Outsourcing has become a crucial part of the biopharmaceutical industry, with many contract manufacturing organizations (CMOs) being the only facilities with the ability to produce vaccines and therapies in the vast volumes requested. Other reasons for outsourcing include the need to control costs/minimize internal staff and resources, getting a product out to the market in an efficient way, and having no alternative ways to complete manufacturing capabilities (1).

For the near future, CMOs are hoping to grow outsourcing to significantly higher levels in many different areas, with a focus on analytical testing,
toxicity testing, and fill/finish operations. In addition to these predictions, CMOs are already making shifts in their operations to have more options and advanced services (1).

An example of this is how many sponsor companies are heading toward contract development and manufacturing organization (CDMO) service agreements to further improve their processes. In October 2022, Societal CDMO entered two new contract development and manufacturing service agreements, which will provide an array of analytical method, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics (2).

The first contract focuses on services such as analytical method development and validation, technical transfer combined with formulation optimization, clinical trial batch manufacturing, and primary packaging for the drug. Meanwhile, the second contract targets on Societal CDMO’s services like formulation development, analytical method transfer and verification, and good manufacturing practice (GMP) batch manufacturing and fill/finish (2).

Other companies are focused on expanding their CDMO services for parenteral drugs to customers outside of the United States. For example, Terumo Pharmaceutical Solutions is set to offer end-to-end services with pre-filled syringes (PFS) design, molding, drug preparation, filling, assembly, and final packaging for biotech drugs and small molecules (3).

Additionally, the services would include early development stage to large-scale commercial production for global pharmaceutical customers, such as assembly of PFS with devices such as autoinjectors and needle safety devices (3).

With the ever-changing state of CDMOs, acquisitions are continuing to occur for the overall better development of the pharmaceutical industry (4).

Kindeva Drug Delivery, a CDMO, acquired iPharma Labs, which is a CDMO focused on inhaled medicines, in June 2022. iPharma comes from a specialization background in inhalation formulation and the development of liquid, dry powder, and propellant-based therapies and has worked with dry powder inhalation, soft mist inhalers, and nebulizers for both small and large molecules in the earlier stages of drug development (4).

Catalent has also completed the expansion of its clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shangai, China. The expansion has allowed for installation of additional refrigerated and deep-frozen storage, including the development of secondary packaging capabilities (5).

As new facilities begin to open, such as Thermo Fisher Scientific’s opening of a new facility in Hangzhou, China, more companies are aimed to be at the forefront of boosting biologics, sterile development, manufacturing capabilities, and more. In addition to offering integrated clinical and commercial drug substance and drug product capabilities, the company plans to feature commercial packaging and labeling capabilities in the near future (6).

The expansion of new facilities calls for an effort on new investments to better manufacture products. For example, Recipharm announced it would be advancing their CDMO with a new high-speed filling line for pre-filled syringes and cartridges at one of their sterile manufacturing facilities in Germany. The line will be fully Annex 1 compliant and designed to support both small- and large-volume projects (7).

As for trends in outsourcing strategies, the latest CPHI report predicts that a significant shift in outsourcing strategies is being experienced globally, with innovators planning out a product’s full lifecycle as early as the pre-clinical stage (8).

A key finding in the report found that “pharma-ready” synthetic routes are being planned much earlier in the development process, whereas “phase-appropriate development” is believed to be an outdated approach specifically when dealing with accelerated pathways. Further, the report mentioned that innovators will need to decide on using a
single end-to-end provider or a multi-provider model, and CDMOs need to reevaluate their approaches to development and marketing (8).

Through single-use/disposable systems, advanced therapeutics/cell and gene therapy technologies, continuous bioprocessing, and other differentiated bioprocessing services, the future of biopharmaceutical CMOs is set to emerge into multiple markets to increase productivity and cut costs (1).

1. BioPlan Associates, BioPlan’s 19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2022, www.bioplanassociates.com/19th.
2. PharmTech Editors, Societal CDMO Signs Multiple CDMO Service Agreements. Press Release. PharmTech.com. October 25, 2022.
3. Terumo Global. Terumo Pharmaceutical Solutions Expands CDMO Services
Outside Japan for Global Market. Press Release. October 31, 2022.
4. Kindeva. Kindeva Drug Delivery Acquisition of iPharma Labs Inc. Press Release.June 16, 2022.
5. Catalent. Catalent Completes Expansion of Clinical Supply Facility in Shanghai, China. Press Release. December 1, 2022.
6. Thermo Fisher Scientific. Thermo FisherScientific Expands its Global Biologicsand Steriles Manufacturing Capabilities in China. Press Release. December 8, 2022.
7. Recipharm. Recipharm Strengthens Pre-filled Syringe and Cartridge Offering with New Investment. Press Release. October 19, 2022.
8. CPHI and Thermo Fisher. The Future of Outsourcing- Strategies for Partner Selection. Press Release. August 2022.

