WuXiUI applies an intermittent-perfusion fed-batch (UI-IPFB) strategy in upstream production to realize a three- to six-fold increase in productivity in a typical culture duration of 14 days for a fed-batch process for different molecule modalities such as monoclonals, bispecifics, and recombinant proteins, according to Chris Chen, PhD, company CEO. For example, by leveraging WuXiUI, the titer of a bispecific antibody achieved 25 g/L in 14 days (five times higher than the same-scale traditional fed-batch process), he added.

“WuXiUI reduces drug substance manufacturing COGS by an estimated 60–80 percent compared to traditional fed-batch processes in single-use bioreactors, enhancing the competitiveness of commercial products,” continues Chen. “The platform is also easily adopted and can be scaled up/out in existing facilities without additional requirements for major equipment or complex operations, bringing minimum changes to the downstream process. Adhering to WuXi Biologics’ ESG (environmental, social, governance) strategy, WuXiUI has a lower carbon footprint than traditional or other intensified fed-batch processes due to more efficient media consumption and reduced waste generation.”

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Producing living cells as a therapeutic product is a complex process. To date, autologous-based cells comprise the majority of clinically-evaluated CAR T-cell products. Although autologous therapies can indeed be effective and life-changing for patients, this approach poses time and logistics constraints. Allogeneic cell products, generated using cells from healthy donors, can potentially overcome these limitations and provide the generation of “off-the-shelf” products.

But the technologies, solutions, and equipment needed to bring allogeneic cell therapies to large-scale clinical trials and global commercialization are not yet commercially available and that is, besides the biological challenge to guarantee immune evasion of these cells, one of the key bottlenecks facing the industry.

To capture the potential of using healthy donor stem cells as the basis for cell therapies, cells must be programmed in a way to avoid attack by the recipient’s immune system. Recent developments in gene editing technologies support strategies to design immune evasion.

“So now, we have the basis for moving from a single-patient autologous therapy to a one-to-many allogeneic therapy. However, we need the technologies, solutions, and equipment to make that possible,” pointed out Aaron Dulgar-Tulloch, PhD, chief technology officer, Cytiva. Cytiva and Bayer share a vision and common view of the challenges limiting the advancement of allogeneic cell therapy and believe that together they can overcome these challenges.

The companies are collaborating to build a fully-automated, modular platform that can be utilized for scaleup and manufacturing of multiple cell therapy products. The concept will use fully-characterized individual equipment modules that can be incorporated in a plug-and-play scenario. Both Dulgar-Tulloch and Bieringer believe this will accelerate the learning curve.

Human cells are fragile

Dealing with living cells as a therapeutic product makes the processes more complex than traditional biotherapeutics. Depending on the therapeutic application, different types of cells must be processed. These cells, which may need to be grown as aggregates, cell suspensions, or single cells, show higher sheer and nutrient and waste sensitivity relative to classical bioproduction cell lines.

In essence, the cells want to “feel good” in the corresponding reactors, which means that they require the right media composition. In addition, oxygen transfer and metabolic stress need to be precisely controlled. To provide the cells the optimal environment both the underlying biological process and the equipment performance must be optimized.

Enabling genomic medicines

The collaboration is focused on what the companies envision the entire genomic medicine field needs to bring cell therapies to patients faster. “If we are successful, we believe the entire community of therapy developers, technology providers and most importantly, patients, will benefit from accelerated, cost-effective, and globally available, allogeneic cell therapies,” said Dulgar-Tulloch.

The process began by aligning on the boundary conditions of the platform, i.e., the way to define the modularity (hardware and software plug-and-play), the automation and the process control concept. The initial focus is on two components with a current immense need: a 3D expansion system for production at scale and a robust harvest solution. As additional needs are identified other devices may follow.

The ultimate goal is to gather insights and offer solutions to a wide range of users driving the creation of an allogeneic cell therapy consensus platform. Bieringer emphasized that this will drive economies of scale and simplify global manufacturing, ultimately driving down costs to make allogeneic cell therapies more accessible.

