplontersen) Recommended for Approval in the EU by CHMP for the Treatment of Adult Patients with Polyneuropathy Associated with Hereditary Transthyretin-Mediated Amyloidosis. Press Release. Oct. 21, 2024.
3. AstraZeneca. Wainua (eplontersen) Granted First-Ever Regulatory Approval in the US for the Treatment of Adults with Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis. Press Release. Dec. 21, 2023.

The treatment for ATTR in certain adults with polyneuropathy had just been recommended for approval across the European Union and had gained regulatory approval in the United States at the end of 2023.

AstraZeneca’s Wainzua Gains Another Approval in England and Wales

The Belgium-based contract development and manufacturing organization (CDMO) Ardena announced on Oct. 29, 2024 that it was making a “strategic investment” in two sites in the Netherlands, one of the countries in which the company maintains good manufacturing practice (GMP) facilities, along with Belgium, Spain, and Sweden (1). Ardena said the improvements were being made with an eye toward client demand for cutting-edge services in the field of bioanalytics.

Namely, the expansion of Ardena’s footprint in the Netherlands will include a brand-new bioanalytical laboratory at its Pivot Park facility, located in the city of Oss, as well as added capacity and new, good laboratory practice (GLP) capabilities at its Bioanalytical Center of Excellence in Assen, according to a press release (1). The enhancements in the two locations are meant to complement each other, the company said.

“This expansion allows us to quickly scale our operations, leverage an additional pool of talented professionals, and bring enhanced efficiency and value to our clients, from discovery to late-stage clinical phases,” Jeremie Trochu, Ardena CEO, said in the press release.

Ardena previously expanded its headquarters in Gent, Belgium, in 2018, at which point the company was operating in that country as well as the Netherlands, Sweden, and Latvia (2). At the time, Ardena said it was seeing an increase in organic growth of more than 20% per year, crediting its merger and acquisition strategy. Shifting forward to 2024, that strategy has most recently included the company acquiring an advanced drug product manufacturing facility in the United States from Catalent (1).

There was also, in 2021, the acquisition of Idifarma, a manufacturer of niche and highly potent generic and innovative drugs based in Pamplona, Spain, from Suanfarma (3). Ardena said its offerings are designed to serve clients from small innovators in the biotech realm to large pharma companies across all stages of drug development, and with respect to small molecules, therapeutic peptides and proteins, antibodies and antibody-drug conjugates, nanoparticles, oligonucleotides, messenger RNA (mRNA), and cell and gene therapies (1).

“Together, these investments demonstrate Ardena's focus on growth and innovation, reinforcing our strategy to assist clients navigate through an ever-increasing complex drug development process and bring life-changing therapies to patients worldwide faster,” Trochu said in the Oct. 29 press release.

The Oss laboratory, which Ardena said will be functional by the first quarter of 2025, covers 3000 sq ft for both small and large molecule analytical testing, complete with an automated technology platform, fluorometric detection assays, and liquid chromatography—tandem mass spectrometry (LC–MS/MS) capabilities (1). By contrast, although the Assen facility will also have its LC–MS/MS capacity increased and will add new automation systems, its focus will be more on immunochemistry, flow cytometry, and quantitative polymerase chain reaction platforms, according to Ardena.

1. Ardena. Ardena Expands Bioanalytical Services in Europe. Press Release. Oct. 29, 2024.
2. Ardena. Ardena Cements Growth and Expansion with New HQ. Press Release. Nov. 8, 2018.
3. Ardena. Ardena Acquires Idifarma from Suanfarma. Press Release. Sept. 1, 2021.

A new laboratory will be built in Oss, while additional capacity and capabilities will be added to the Bioanalytical Center of Excellence in Assen.

Ardena Expands Bioanalytical Services in the Netherlands

Scorr Marketing Insights

to highlight best practices for preparing for 2025.

How aligned marketing and business development goals drive long-term growth and customer success.

The Critical Role of Marketing-Sales Alignment

The importance of aligning marketing and sales efforts to maximize impact and revenue potential.

Overcoming Planning Challenges in a Dynamic Market

Strategies for creating adaptable, data-driven plans that succeed despite market shifts.

Alec McChesney (BD Director, SCORR Marketing) discusses goal setting and alignment between life sciences marketing and business development teams.

Strategic Insights for 2025

ViaNautis Bio (ViaNautis), a UK-based biotechnology company specializing in delivering targeted genetic nanomedicines, announced on Oct. 28, 2024 that it has entered a collaboration agreement with Eli Lilly and Company (Lilly) in which Lilly will use ViaNautis’ proprietary polyNaut platform to develop precision therapeutics carrying genetic cargos. The collaboration aims to precisely deliver these therapeutics to prioritized tissues to address significant unmet medical needs.

Under the agreement, Lilly will pay ViaNautis an initial upfront payment with the short-term potential of making additional payments, including research-based milestones. ViaNautis is eligible to receive further milestones and royalties contingent upon specific cargo-loaded polyNaut-based products entering clinical development and reaching and reaching commercialization.

“This collaboration with Lilly is a testament to our polyNaut platform, which is also driving a highly differentiated emerging pipeline for severe life-limiting diseases. Combining our scientific know-how to precisely deliver genetic nanomedicines targeting difficult-to-reach sites, with Lilly’s extensive drug development and commercialization expertise will accelerate the creation of novel therapies to improve patient outcomes,” said Francesca Crawford, PhD, co-founder of ViaNautis, in a company press release.