Articles

Features

CMO growth is focused on analytical testing, toxicity testing, and fill/finish operations.

Technology Advances in Outsourcing Services

The coordinated steps required to safeguard biologic medications, vaccines, and personalized cell and gene therapies (CGTs) from the moment they begin the journey from origin to destination are notoriously complex. Many best practices and lessons learned have emerged in recent years as pharma/life sciences companies, along with their third-party logistics partners and vendors that supply specialized packaging and monitoring solutions, have all weathered the COVID-19 pandemic together and continued to support ongoing growth in the pipeline of therapeutic products that must be continuously maintained at refrigerated, frozen, or ultra-frozen temperatures.

There is no room for failure if any of these high-value—and increasingly one-of-a-kind—therapy options are allowed to experience temperature excursions. “Especially when it comes to autologous CGT products, the need to track the shipment from the donor patient to the processing center (laboratory or manufacturing location) and back to the patient is of
paramount importance,” says John Bermudez, vice president, product marketing, TraceLink.

“What really complicates CGT shipping in particular is that these high-stakes shipments must be customized for smaller-sized, highly individualized parcels,” notes Shea Vincent, senior marketing director of BioLife Solutions. “With some of today’s gene therapies priced at $1, $2, or even $3 million, failure is not an option during distribution.”

While the industry has learned a lot during the steep and fast learning curve imposed by the pandemic, and many of the lessons learned are now routinely being applied to optimize the shipment of both larger-volume biologic products and vaccines and smaller-volume CGTs, “the reality is that the tactical implementation of these specialized supply chains for CGT products has yet to be fully established on an industry-wide scale,” says Vivian Berni, director of product management and strategic marketing for Sonoco ThermoSafe. “This leaves a significant burden on manufacturers of today’s cell-based products to distribute their products reliably. Unknowns cause doubt, uncertainty, and risk—and these are not friendly ingredients in a discipline that strives for repetition and predictability.”

“There are already a lot of capabilities in place—experienced cold-chain couriers, state-of-the-art insulated containers, the ability to track and monitor with reliable, cost-effective sensors—so it’s more about pulling the right mix of the elements together in the most strategic and effective way to maximize visibility and minimize the risk,” says Bermudez.

Cold chain planning and execution “… continues to be impacted by not only the pandemic but by other factors, such as air cargo capacity being down, instability related to inflation, the Russia/Ukraine conflict, and more, but despite it all, you still have patients depending on what you’re delivering,” notes Rob Coyle, senior vice president, healthcare strategy, Kuehne+Nagel. As such, he says that stakeholders handling high-end CGT products “need to be really honest about the risks and plan for them ahead of time. Developing a robust backup plan (and having all parties agree to it) ahead of time allows for seamless pivot and rapid response should any delay arise en route.”

For many routes, it makes sense to use passive shipping containers, as they require no power infrastructure, have a more favorable carbon footprint, and can often provide a lower-cost option if appropriate. “With careful planning, we’re often able to replace active shippers with passive units by leveraging existing infrastructure, ongoing advances in insulation materials, phase-change materials (PCM), and container designs, using advanced GPS and other monitoring devices to ensure continuous access to real-time location, temperature, and other data,” adds Scott Ohanesian, senior vice president, commercial operations, QuickStat, a Kuehne+Nagel company.

“Those handling temperature-sensitive pharma products and biologics have experienced a lot of frustration over the past few years due to strategic shortages and supply-chain issues related to dry ice, liquid nitrogen, and the types of specialized packaging that is needed,” says Vincent. “Fortunately, newer materials such as advanced insulation materials and PCMs that continue to come to market are setting up the industry for a better, more reliable future.”

PCMs are engineered materials—based on paraffins, fatty acids, alcohols, hydrated salts, and more—that are conditioned to the refrigerated or frozen setpoint temperature at the outset and placed inside the specialized transportation container. They are able to store and release energy (undergoing a change in phase as they are warmed and cooled) as needed to maintain the critical setpoint temperatures inside the passive thermal containers throughout the trip.

Meanwhile, to ensure dock-to-dock shipping integrity, Vincent says it’s important “to develop a backup plan and to ensure that all stops on the trip have sufficient ultra-low-temperature (ULT) storage capacity, or the ability to access more dry ice or recondition the PCM.” She notes that the planning gets more complicated when the customer will be shipping product by the pallet but then dividing the pallet to repackage smaller volumes to ultimately reach many different destinations.

“The Holy Grail for the pharma cold chain is ‘how do I get perfect service at a more economical price?’” says Dan Gagnon, vice president of global strategy for UPS Healthcare. Economies of scale and tighter overall integration can help to coax out some unnecessary expenditures.

A particular challenge is that the end-to-end distribution of biologics often requires handoffs among multiple partners using disparate systems, and this creates unnecessary complexity. “Today, existing tools can be used to reliably track individual shipments, but the challenge is that it has to be coordinated with actual patients and the labs that process the cells,” notes Bermudez. “The ability to closely coordinate all handoffs improves visibility and gives timely alerts when a shipment has gone out of temperature range or needs intervention.”

In other cases, pharma/life sciences stakeholders producing biologics and CGT products enlist multiple vendors and partners to create complex end-to-end distribution routes. “Stakeholders should choose partners who take a consultative approach,” says Amy DuRoss, president, cell and gene therapies, CSafe Global. “They can help to identify the challenges ahead of time and address them effectively when they do arise.”

In recent years, UPS Healthcare “has made its mission to streamline and integrate the pharma cold chain as much as possible, bringing as much of the end-to-end capabilities—in terms of storage capacity, ocean, ground, and airline networks—in house as possible to maximize quality and visibility,” says Gagnon. “Any time you can remove a handoff between two parties it dramatically reduces the risk of excursion, and our singular, unified system uses the same systems and similar training for all personnel, which provides a complete end-to-end cold chain under one roof.”

In November, UPS Healthcare acquired global healthcare logistics provider Bomi Group, helping to expand its footprint across Europe and Latin America. UPS Healthcare customers now have access to 216 facilities with 17 million square feet of current good manufacturing practice and good distribution practice-compliant healthcare distribution space in 37 countries and territories.

“Scientific advances are always ahead of the regulatory frameworks, so logistics providers need to work closely with regulatory authorities when it comes to CGT distribution,” notes Ohanesian. For example, delays in Customs vary from country to country and can chip away at the limited window for which packages transporting biologics and CGT products is guaranteed to remain at its setpoint temperature. “Customers often make a packaging choice and get locked in, so they don’t really consider qualifying newer packaging options—we see that a lot,” adds Coyle.

For instance, Ohanesian says, “If your quality team has already qualified a particular technology that can ensure the setpoint temperature is maintained for three days, but there exists an option that can maintain it for eight days, you need to consider making the switch.”

“One of the challenges associated with competing technology options is that you need to keep investing in new technology, but you can’t just get distracted by every shiny new technology solution,” adds Gagnon. “You have to critically evaluate which technology advances will bring significant value to customers and focus on which offerings are likely to still be around in the years to come.”

Despite ongoing innovation in supply chain traceability, real-time tracking, and enhanced visibility, DuRoss says, “we urgently need solutions that simplify and standardize CGT operations so that this field can scale. High complexity often translates to higher-than-necessary costs, which results in fewer patients being treated.” To achieve mass adoption within the CGT space, “we need to both industrialize and personalize in parallel,” she continues.

“Having a comprehensive commitment to quality is a winning strategy and putting the systems in place now can save you a lot of headaches later,” says Gagnon.Meanwhile, in all partnerships, specific elements (such as hardware, software, service, and more) must go through consistent qualification and validation processes and be demonstrated as suitable for use in the regulated environment, notes Emanuel Schäpper, head of global business management for ELPRO. Coyle adds, “If you don’t have detailed standard operating procedures (SOP) and quality systems in place, and enforce that each of your partners implement them, too, it will open you up to human and process error.”

“Not all technology, tracking devices, and packaging options work across all networks, locations, or applications,” adds Berni. “Understanding the constraints of each option helps all parties to manage expectations and set things up for success.”