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As bioprocessing moves forward, companies hope to keep better track of production. A key goal is in-line analysis. This “enables continuous monitoring and control of critical process parameters in upstream bioprocess development,” says Chris Brown, PhD, co-founder and chief product officer at 908 Devices. “In-line measurements of cell cultures occur directly in a bioreactor with no sample volume loss.”

As a result, in-line analysis provides many benefits. Brown mentions sample integrity, preserving costly media, reducing waste and contamination risk, and improving product quality. “In-line analysis also saves operator time compared to manual sampling, which is labor intensive,” Brown says.

In addition, in-line analysis allows bioprocessors to improve the control of production. As Brown notes, this form of analysis “provides real-time monitoring of a process, allowing for immediate corrective action to be taken along with rich data to better support efforts in predictive bioprocess modeling.”

Challenges remain

Nonetheless, challenges stand in the way of reaching that goal. “As the biopharmaceutical industry adopts process analytical technology—PAT—to drive the advancement of Biopharma 4.0, scientists need an array of tools that provide timely measurements of critical process and product quality attributes,” Brown says.

For now, scientists need better tools to accomplish these goals. “The power of Raman spectroscopy for in-line bioprocess analysis is well known, but the expense and expertise required to develop robust and sustainable multivariate models is a massive impediment,” Brown says. “For Biopharma 4.0 to advance, scientists need a suite of devices that offer easy-to-integrate in-line analysis and control without the need for substantial expert configuration.”

Fortunately, existing technology can address the challenges and realize the potential of in-line analysis.

“There are solutions available now that can offer all the advantages of Raman spectroscopy without the cost and complexities associated with conventional spectroscopic methods,” Brown says. “These are turn-key solutions that provide real-time, in-line monitoring and control of multiple bioprocess parameters with no modeling or development required.”

This approach relies on “purpose-built de novo models that automatically process Raman spectra from a wide variety of cell culture media types and cell lines, delivering actionable process parameters in minutes,” Brown says.

Overall, in-line analysis could transform much of bioprocessing. As Brown sums it up: “In-line analyzers enable biopharmaceutical process development scientists and manufacturers to enhance process understanding and implement dynamic control strategies quicker and easier.”

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Making autologous cell therapies is a logistical challenge as much as a technical one. Material from the hospitalized patient must be transferred to a facility for processing before being returned for administration, all of which takes time and costs money.

In-hospital production is emerging as a viable alternative, which suggests a new generation of automated cell processing technologies could simplify and reduce the cost of making these innovative cures.

Stephan Kadauke, MD, PhD, assistant professor of clinical pathology and laboratory medicine at the University of Pennsylvania’s Perelman School of Medicine, calls these bedside, automated cell processing systems, “GMP-in-a-box.”

“Good manufacturing practice in a box essentially condenses the complex cell therapy manufacturing process into a more compact and automated system that can be housed within a hospital,” he says. “This not only automates an error-prone manual process but also eliminates the need to send cellular materials to centralized manufacturing facilities. We found that this can reduce the cost associated with delivery of novel cell therapies like CAR-T cells to patients. So the advantage is not just in cost, speed, and quality control, but also in patient access.”

Minimizing operator handling

In the study, Kadauke and co-authors looked at a range of in-hospital cell therapy production technologies and found that, although the platforms differ, all of them are designed to link multiple production steps while minimizing operator handling.

“The currently available systems involve a variety of technologies that handle cell selection, culturing, and quality control. Automation plays a significant role in these processes,” he points out. “The goal is to create a ‘one-stop-shop’ for producing cell therapies. The two most mature platforms are the Miltenyi CliniMACS Prodigy and the Lonza Cocoon. However, others are coming.”

Demand for these systems is likely to increase as healthcare professionals seek to improve access to cell therapies, according to Kadauke.

“In-hospital manufacturing is still relatively novel but is gaining traction. A few pioneering hospitals have already implemented such systems, and we expect to see more widespread adoption as the technology matures, especially in parts of the world that currently do not have access to these therapies.”

In addition, Kadauke predicts biopharmaceutical manufacturers will be interested in GMP-in-a-box systems.

