New biotherapeutics both drive and benefit from innovative development technologies.

Innovation Demands and Spurs Invention

Moderna initiates BLA submission; GSK Earns EUA for mAb Treatment

Vaccine Makers Plan for Global Distribution

Complex formulations, personalized medicines, and more are driving innovations in drug packaging.

Injecting Innovation into Drug Packaging

A task force establishes scientific data for integrity test activities. 

Reducing Sterile Filtration Risk

Automation offers benefits for sterile manufacturing in 503B facilities. 

Robotics for Drug Compounding

on June 11, 2021 that supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 that contain API manufactured at Emergent BioSolution’s Maryland facility around the same time as a known contaminated batch. According to EMA, batches of the vaccine that have been released in the EU are not contaminated, and the recommendation is a precaution to safeguard supplies.

Vaccine production was suspended at Emergent’s Bayview, Md. facility in April 2021 after a manufacturing error caused loss of product and an 

 found good manufacturing practice violations.

EMA stated in a press release that it is working with FDA and international partners to ensure the quality of COVID-19 vaccines.

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As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

 on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing.

The new site follows two other sites approved by CHMP in June for the manufacture of API and finished product intermediates in the United States. “Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union,” the agency stated in a press release.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine

In a June 10, 2021 press release, the Centre for Process Innovation (CPI) has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.

Through the partnership, MMIC will draw upon DFE Pharma’s expertise in the development of excipients for oral solid-dosage medicines to help address key challenges currently facing the industry. More specifically, DFE Pharma will help to advance Phase 1 of the Grand Challenge 1, which aims to develop a novel digitally twinned continuous direct compression (CDC) platform to reduce waste and cut costs during the manufacture of oral dosage medicines.

“We are excited to be collaborating with global excipient manufacturer DFE Pharma; well-respected in the market for its excellence in particle technology and particle and process interactions,” said John Arthur, director of MMIC at CPI, in the press release. “This partnership will enable Phase 1 of Grand Challenge 1 to be delivered more quickly and cost-effectively.”

Bas van Driel, CEO at DFE Pharma, added, in the press release, “We are delighted to establish a closer relationship with the MMIC, the [United Kingdom’s] leading initiative to drive innovation in pharmaceutical manufacturing, to help ensure the success of Grand Challenge 1. This unique opportunity will allow us to work alongside and showcase our world-class capabilities in excipient development to the other partners.”

CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.

DFE Pharma Becomes Newest Partner in MMIC Collaboration

Immuno-oncology company, Immodulon, has announced, in a June 8, 2021 press release, the receipt of an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate, IMM-101.

The patent application specifically relates to combining IMM-101 with various classes of immune checkpoint inhibitors (CPIs) for the treatment of any tumor type. If granted, the patent will further support the company’s intellectual property (IP) position around the lead drug candidate ahead of the commencement of a potentially pivotal study in 2022, and the expiration of the patent would be in 2034.

“We are pleased to have received this indication of allowability of the claims for this key European Patent Application that will bolster our IP position around IMM-101, our lead drug candidate, in combination with immune checkpoint inhibitors as a treatment for cancer,” said Jaap Kampinga, CEO of Immodulon, in the press release. “IMM-101 has a unique mechanism of action—principally activating dendritic cells of the human immune system via the Toll-Like receptor 2. Studies to date suggest that IMM-101 is synergistic to the effects of the main classes of checkpoint inhibitors and presents no added safety burden.”

Furthermore, Kampinga stated in the press release that the company has an open investigational new drug application in the United States for the lead drug candidate in sarcoma and has also been given orphan drug designation in the European Union and the US for treatment of pancreatic cancer.

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

Immodulon Gains Allowability of Claims for Key European Patent Application

The Cell and Gene Therapy Catapult (CGT Catapult) has formed a consortium of more than 20 organizations aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

In a June 8, 2021 press release, CGT Catapult announced the formation of the consortium, which will assess multiple process analytical technologies (PAT) that are either new or routinely used in other industries. Through collaboration and sharing of information, the consortium will act as a catalyst to accelerate the development of the necessary knowledge and understanding at reduced cost and investment risk to each organization.

“The industry needs to make a giant leap in terms of analytical capability and the dynamic use of information to control and improve processes, product, and costs,” said Matthew Durdy, CEO at CGT Catapult, in the press release. “The coming together of these leaders in the field is a very important first step towards achieving this.”

“By sharing knowledge and data, the consortium members will be able to reap potentially huge benefits that could lead to more efficient processes in this vital field,” added Nicholas Medcalf, deputy challenge director—Medicines Manufacturing for Innovate UK, in the press release. “The Cell and Gene Therapy Catapult—supported by Innovate UK—is demonstrating its fantastic convening power in harnessing these leading industry players for the greater good of UK enterprise and innovation.”

The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

CGT Catapult Forms Consortium to Accelerate Manufacturing Technology Development

Researchers from the Chalmers University of Technology (Sweden) and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles, which is hoped to be able to accelerate the development of messenger RNA (mRNA) medicines.

According to a June 9, 2021 press release, the novel automated process has been designed to allow for the simultaneous monitoring and testing of large numbers of different lipid nanoparticles. Using fluorescent markers, the researchers have been monitoring and analyzing the movement of lipid nanoparticles through cells. Additionally, the new method has allowed the researchers to see if the mRNA, which is packed into the lipid nanoparticle, is able to produce the encoded protein once delivered.

“Instead of just seeing which lipid nanoparticles work best, we can now also understand what makes them work optimally, and use that knowledge to develop and test new improved nanoparticle formulations,” said Michael Munson, postdoctoral fellow at AstraZeneca R&D, who is affiliated to the research centre FoRmulaEx and is the first author of the study that was recently published in the journal 

“To reduce the risk of side effects, such as the immune system being triggered by the lipid particles, we want to use the lowest possible dose. This is particularly true for diseases which require long-term treatment,” added Elin Esbjörner, associate professor of Chemical Biology at Chalmers University of Technology and co-author of the study, in the press release. “In those cases, it is vital that the moment of endosomal escape is optimally timed, to allow the mRNA to get out into the cytoplasm with maximum effect.”

Furthermore, the researchers can assess how efficiently the lipid particles are delivered and how well they work in different types of cells using the method. Therefore, through the information gained from the method, it could be possible for drugs to be developed that are tailored to target specific tissues.

“The lipid nanoparticles work differently in different cell types. A formulation that works well for delivery to liver cells, for example, could be significantly different in lung cells,” stated Esbjörner, in the press release. “Our new method could help us understand why such differences exist, and to harness this knowledge to design new lipid nanoparticles tailored for different targets in the body.”

Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.

Novel Automated Process May Speed Up Development of New Medicines

Roambee, a California-based supply chain visibility provider, has acquired Modum, a Swiss pharma last mile-focused cold chain monitoring player, it was announced in a June 8, 2021 press release.

Through this acquisition, Roambee will be able to expand its cold chain visibility, covering primary, secondary, and the last mile delivery use cases. The acquisition will see key executives from Modum take up leadership roles at Roambee, which will provide the company with pharma domain knowledge and last mile expertise for its product strategy.

“Joining forces with Roambee was natural for Modum due to our shared mission to ensure the timely availability of effective, original products in the medical supply chain,” said Modum's CEO Simon Dössegger, in the press release. “Modum will enhance Roambee's cold chain footprint with a proven last mile visibility technology to extend the Roambee product proposition to a unique global end-to-end visibility solution. When combined with Roambee's strong multimodal shipment monitoring capabilities, we can offer granular visibility all the way from manufacturing to a patient's home at scale.”

“While most visibility service providers claim to deliver real-time visibility, they rely on carrier data. Insights will never be as granular, real-time, and accurate as sensor driven insights, which is key to logistics automation,” added Sanjay Sharma, CEO of Roambee, in the press release. “With Modum, Roambee will enable customers to automate their logistics through radically simple access to sensor-driven signals, delivered by our immersive, location-aware platform—not only for pharma, but also for fresh produce and food/beverages.”

Roambee has acquired Modum, a Swiss pharma last mile-focused cold chain monitoring player, expanding its cold chain visibility capabilities.

Roambee Expands Cold Chain Visibility Offering Through Modum Acquisition

Bioprinting start-up company, Brinter, has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor. The financing announcement was made in a June 10, 2021 press release.