“In response to the COVID pandemic, we developed a passive parcel ULT shipper that can transport and store mRNA [messenger RNA] vaccines at a range of -60 °C to -90 °C for up to 30 days, and it has been used to reliably ship COVID-19 vaccines to 180 countries,” says DuRoss of CSafe Global. “We must leverage all of the global COVID-19 learnings and solutions to enable scaleup in CGT.”

When it comes to container designs, insulation, and PCM materials, monitoring, and control systems and versatile cloud-based solutions to enable greater visibility, stakeholders should keep up with ongoing advances and be willing to embrace best-in-class solutions, rather than becoming locked into a particular solution. “The entire chain is only as strong as its weakest link,” says Schäpper.

Choose monitoring and tracking devices carefully

“From the perspective of a suitable monitoring solution, care must be taken to ensure that the operability of monitoring devices [is] user-friendly and easy to understand, especially in the case of extensive, global distribution networks,” says Schäpper. “The operating elements must be clear, and the display must provide unambiguous information about the status of the product or the measurement parameters.”

Engage logistics partners and vendors as early as possible

“The more we can get critical information earlier in the product lifecycle, the better we can design systems to optimize each of the steps. This has been one of the biggest learnings in recent years,” says Coyle. Similarly, Berni adds, “Involving packaging providers and logistics partners in the discussions early on enables a more cohesive overall strategy. I cannot emphasize this enough; start the conversation early with all of your partners—don’t wait.”

“You can’t adequately support CGT patients worldwide when you have cold chain service centers in just a few locations—for instance, you can’t support and service the distributed global CGT infrastructure if you operate just a few locations in North America and Europe,” says DuRoss.

“More than ever, these two teams—which formerly functioned largely independently of one another—are working hand-in-glove from the earliest phases of drug development, and that’s the way it should be,” says Coyle. “We’re still in the infancy of the era of high-end biopharma and personalized medicine, and while we’re already learned so much, there’s still so much more room for ongoing improvement to minimize the risk of product damage and ensure patient access to these high-value, lifesaving therapies,” says Coyle. As the pharma/life sciences pipeline of biologic therapies, vaccines, state-of-the-art CGTs, and other gene therapies continues to grow, so does the need to push for ongoing innovation in the technologies and practices needed to safeguard them during shipping and storage. 

Suzanne Shelley is contributinng editor for 

There is an evolution in the way technology and best practices are blended to meet cold-chain supply requirements for temperature-sensitive biotherapeutics.

Combining Engineering Ingenuity with Managerial Excellence to Safeguard Biologics

Thermo Fisher Scientific recently announced that it had become a founding sponsor of Momentum Labs, a collaborative laboratory and office space to be located in Alachua, Fla. The venture, spearheaded by Gainesville real estate development firm Concept Companies, is designed to serve as a collaborative space for biotech businesses in the greater Gainesville region.

According to a Jan. 12, 2023 company press release, the north central region of Florida is home to more than 100 life sciences companies, but lacks the flexible growth space to help emerging companies succeed. Momentum Labs is intended to fill this gap, providing life sciences companies the ability to scale up without moving to other markets.

“From a regional and state perspective, Momentum Labs provides critical infrastructure and business development resources to support the growth of life sciences in Florida, giving the ecosystem the opportunity to retain companies rather than losing them to other communities,” said Abhinav Akhoury, vice-president, corporate accounts, Thermo Fisher Scientific, in the release. “Through our sponsorship, Momentum Labs has the ability to provide the latest innovative technologies to high-growth life science companies that are developing tomorrow’s life-changing medicines.”

“It’s challenging for growing companies to stay ahead of their space needs,” said Brian Crawford, CEO, Concept Companies, in the release. “Not only is there a large expense for all the equipment needed, but there are also often extraordinary lead times associated with the acquisition and installation. Partnering with Thermo Fisher Scientific gives us the ability to offer the latest innovative instrumentation and equipment to our members allowing them to leverage their capital for growth.”

News

Thermo Fisher’s sponsorship of Momentum Labs is intended to support biotech businesses in the greater Gainesville region.

Thermo Fisher Scientific Announces Founding Sponsorship of Momentum Labs

Be The Match BioTherapies, a provider of solutions for developing and commercializing cell and gene therapies, in conjunction with the Center for International Blood and Marrow Transplant Research (CIBMTR), is offering expanded clinical research organization (CRO) services. These services are designed to help companies reduce the time required to launch and execute clinical trials.

According to a Jan. 17, 2023 company press release, the new CRO Services provide turn-key solutions, including protocol development and approval oversight, project management, site selection, site start-up, data management, research sample/laboratory coordination, study monitoring, statistical analysis, patient-reported outcomes, and financial administration. Companies also have the option to only choose select services, including data analysis, surveys, site selection and management, and sample management.

The CRO services feature built-out clinical infrastructure, including a single institutional review board, a dedicated data safety monitoring board, master contracts, and 

 compliant software. Customers will also gain a direct link to the CIBMTR outcomes database, consisting of data from more than 575,000 patients.

“Be The Match BioTherapies and its partners have successfully supported bone marrow transplant and cellular therapy clinical trials for nearly 20 years,” said Erin Leckrone, senior director, Clinical Trials, CIBMTR, in the release. “Today, with our formal launch of CIBMTR CRO Services, the expertise and resources honed over decades of work by the leading experts are accessible to small-to-mid-sized biotechnology companies. These services, whether used in whole or as ad hoc support, will accelerate time-to-trial and bridge the transition from research to patients.”

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy

Scientific Laboratory Supplies (SLS), a supplier of laboratory equipment, materials, and supplies based in the United Kingdom, recently announced the acquisition of C&M Scientific, a scientific calibration, maintenance, and validation company also based in the UK.

According to a press release from Jan. 12, 2023, the acquisition aligns with SLS’ strategy of acquiring companies across the UK and Ireland. Operating throughout northern England and Scotland, C&M is fully accredited to ISO 9001, ISO 14001, ISO 45001, and ISO/IEC 17025 certification, and also adheres to Medicines and Healthcare products Regulatory Agency, FDA, and Good Manufacturing Practice standards.

“Our multidisciplinary service and product range combine to provide a complete solution for laboratories across Scotland and the North of England. Joining the SLS Group will help us further extend our reach and expand our product offering,” said Ian Alexander, managing director, C&M Scientific, in the release.

“We are thrilled to welcome C&M Scientific to the ever-growing SLS family,” said Ian Roulstone, managing director, SLS, in the release. “This deal represents another great addition to the SLS Group as C&M Scientific have cultivated a reputation for unrivaled technical expertise.

We are excited to further expand the SLS Group service provision and this acquisition continues our recent focus on developing a world-class service offering.”

Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.

Scientific Laboratory Supplies Acquires C&M Scientific

Nova Biomedical, a life sciences instrument provider, recently announced the launch of the BioProfile FAST CDV, a high-throughput, fully automated viable cell density and viability analyzer. The device uses trypan blue dye exclusion methodology for determination of live and dead cells, as well a high-resolution camera/optics to provide cell density and cell viability measurements.

According to a press release from Jan. 3, 2023, the analyzer is capable of producing results in less than 70 seconds with 100 microliters of sample volume. It also performs all sample dilutions internally, which allows cell culture samples up to 140e⁶ c/mL to be analyzed without external sample dilution. The device can sample cell cultures via an external 36-position loans-and-go tray or via a 96-well plate option.

The software associated with the device has a built-in touch screen display and icon-based navigation. Its software and networking capabilities are 

 compliant and have also been designed to meet FDA’s new cybersecurity guidelines.

“We at Nova Biomedical are excited to launch the next addition to the BioProfile platform with the FAST CDV Analyzer,” said Matt McRae, Biotechnology Sales Product line manager, Nova, in the release. “The FAST CDV is a significant advance in automated cell density analyzers and breaks the boundaries of existing technologies. It will enable even faster evaluation of cell lines and physicochemical parameter optimization, ultimately bringing products to market faster.”

New Technology

The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.

Nova Biomedical Launches Cell Density and Viability Analyzer

Pfizer and Gero, a Singapore-based preclinical-stage physics-enabled biotechnology company, have entered into a research collaboration in which Pfizer will apply Gero’s machine learning technology platform to discover potential therapeutic targets for fibrotic diseases. The collaboration will use large-scale human-based data.

Under the agreement, Gero will receive an upfront payment. The company is also eligible to receive discovery milestone payments if the project progresses. The collaboration will leverage Pfizer's expertise and Gero’s technology platform to identify genes and pathways that are linked to fibrotic diseases. Pfizer may advance the potential therapeutic targets and would be responsible for any further preclinical and clinical development.

“Human data-driven drug discovery avoids the ‘preclinical trap’ and has the potential to identify clinically relevant targets against human (not rodent) diseases. However, genetics-based target identification against age-related diseases is hindered by the irreversible component of human aging,” said Peter Fedichev, CEO of Gero, in a Jan.6, 2023 company press release. “Our technology platform allows us to separate irreversible effects of aging from reversible disease phenotypes to potentially identify the most actionable therapeutic targets.”

“We are excited to work with Pfizer … to potentially identify targets against fibrotic diseases, which have a large unmet need. We believe that combining our platform technology with Pfizer’s extensive disease expertise has the potential to identify high-value targets in this disease area,” said Alex Kadet, chief business officer, Gero, in the release.

Pfizer and Gero have partnered to discover potential therapeutic targets for fibrotic diseases using machine learning technology.

Pfizer and Gero Form Collaboration to Discover Potential Targets for Fibrotic Diseases

AbbVie and US-based Anima Biotech (Anima) have formed a collaboration to discover and develop messenger RNA (mRNA) biology modulators for three targets across oncology and immunology. In the collaboration, Anima will use its mRNA Lightning technology platform to discover novel mRNA biology modulators against the collaboration targets. The company will provide AbbVie exclusive rights to license and further develop and commercialize these programs, according to a Jan. 10, 2023 company press release.

Under the agreement, Anima receives $42 million in an upfront payment and may be eligible to receive up to $540 million in option fees and R&D milestones in the aggregate across the three targets. The company will also have the potential to receive further commercial milestones and tiered royalties on net sales. AbbVie has an option to expand the collaboration with up to three additional targets under the same terms as the initial collaboration, which may increase the potential value of the collaboration.

"This collaboration will give AbbVie access to Anima's leading technology platform and deep expertise in mRNA biology and will help further strengthen AbbVie's [capabilities] in discovering and developing drugs to make a difference in patient[s’] lives," said Jonathon Sedgwick, vice-president and global head of discovery research, AbbVie, in the press release. "Modulating mRNA biology with small molecules is a new approach and has the potential to address 'undruggable' targets with implications across multiple therapy areas."

"Anima's differentiated approach in the field of small-molecule mRNA drugs combines phenotypic screening with AI [artificial intelligence]-driven elucidation of the mechanisms of action. The power of our mRNA Lightning platform is validated by our multiple partnerships and a growing internal pipeline," said Yochi Slonim, co-founder and chief executive officer, Anima, in the release.

The collaboration between AbbVie and Anima Biotech will combine Anima's mRNA Lightning technology platform with AbbVie's extensive expertise in oncology and immunology.

AbbVie and Anima Biotech Partner on Discovery and Development of mRNA Biology Modulators

Boehringer Ingelheim and 3T Biosciences announced on Jan. 13, 2023 that they have entered into a strategic collaboration and licensing agreement to discover and develop next-generation cancer therapies to address high unmet patient needs.

The partnership is meant to unite 3T Biosciences’ best-in-class 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform with Boehringer Ingelheim’s two-pronged research strategy combining cancer cell-directed and immune cell-targeting compounds, further strengthening the pipeline.

The platform from 3T platform aims to address this challenge by identifying novel shared T-cell receptor (TCR) targets of productive immune responses and comprehensively screening TCRs and TCR mimetics for specificity and off-target cross-reactivities. It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning. This could lead to tumor-specific, safer therapies that can be delivered at high doses.

“At Boehringer Ingelheim, we are committed to transforming patients’ lives. Through our new partnership with 3T Biosciences, we aim at accelerating and expanding our pipeline of first-in-class T-cell based therapies for patients affected by cancer,” said Lamine Mbow, PhD, global head of Cancer Immunology + Immune Modulation, Boehringer Ingelheim, in a press release.

Stefan J. Scherer, MD, PhD, president and CEO of 3T Biosciences, added that 3T’s 3T-TRACE discovery platform has the potential to transform the treatment of cancers and beyond. “By using data from patients for patients we aim to discover the best immunogenic targets for multiple tumor indications and across patient populations,” he said in a press release.

The agreement notes that Boehringer Ingelheim will provide patient-derived TCR data to fuel 3T’s target discovery efforts to identify antigens using its 3T TRACE discovery platform. Additionally, 3T will receive an upfront payment and research and development support, while still being eligible for discovery, preclinical, clinical, regulatory, and commercial milestones for a total of $268 million and royalties on future Boehringer Ingelheim product sales.

It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning.

BioPharm International's BP Elements, February 2023