“Biopharmaceutical companies also take advantage of GMP-in-a-Box systems to benefit from cost savings due to automation and standardized workflows, though our article focused on in-hospital applications,” he tells GEN. “A large wave of commercial cell therapy products is expected to hit the market in the next year or so, and products manufactured in-hospital with GMP-in-a-box systems will complement and coexist with current and novel commercial cell therapies.”

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Although water’s shear viscosity is important in accurate molecular dynamics modeling, the results from two popular water models differ from those of actual experiments by as much as 20%. In a recent paper, Tadashi Ando, PhD, associate professor at Tokyo University of Science, compared shear viscosity predictions for the four-point Optimal Point Charge (OPC) and three-point OPC (OPC3) models with results from physical experiments. Temperatures ranged from 273°K to 373°K.

Water viscosity for the OPC and OPC3 water models has not been reported in the literature previously. Yet, they are important when evaluating molecules’ self-diffusion coefficients in an infinite system in comparison to molecular dynamic simulations.

Detailing the results in The Journal of Chemical Physics, Ando reported the OPC and OPC3 models were accurate for temperatures above 310°K. Below that, they “systematically underestimated the shear viscosity.” At temperatures of 273°K and 298°K, the calculated viscosities were, respectively, 20% and 10% lower than the experimental values.

Significantly more accurate

Overall, Ando found OPC and OPC3 were significantly more accurate than other popular water models, such as Transferable Intermolecular Potential three-point (TIP3P) or extended Simple Point Charge (SPC/E) models. Other water models—specifically the TIP4P/2005, TIP4P-FB, and TIP3P-FB—predicted shear viscosity more accurately at temperatures below 293°K.

Knowing viscosity differences between models and the actual experiments is important, Ando tells GEN. “Most drugs and biological molecules, such as proteins, DNA, and polysaccharides, exist in an aqueous environment. The presence of water molecules around these molecules significantly affects their dynamics and interactions. Therefore, developing more accurate water models and their quality assessments are also important for successful biomolecular simulations and in silico drug design.”

The OPC and OPC3 water models are “among the best nonpolarizable water models, accounting for the various static and dynamic properties of water,” he says. However, “Most biomolecular models and their force fields have been developed with older water models. Therefore, simply using the OPC/OPC3 water models with many of the existing biomolecular force fields would not yield satisfactory results.”

Improvements are available. “Recently,” Ando says “AMBER, a well-known molecular simulation software and biomolecular force fields developer, developed a protein force field whose performance is improved by using the OPC water model.” Additional biomolecular force fields are likely to be developed with OPC water models to yield more accurate biomolecular simulations.

Ando’s paper may not have a profound, immediate impact on the industry, he says. Instead, it enables deeper understanding of several of the most popular water models so biopharmaceutical manufacturers can select the most appropriate for their biomolecular simulations.

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Analytical techniques for cell counting and surface marker analyses are improving to meet the needs of cell therapy developers; That’s the view of Lara Silverman, PhD, principal consultant at LIS BioConsulting.

According to Silverman, the growth in advanced therapies is leading to analytical techniques for cell counting beyond, for example, the hemocytometer.

“The analytical space was stagnant, but it’s starting to change because of developments in the bioprocessing world,” Silverman explains. “It’s no longer enough to take the binary approach of knowing if cells are alive or dead. You need to know what cells are doing and how they’re responding to a process.”

Companies might need to know whether cells are metabolically active, alive but no longer expressing a therapeutic marker, or alive but in apotheosis. Although the field is developing techniques for cell counting and identifying surface markers, Silverman says there’s still a delay in the development of new potency assays.

“That might be the reality of our industry [… as] a lot of companies keep their potency assays private because they take so long to develop,” she continues. “But there aren’t yet any ground-breaking discoveries or companies that can consistently support a diverse array of potency assays to streamline [analytics for therapy developers].”

Understanding process deviations

Going forwards, Silverman sees in-process analytics and artificial intelligence as helping to better understand process deviations, reducing the number of failed lots.

“It will require the integration of a tremendous amount of data and analytics, especially for treatments that are lifesaving, such as CAR-T, where the patient may die if they don’t receive the product,” she says.

Analytics could also be used to personalize medicines to the characteristics of the patient, although Silverman believes this may be some time away. “It’s really exciting, but I think the industry is a little scared to dip their toes into it because advanced therapy manufacturers are already challenging the FDA with their drug products.”