The monies raised will be used by Brinter to expand operations internationally in Europe and the United States. The company’s modular multi-material 3D bioprinting solution offers a scalable approach to shorten and enhance the productivity of the scientific process and bio-manufacturing.

“We are excited to have the backing of Innovestor who can help us accelerate the development of our operational capabilities and scale in new geographies,” said Brinter CEO Tomi Kalpio, in the press release. “Bioprinting has the capability to rapidly unlock the opportunities behind long-running but unrealized science and research, and plays a key role in pushing the frontier of medical science. This will result in an improved quality of life for patients through the expansion of more personalized treatment and the ongoing development of bioprinted ‘spare parts’ that can save lives.”

“Brinter is an exciting addition to our portfolio as it not only fits in our focus areas of industrial and health technologies, but the company’s competitive advantages of multi-material printing capabilities, modularity, and scalability combined with their own easy-to-use software application were very convincing,” added Wilhelm Lindholm, CEO of Innovestor, in the press release.

Brinter has successfully closed a €1.2 million (US $1.5 million) seed funding round, which was led by the early-stage venture capitalist Innovestor.

Brinter Successfully Closes Seed Funding Round Led by Innovestor

Research-driven biopharmaceutical company, Boehringer Ingelheim, has joined the Quantum Technology and Application Consortium (QUTAC) as a founding member, it was revealed in a June 10, 2021 press release.

Ten German companies, based in the fields of pharmaceuticals, chemistry, insurance, and the automotive industry, make up the consortium, which is aimed at exploring industrial applications for quantum computing. Through advancing the potential industrial applications of quantum computing, QUTAC founding members hope to make a contribution to progressing the technology across both the German and European markets.

“As part of QUTAC, we will contribute to further advance the research for industrial solutions in the field of quantum computing,” said Michael Schmelmer, member of the board of managing directors of Boehringer Ingelheim with responsibility for Finance and Group Functions, in the press release. “Together with our partners at QUTAC, we want to create the basis for an efficient use of the quantum computing potential in the future. Even though it may still take some years until this technology is ready for industrial use, we need to define and explore a variety of specific use-cases across several industries now.”

Quantum computing has potential in research and development of pharmaceuticals, particularly for the accurate simulation and comparison of much larger molecular structures. Early research processes, which is an area of expertise for Boehringer Ingelheim, could benefit from this technology.

“Last year, we set up a dedicated Quantum Lab to explore specific applications for pharmaceutical research and development. Apart from these internal developments, partnerships with academia and the industry play an important role,” added Schmelmer in the press release.

Boehringer Ingelheim has joined the Quantum Technology and Application Consortium (QUTAC) as a founding member.

Boehringer Ingelheim Joins QUTAC as Founding Member

Syntegon Technology’s new GKF 60 for lab-scale capsule filling provides multiple dosing systems, including a new piezo dosing system as well as conventional dosing modules for dry powder inhalation (DPI), pellets, tablets, or liquids. The system has a mini-bowl station to ease scale-up to the next larger production machine.

The compact machine has six stations, and three filling stations can be integrated in parallel. The piezo station is designed to fill small quantities flexibly and, if possible, without product loss, which is especially important for high-priced active ingredients. This station can dose quantities as small as 0.1 mg filling weight, for example for toxicity or first-in-man studies. Each dosing station can be optionally equipped with a gravimetric, 100% weighing system for each component dosed.

A new Automated Process Development (APD) tool developed by Syntegon can be used on the GKF 60 to determine the optimum parameters for filling and automatically adjust them during the filling process.

The filler is available in a standard version, a version with containment, or a combi solution, and the machine has a new design for quick changeover that uses exchangeable cabin elements and a sophisticated cleaning concept. The standard version can also be easily retrofitted.

In addition, scale up to production is easy because the GKF 60 is compatible with the Syntegon's smallest production-scale capsule filling machine (the GKF 720).

New features of Syntegon’s GKF 60 capsule filler include a piezo dosing system, an Automated Process Development tool, and quick changeover to containment. 

Featured Content

Innovation Demands and Spurs Invention

Vaccine Makers Plan for Global Distribution

Injecting Innovation into Drug Packaging

Reducing Sterile Filtration Risk

Robotics for Drug Compounding