The company’s proprietary polyNaut nanovesicles are designed to precisely target specific tissues and cell types to deliver genetic materials. The technology aims to improve the current delivery of genetic medicines and hold the potential to transform treatment for various diseases, according to the company in the press release.

“I am very excited about our collaboration with Lilly to develop novel genetic medicines for patients in need. I want to thank [Crawford] and the team for their hard work in getting to this key milestone, and I look forward to working with Lilly to accelerate our shared vision of delivering targeted genetic medicines,” said Adi Hoess, MD, PhD, chief executive officer of ViaNautis, in the release. The company is currently working on a pipeline of therapeutics in the central nervous system and cystic fibrosis disease fields (1).

Nanovesicles are being researched as alternatives to extracellular vesicles (EVs) for various applications, including drug delivery. As mediators of intercellular communication, EVs have gained growing interest from researchers for their potential use in the field of regenerative medicines or as a drug delivery vehicle. However, because EVs are derived from stem cells or progenitor cells, their use is limited primarily due to a lack of efficient and scalable production methods (2).

As a result, researchers are turning to nanovesicles, particularly biofabricated cell-derived nanovesicles, as an alternative to EVs that are offer scalable, efficient, and cost-effective production (2). Meanwhile, further research has been underway to develop and test simplified and rapid production methods for cell-derived nanovesicles that offer advantages over traditional methods in terms of yield and cost-effectiveness (3), which are anticipated to offer new approaches to therapeutic drug delivery.

 (accessed Oct. 30, 2024).
2. Ilahibaks, N. F.; Lei, Z.; Mol, E. A.; et al. Biofabrication of Cell-Derived Nanovesicles: A Potential Alternative to Extracellular Vesicles for Regenerative Medicine. 

 (12),1509. DOI: 10.3390/cells8121509
3. Goh, W. J.; Zou, S.; Ong, W. Y.; et al. Bioinspired Cell-Derived Nanovesicles versus Exosomes as Drug Delivery Systems: a Cost-Effective Alternative. 

The partnership will use ViaNautis’ proprietary polyNaut technology platform to develop genetic medicines that can precisely target tissue types.

Lilly and ViaNautis Bio Partner on Development of Novel Therapeutics Delivering Genetic Cargo

Abzena, an end-to-end contract development and manufacturing organization, is expanding its quality control testing capabilities at its San Diego, Calif., biologics development and current good manufacturing practice site, the company announced on Oct. 30, 2024. The expansion is part of the company’s strategy to meet market demand for quality testing. According to Abzena, the additional laboratory space will enhance its existing analytical toolkit for antibodies with microbiology release testing. The expansion will also improve scalability with advanced materials separation.

The standalone microbiology lab offers separate product testing from other areas of the facility, in alignment with industry and regulatory standards. Product microbiological testing is segregated from utility and environmental microbiological testing in order to minimize cross-contamination. Production capacity is optimized by the separation of high volumes of clinical materials, which results in yields up to 99%, according to the company. “This design methodology offers superior operational efficiency and improved scalability while minimizing overall ecological impact,” the company stated in a press release (1).

“This announcement comes at a very timely moment with World Quality Month quickly approaching. As an organization focused on quality excellence, increasing our QC [quality control] footprint is a testament to our commitment to continuous improvement and innovation,” said Troy Wright, senior vice-president and global head of Quality at Abzena, in the release. “This expansion provides even greater sample integrity in the management of our microbiological testing capabilities. We are now positioned to deliver faster results and better support for our customer network, ultimately providing quality and compliant products to patients around the world.”

In other Abzena news, the company announced on Sept. 26, 2024 that its mammalian cell line development platform, AbZelectPRO, reduces timelines by more than 30% and improves overall protein production levels. The platform can bridge from DNA to research cell bank in 10 weeks and produces up to 8 g/L of high-performing titres before process development, according to the company (2).

Abzena recently attended CPHI Milan in October 2024, and 

caught up with Nicolas Camper, senior director—Bioconjugation Chemistry at Abzena, to talk about advancements in conjugation and linker technologies in antibody-drug conjugate (ADC) development and manufacturing (3).

“There have been a lot of new developments in terms of conjugation and linker technologies. There is a definitive move towards site-specific conjugation technologies and away from stochastic conjugation approaches that allows [us] to prepare better-defined antibiotic-[drug] conjugates,” Camper said in the interview.

Another new development that has been observed over the past few years is that linkers are becoming more sophisticated. “Quite often, when you conjugate cytotoxic drugs, they are quite hydrophobic, and that can impact the performance of your ADC. So, there has been a lot of effort put into developing more hydrophilic linkers,” Camper noted.

Abzena. Abzena Announces Major Expansion in Microbiology Laboratory Space in Suppor of Biologic Manufacturing. Press Release. Oct. 30, 2024.

Abzena. AbZelectPRO Enables Biopharma Customers to Reach their Research Cell Bank in 10 weeks with 8g/L. Press Release. Sept. 26, 2024.

Mirasol, F. CPHI Milan 2024: New Developments in ADC Technologies. 

The company will be expanding its quality control testing capabilities at its San Diego, Calif. biologics development and manufacturing site.

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach