Drug Solutions Podcast

Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality.

Streamlining Equipment Quality and Flexibility

Opportunities and developments in particle engineering are providing developers with the tools to advance drug candidates successfully.

Putting a Spotlight on Particle Engineering

Advancements in soft capsule technology can enable the development of soft capsule formulations.

Novel Formulations and Line Extensions with Soft Capsule Technology

Examining new approaches, novel technologies, and the structural evolution of the raw materials market.

Examining Trends in Oral Solid Dosage Manufacturing

Replacing a step in sample preparation with an automated approach improves both method precision and productivity.

Automating a Critical Step in Glycoprotein Analysis for Vaccine Manufacture

Advancing OSD: Continuous Production Considerations and Dose-Level Authentication

Drug Digest

AstraZeneca announced its acquisition of Neogene Therapeutics, a clinical-stage biotechnology company developing next-generation T-cell receptor therapies (TCR-Ts), on Nov. 29, 2022. AstraZeneca will pay $200 million in upfront fees, with an additional $120 million to be paid in both contingent milestones and non-contingent consideration. The transaction is expected to close in the first quarter of 2023.

Neogene Therapeutics has focused on developing TCR-Ts for the treatment of cancer. According to a company press release, while most T-cell therapies focus on modifying the immune system’s T cells to recognize proteins expressed on the surface of cancer cells. TCR-Ts, however, can recognize intracellular targets like cancer-specific mutations, which presents opportunities for previously inaccessible targets.

“This acquisition represents a unique opportunity to bring innovative science and leading experts in T-cell receptor biology and cell therapy manufacturing together with our internal oncology cell therapy team, unlocking new ways to target cancer,” said Susan Galbraith, executive vice-president, Oncology R&D, AstraZeneca, in the press release. “Neogene’s leading TCR discovery capabilities and extensive manufacturing experience complement the cell therapy capability we have built over the last three years and allow us to accelerate the development of potentially curative cell therapies for the benefit of patients.”

“We are excited to work together with AstraZeneca towards our shared mission of transforming the treatment options for patients with solid tumors using next-generation [TCR-Ts],” said Carsten Linnemann, CEO, Neogene, in the release. “Our expertise, clinical portfolio and platform technologies in this area combined with AstraZeneca’s leadership in oncology and global footprint mean we are well-positioned to translate pioneering science into novel treatments for hard-to-treat cancers.”

Articles

AstraZeneca inked a deal worth up to $320 million to purchase Neogene Therapeutics, a biotech start-up focused on T-cell receptor therapies.

AstraZeneca Acquires Neogene Therapeutics for $320 Million

Immutep, a clinical-stage biotechnology company, announced that it had signed a second clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer, on Nov. 29, 2022. The new agreement concerns INSIGHT-005, a Phase I clinical study of Immutep’s lead candidate eftilagimod alpha, a soluble lymphocyte activation gene 3 fusion protein, in combination with avelumab in patients with urothelial cancer. It follows the INSIGHT-004 trial, which evaluated the treatment in patients with advanced solid cancers and posted results in June 2021.

According to a company press release, INSIGHT-005 will be an investigator-initiated explorative, open-label study evaluating the safety and efficacy of the drug in up to 30 patients with metastatic urothelial cancer. Jointly funded by Immutep and Merck KGaA, the study will be conducted in Germany by the Institute of Clinical Cancer Research, Krankenhaus Nordwest. It is expected to begin enrollment in the first half of 2023.

“We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options,” said Marc Voigt, CEO, Immutep, in the release.“INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of [eftilagimod alpha] and avelumab in various solid cancers, including deep and durable responses in patients with low or no [programmed death-ligand 1] expression and in indications that typically do not respond to immune checkpoint therapy.”

The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.

Pfizer, Merck KGaA, and Immutep Enter into Second Clinical Trial Collaboration Agreement

Aptamer Group, a synthetic antibody provider, announced the opening of its new facility in York Science Park, United Kingdom, on Nov. 28, 2022. The 18,000 ft² facility is designed to increase capacity and facilitate delivery of the company's Optimer binders, next-generation aptamers that can be used as synthetic antibody alternatives. In addition to discovery and development, a portion of the new lab will be dedicated to validation and assay development.

“We are excited to move to the new purpose-developed site for Aptamer Group,” said Arron Tolley, CEO, Aptamer Group, in a company press release. “This will enable us to keep up with the increased demand for our Optimer technology and the growth of the team at our new larger lab and office facilities. This expansion will mean Aptamer is able to work on larger-scale projects that can be processed faster to support our partners with Optimers as a robust and much-needed alternative to antibodies.”

Aptamer’s new 18,000 ft² facility will expand the company's capacity to deliver novel binders for bioprocessing, diagnostic, and drug development.

Aptamer Group Opens New Facility in United Kingdom

Etihad Cargo has been awarded Center of Excellence for Independent Validators (CEIV) Pharma recertification by the International Air Transport Association (IATA), and it is one of the only 37 airlines to hold IATA CEIV Pharma certification globally, according to the company. 

The achievement of IATA CEIV Pharma certification was first achieved in 2019 in conjunction with the hub at Abu Dhabi International Airport and Etihad Airport Services Cargo. Following this, Etihad went on to become the first airline in the Middle East and the third globally to hold the trilogy of CEIV Pharma, CEIV Fresh, and CEIV Live Animals certifications. 

The recertification was achieved following an audit by independent validators that assessed the carrier’s capacity to control and enhance its processes through a checklist that focused on Etihad’s Cargo’s Quality Management System that incorporates elements such as supplier management, training programs, processes and procedures, audit programs, and quality enhancement. 

Reaching recertification status represents the company’s dedication to pharmaceutical transportation product PharmaLife’s full compliance with specific pharmaceutical regulations, like IATA Temperature Control Regulations (TCR), Good Distribution Practices (GDP), a quality system for warehouses and distribution centers dedicated to medications and life sciences products.

"Etihad Cargo is proud to achieve IATA CEIV Pharma recertification following an extensive audit. This industry-wide standard ensures Etihad Cargo's operations and staff comply with all applicable standards, regulations and guidelines expected from pharmaceutical manufacturers. The benefits of CEIV Pharma certification extend to Etihad Cargo's customers, who can be assured the carrier's dedicated pharma cargo management constantly monitor and analyze the quality and safety of Etihad Cargo's PharmaLife product performance,” said Martin Drew, senior vice president, Global Sales & Cargo at Etihad Aviation Group, in a press release. "Etihad Cargo fully supports Abu Dhabi's vision of becoming a life sciences and pharmaceutical hub. Achieving recertification and providing world-class pharmaceutical logistics solutions demonstrates Etihad Cargo's capabilities in seamlessly transporting life-saving medicines and the latest treatments around the world from the carrier's Abu Dhabi hub."

Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally. 

Etihad Cargo Achieves IATA CEIV Pharma Recertification for Pharmaceutical Logistics

Novartis and Medicines for Malaria Venture (MMV) have decided to progress ganaplacide/lumefantrine-solid dispersion formulation (SDF) into Phase III development for the treatment of patients with acute uncomplicated malaria due to 

. This decision comes from the threat of resistance to current malaria treatment growth.

Ganaplacide is a novel agent combined with a new formulation of lumefantrine optimized for once-daily dosing, and it has the potential to clear malaria infection, like artemisinin-resistant strains, and to block the transmission of the malaria parasite.

 malaria is primarily treated with artemisinin-based combination therapies (ACTs), like artemether-lumefantrine, and are still highly effective and well tolerated.

A Phase II, open-label, randomized controlled study was conducted in 524 adults and children with acute uncomplicated malaria due to plasmodium falciparum infection. Further, the ganaplacide/lumefantrine-SDF combination met the primary objective in both adults and children. The patients who received a once-daily dose of ganaplacide/lumefantrine-SDF throughout a three-day duration had a similar response to treatment to the rate observed in patients who received twice-daily artemether-lumefantrine control therapy during three days.

A large Phase III pivotal trial that is set to start in 2023 will compare the efficacy of ganaplacide/lumefantrine-SDF to the current “gold standard” artemether-lumefantrine.

“The emergence of artemisinin resistance demands urgent action to develop new antimalarials. We need non-artemisinin-based medicines with novel mechanisms of action against resistant parasites, and simple, easy-to-follow dosing schedules to help increase treatment adherence,” said Sujata Vaidyanathan, MD, Head Global Health Development Unit, Novartis, in a press release. “The earlier we have new compounds and the faster the world adopts them, the better chance we stand of beating resistance.”

FDA granted Fast Track Designation and Orphan Drug Designation in August 2022 for the combination of ganaplacide and lumefantrine-SDF for the treatment of acute, uncomplicated malaria.

“We are increasingly seeing parasites with decreased sensitivity to artemisinin, even in Africa,” said Timothy Wells, MD, Chief Scientific Officer, MMV, in a press release. “If the Phase III trial is successful, this new combination will increase the number of options available to countries and help save the lives of children at risk of this devastating disease.”

The decision to move forward in Phase III development stems from the threat of resistance to current malaria treatment growth. 

Phase III Study for Novel Ganaplacide/Lumefantrine-SDF Combination in Adults, Children with Malaria Announced

Cell therapy and large-molecule supply chains have traditionally been treated as different entities, but as research around biologics, regenerative medicine, and cell and gene therapies (CGT) has progressed, the gap between these supply chains is quickly closing. Typically, cell therapy products, particularly personalized ones, have needed to be controlled and tracked dose by dose because they need to be delivered to the specific patient for whom they were made. The risk of this process failing within the supply chain could result in the death of a patient, either due to a complication, such as graft versus host disease, or simply because the therapy is no longer being a viable option for a patient who will often have exhausted standard treatment pathways at this point.

This has, over the years that autologous cell therapies have been developing, increasingly pushed therapy developers into utilizing digital eco-systems to support and track the supply and value chains of these therapies from the point where starting material is obtained, through to the final administration of the product. The data that feed into the full Chain of Identity (CoI) and Chain of Custody (CoC) records for these therapies can come from a vast array of systems, potentially operated by different stakeholders in the supply chain such as logistics companies, healthcare sites, and manufacturers. Manually accessing and connecting the information from these systems to create a full CoI and CoC record is time consuming and is prone to error and data duplication. This not only makes it costly, but poses a challenge when production needs to be scaled up and limits the use of the data that are collected in terms of reporting and analysis.

For the sake of both simplicity and scalability, many developers have invested in buying or developing cell orchestration solutions to unite all these disparate systems and pull the relevant information into a central, reportable, and searchable system that can help to drive and control all the steps on a therapy’s journey. These orchestration solutions also have the advantage of acting as a portal into the data that each specific stakeholder within the supply chain needs, ensuring that therapies are handled quickly and efficiently through the various complex steps.

Historically, large-molecule biologics, such as 

 gene therapies, have not demanded this level of integration, and tracking as the lack of personalization meant that the supply chain was shorter and did not include the complexity of dealing with patient-specific starting material or patient data. However, the sector has more recently witnessed several new approvals, and drugs with costs of millions of dollars per dose and similar market price estimates are made for more of these therapies in pivotal clinical trials. It is these products that are beginning to change the supply chain needs.

The challenges associated with supporting these drugs through their supply chain are not all entirely new, with many akin to those encountered in cell therapy value chains over the past 10 years, and as a result, large-molecule developers are increasingly looking at the solutions that have been developed to support cell therapy products as challenges begin to align:

Shipping conditions and chain of custody remain a priority for both therapy types.

Enhanced reporting and additional product security for high-cost large molecule drugs is desirable to minimize losses in the supply chain.

High-cost drugs make tracking each patient’s treatment attractive, particularly where dosage is linked to patient specific variables like weight, as it can reduce product waste and loss.

Reimbursement models that are linked to patient outcome require efficient tracking of individual patient milestones and making these data accessible to the therapy developer.

This article examines how data integrating digital ecosystems are increasingly being deployed to orchestrate cell therapies and could help to address security and traceability challenges throughout the supply chain for the newer, high-cost drug products as more focus shifts to the supply chain post manufacture.

Cell orchestration systems historically focused on tracking patient starting material, manufacturing intermediates, and the final drug product. Growth in the sector and increasing numbers of therapies reaching commercialization have made manufacturing scheduling and resources management more significant. Being able to schedule accurately in an industry that potentially has restricted resources is more important now than ever.

As a result, more manufacturing systems are commonly being integrated into the cell orchestration eco-system, such as enterprise resource planning (ERP), manufacturing execution systems (MES), and scheduling management software systems. These integrations make the data that are required for tasks such as detailed batch and raw material tracking easily accessible to the developer in real-time and match it back to specific patient doses.

Additionally, cell orchestration systems already have the functionality to link the large quantities of data relating to shipping and storage conditions (e.g., temperature) to the therapy journey and make this available as part of the CoI record, as well as matching the data with the CoC record to show who was responsible for the material should an excursion become apparent. In addition, high use of digital workflow and data analysis within these eco-systems means that excursions can be proactively flagged to decision makers to try to mitigate loss, reduce costs, and avoid delays. For example, if a supply chain team get advance information about raw materials being delayed or becoming unavailable with enough warning, the manufacture of the product can be rescheduled or rerouted, and the downstream supply chain activities adjusted quickly.

Data compiled to form audit history of a cell therapy within an orchestration system will track all batches/lots/handlers etc. for each patient-specific therapy in a full, time-stamped audit record, facilitating corrective action in the event of an issue or investigation. With many high-cost therapies looking likely to move to patient outcome related reimbursement models, the availability of these data on a patient-by-patient basis could prove invaluable to assist with outcome-related reimbursement.

Where batch sizes are larger and drug product non-specific, there is less of a need for orchestration; however, moving to a patient-specific model where the drug product cost is high makes having finer control to avoid stock build up and minimize storage times advantageous.

The control and visibility that an integrated supply chain offers extends the control and visibility that the drug developer or license holder has over the manufacturing process, allowing them to see and react to the stages within the process if something needs to be altered or a query is raised. With high-cost large molecule drugs often being made in small batches and dispatched on a patient-specific basis, as well as potentially being dispensed on a patient characteristic (e.g., weight), the number of units shipped will be tailored to the patient’s required dose. For this to be done accurately and efficiently, an established and secure way of feeding critical patient data into the supply chain and maintaining a link to the patient’s drug product-specific characteristic for each dose dispatched becomes necessary. It is also important to consider how to produce compliant, patient-specific drug product labelling to preserve the CoI and make it available at key check points where the product is handled, reducing the chance of error.

Offering developer’s supply chain teams visibility into selected data that are held in ERP and MES systems via automated data transfer of specified fields makes it easier for them to deal with short shelf-life, high value products, as they have harmonized access to the information that can drive forecasting and resource availability. Information flow can be two-way through the eco-system, so manufacturer’s planning teams can gain access to the patient schedule from the point where they are approved for the drug. This advance warning and scheduling detail could prove critical in minimizing surplus stocks and predicting both demand and capacity to supply, while offering supply chain teams greater control over the timing, scheduling, partners, and routing used to manufacture and dispatch a product.

Where cost per treatment is high, security concerns within the supply chain may extend beyond ensuring that the product is not tampered with, in addition to the physical condition of the product and the shipping containers. The ability to live track a product to see exactly where it is and who has both physical custody and financial title is important, as is having a full record of the condition of the product at each handover. This information can be fed back to supply chain teams in real-time within an integrated eco-system, with the ‘hub’ system triggering notifications or alerts as required if an event requires a decision or a response.

In addition to traditional drug security concerns, the inclusion of patient data in the supply chain (e.g., in the format of personalized labels) could bring new regulatory risks into the supply chain that traditional pharmaceutical processes do not need to consider. When operating internationally, this can be further complicated by the fact that data protection regulations vary locally, and labelling may need to be managed in multiple languages or over several different templates. Allowing manufacturers to access label formats owned and controlled by the drug developer but printed locally with patient-specific information is another advantage of having a central system which is integrated and accessible to stakeholders throughout the supply chain process.

There are also potential benefits that could be realized from gaining access to detailed shipping data. Broad analysis for various shipping routes, suppliers, or handling centers can identify common points of failure, aid risk analysis, and identify trends that can help inform future route planning and help to minimize time in transit and increase speed to treatment. All of these aspects are likely to be important factors in the commercial modelling of high-cost large molecule drugs, as the need to supply scales up and the incentive to ensure that product moves through the steps of the supply chain swiftly increases.

Within high-cost treatments, outcome-based reimbursement models appear to be becoming more common, with reimbursement for the product being phased over the recovery period for the patient. Where there is a ‘clock ticking’ from the point of drug product administration, being able to record key post-treatment milestones on a patient-by-patient basis and share the information quickly and efficiently with relevant stakeholders could significantly speed up the reimbursement times for developers, easing the financial burden of supplying these treatments.

This may mean sharing information over several key systems, such as:

an orchestration system that records when drug administration has taken place

patient hub services or patient management systems that are managing aftercare appointments and follow up

invoicing or customer management systems, which could include various user profiles of the stakeholders.

The ability to do this quickly, efficiently, and securely while ensuring that data privacy rules are adhered to is likely to become more pressing, as more drugs fall onto this type of reimbursement model.

As the nature of many of the newly researched large-molecule biologics continues to evolve, and successful medications emerge that cost millions of dollars per dose, it is likely that the supply chain will have to make significant adjustments to manage the increased risk, changing commercial models and the potential of patient-specific data entering the supply chain.

Activities traditionally associated with the cell therapy supply chain, such as real-time tracking and monitoring, patient-specific labelling and dosing, and phased reimbursement from the point of drug administration, are all likely to become more relevant to developers who have products that adhere to this model.

As these challenges have been present in the cell therapy space for the past 10 years, a wealth of digital tools that have been developed to help manage the risk in the supply chain at sufficiently low cost and resource to make scaling up the production and delivery of a therapy sustainable. Manual and paper-based systems have been seen to be prone to weaknesses, labor intensive to manage, and deemed high risk by approving bodies. For example, FDA delayed the approval of the autologous cell therapy Dendreon for several years until the developer could demonstrate that the supply chain was sufficiently well controlled for the product to be approved. This means that when using paper-based traceability at the point of scaling up, large numbers of administrators are required to manage even small increases in patient numbers as these complex supply chains have been seen to have hundreds of manual steps per dose for a patient specific process that is not supported by automation and integration.

As the supply chain environment continues to move toward an integrated digital landscape, vast quantities of data are available for capture and analysis, ensuring that the integrations are robust and secure is critical, which becomes essential when patient data are involved. Utilizing a central system, like a cell orchestration platform that can act as a hub for data that stakeholders and systems within the supply chain can enter/exchange data into directly, helps to minimize data duplication and errors but also restricts data access and ensures that the data controller, or the drug developer, always retains the information from a security and a hosting point of view.

There are a broad variety of solutions and methodologies for creating integrated eco-systems, which will mostly be dependent on the core systems and technologies that are already in place with the various supply chain constituents. However, within the CGT industry, there are already eco-systems and collaborations that have begun to form, and supply chain experts within both developers and supply partners who have amassed experience on how to tackle some of the key challenges that come with designing and implementing integrated solutions. If the large-molecule supply chain continues to produce drugs with extremely high price points, then drawing on the experience collated by those in the cell therapy sector could be invaluable.

High-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.

Drug Product Security

SpectrumX, a UK-based healthcare and pharmaceutical company, announced plans to advance with the next stage in clinical development of its respiratory drug candidate, SPX-001, in the United Kingdom.

The company will submit a combined Clinical Trial and Ethics Committee application for a placebo-controlled Phase IB influenza viral challenge study of SPX-001 in healthy participants to the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2022 per regulatory guidelines.

SPX-001 is a nebulized respiratory infection drug candidate based on SpectrumX’s licensed hypochlorous acid (HOCI)-based SPC-069 drug substance. The substance is believed to have broad-spectrum antipathogenic properties.

“We believe SPX-001 could be a significant new weapon in the fight against viral respiratory infections, and this is a critical milestone in progressing our drug candidate toward targeted market authorization approval,” said Damien Hancox, CEO of SpectrumX, in a press release. “We would like to thank the MHRA for their helpful guidance and responses to our initial proposal to begin human clinical trials, and we hope this brings us another step closer to trialling what we believe is a revolutionary treatment for respiratory infections.”

If the application is approved, it will be the first in-human trial to supply SPX-001 via a nebulizer to test its efficacy and safety in comparison to a placebo treatment in healthy subjects infected with influenza. After a successful completion of the planned trial, SpectrumX will then proceed with further trials in patients with respiratory infections to gather the additional necessary data for a market authorization approval.

SpectrumX is already in the production process for SPX-001 and working with a good manufacturing practice (GMP)-certified partner, which will quicken the trial-readiness once the approvals are received.

“After productive discussions at a scientific advice meeting with the MHRA, during which we presented our lab-driven data, supporting evidence from existing literature, and key features of our novel solution, SPX-001, supporting its potential effects in combating respiratory infections, as well as our proposed clinical study protocol, I am pleased that we are one step closer to starting our clinical trial programme and the subsequent processes that are essential to market authorization,” said Donna Lockhart, MD, Consulting Head of Medicines at SpectrumX, in a press release.

SPX-001, a respiratory drug candidate, will be submitted through a combined Clinical Trial and Ethics Committee application for further advancement in the clinical stages. 

Next Step in Clinical Development of Respiratory Drug Candidate SPX-001 Confirmed

FDA announced the approval of CSL’s Hemgenix (etranacogene dezaparvovec), the first one-time gene therapy for adults with hemophilia B, on Nov. 22, 2022. The treatment is approved for use in adults with hemophilia B who currently use factor IX prophylaxis therapy, or those who have had life-threatening hemorrhage or repeated spontaneous bleeding episodes. The therapy will cost approximately $3.5 million, making it the most expensive single-use therapy in the United States.

According to the agency press release, Hemophilia B is a genetic bleeding disorder resulting from missing or insufficient levels of blood clotting Factor IX, a protein needed to produce blood clots to stop bleeding. In an ongoing clinical trial, etranacogene dezaparvovec reduced the rate of annual bleeds by 54%. Additionally, 94% percent of patients were able to discontinue factor IX prophylaxis and remained prophylaxis-free.

“Gene therapy for hemophilia has been on the horizon for more than two decades. Despite advancements in the treatment of hemophilia, the prevention and treatment of bleeding episodes can adversely impact individuals’ quality of life,” said Peter Marks, director, FDA Center for Biologics Evaluation and Research, in the release. “Today’s approval provides a new treatment option for patients with Hemophilia B and represents important progress in the development of innovative therapies for those experiencing a high burden of disease associated with this form of hemophilia.”

“As part of our promise to patients, CSL is committed to delivering innovative and groundbreaking solutions to address unmet medical needs, and we are proud to introduce the next wave of breakthrough medicines for people living with hemophilia B,” said Paul Perreault, CEO and managing director, CSL, in a company press release. “We recognize and thank all trial participants, scientists and investigators—without whom this important achievement would not have been possible—and look forward to seeing the positive impact of HEMGENIX on the hemophilia B community.”

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

FDA Approves $3.5 Million Hemophilia B Gene Therapy

Merck, known as MSD outside of the United States and Canada, announced its intention to acquire Imago BioSciences, a clinical-stage biopharmaceutical company focused on bone marrow disorders, on Nov. 21, 2022. Per the terms of the definitive merger agreement, Merck will acquire Imago for approximately $1.35 billion in total equity. The transaction is expected to close in the first quarter of 2023.

According to a company press release, Imago specializes in developing new medicines for the treatment of myeloproliferative neoplasms and other bone marrow diseases. Imago’s lead candidate is bomedemstat, an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor. Due to the role that LSD1 plays in the function of malignant blood cells, targeting it is intended to provide a new mechanism of treatment for various blood cancers. It is currently being evaluated in multiple Phase II clinical trials for the treatment of essential thrombocythemia, myelofibrosis, and polycythemia vera, among other indications.

“We continue to invest in our pipeline with a focus on applying our unique capabilities to unlock the value of breakthrough science for the patients we serve,” said Robert M. Davis, president and CEO, Merck, in the release. “This acquisition of Imago augments our pipeline and strengthens our presence in the growing field of hematology.”

“This milestone is a testament to more than a decade of pioneering research by Imago scientists and the entire Imago team’s unwavering dedication to improving the lives of patients,” said Hugh Y. Rienhoff Jr., founder and CEO, Imago BioSciences, in the release. “This agreement leverages Merck’s industry-leading clinical development expertise to maximize the therapeutic potential of bomedemstat while providing important value for shareholders.”

Merck will purchase Imago BioSciences, a biotechnology company focused on bone marrow disorders, for approximately $1.35 billion. 

Merck Announces $1.35 Billion Acquisition of Imago BioSciences

Sartorius BIA Separations (BIA), a bio-chromatography company, and Exopharm, a company focused on medicines using exosomes, or extracellular vesicles, announced on Nov. 22, 2022 that they have entered into a formal collaboration. The companies have signed a Material Transfer Agreement that aims to use Exopharm’s patented LEAP technology alongside BIA’s Convective Interaction Media chromatography for improved large-scale therapeutic exosome production and commercialization.

According to a company press release, exosomes have advantages over alternative nanoparticle delivery technologies, as they are non-toxic, efficient at delivering RNA cargoes into cells, and able to do so without eliciting an immune response. Exosomes can also be engineered to provide specific delivery as well as repeated dosing.

“BIA sees the potential in exosomes for new and innovative therapeutic applications and understands that purification of exosomes has held back their adoption as a non-viral drug-delivery technology,” said

Aleš Strancar, co-founder and managing director of BIA, in the release. “We believe that BIA’s CIM monolith technology and Exopharm’s exosome-specific LEAP ligands can work synergistically together to enhance specificity, efficiency and capacity of industrial exosome purification processes. This work with Exopharm has the potential to be a game-changer in the emerging exosome field.”

The agreement aims to develop integrated technology for large-scale exosome production. 