Silverman also sees new analytical instruments, such as the Accellix benchtop flow cytometer, as aiding the trend towards decentralized manufacturing.

“Flow cytometry has changed little in many decades. It’s extremely time-consuming and requires manual handling,” she says. “With the Accellix system, you just load your cells into a plastic cartridge that has a specific set of surface markers associated with it, and pop it into a tiny machine, so it’s something that could go on the manufacturing floor rather than in a QC lab.”

Silverman also thinks other instruments, such as the Dynex system for fully-automated ELISA testing, could aid decentralized manufacturing by reducing human error between testing sites. 

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Broadcast Date: November 3, 2023
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

Hydrogen/deuterium exchange coupled to mass spectrometry (HX-MS) is a valuable technique for analyzing the structural features and dynamic properties of individual proteins and large protein complexes. HX-MS can be used to study a wide range of structural properties including protein folding, ligand binding and allostery, and epitope mapping in the development of therapeutic antibodies. However, HX-MS is not routinely used in protein structure analysis because of data analysis challenges that limit its throughput and scope.  

In this GEN webinar, Dr. David Schriemer, University of Calgary, will present an innovative approach for applying HX-MS to protein analysis in biotherapeutics development. He will demonstrate a data independent acquisition-based HX-MS workflow that significantly reduces analysis times, enables the study of larger datasets, and paves the way for a standardized strategy for protein structure analysis. Dr. Schriemer will show how HX-MS can rapidly characterize drug-binding interactions using a 500-kDa mammalian kinase using affinity pulldowns.  

Key takeaways from the webinar include:

• Discovering the latest MS advances that benefit HX-MS technology.
• Learning about the implementation of data-independent acquisition for HX-MS.
• Learning how to use HX-MS to study drug binding interactions and higher-order protein structure dynamics.
• Understanding the data mining approach used to confirm peptide ID and authenticate, or even correct, MS1-based deuteration calculations.

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelist.

Produced with support from:

David Schriemer, PhD
Professor
University of Calgary

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Broadcast Date: October 31, 2023
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

Gene therapies are maturing rapidly with an increasing number of these treatments gaining regulatory approval in recent years. Viral vectors, such as adeno-associated viruses (AAVs), have emerged as one of the most used gene delivery vehicles in many disease contexts. Their unique features make them suitable vectors for in vivo gene therapies for various conditions including ophthalmological, metabolic, hematological, and neurological diseases.

In this GEN webinar, our expert speakers will discuss strategies and tools for designing optimal viral vectors for gene therapy delivery. They will present an integrated platform designed to support the discovery stages of a viral gene therapy program. During the webinar, you’ll learn:

• How WuXi AppTec can help to engineer and optimize viral vectors, including rationalized promoter design and transcription unit optimization.

• Fast, scalable, cost-effective viral vector production methods using industry standard transient transfection, packaging cell lines, and the novel TESSA technology.

• How to utilize a range of in vitro and in vivo assays for efficacy and safety evaluation.

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists.

Webinar produced with support from:

The post AAV Gene Therapy Discovery and Optimization appeared first on GEN - Genetic Engineering and Biotechnology News.

The 41,000-ft²-site will produce cGMP cell and gene therapy reagents, including single guide RNAs (sgRNAs) and donor oligos for homology-directed repair (HDR) with additional offerings to follow. These new capabilities and offerings will be supported with comprehensive documentation and testing, a support team, and regulatory guidance to help accelerate researchers’ path to the clinic, according to Demaris Mills, president of IDT.

“An increasing number of customers are seeking out IDT as a trusted partner for their CRISPR genome editing needs and are asking us to be the provider that can help them bridge the gap from lab to clinic,” said Mills. “Now, with our new cGMP manufacturing facility, IDT can provide a complete CRISPR workflow—from design to analysis—that supports cell and gene therapy developers in all stages of therapeutic development, with the same support and expertise they have come to know from IDT. These new manufacturing capabilities, which have been informed by our decades of oligonucleotide synthesis manufacturing expertise, evolves IDT’s business model from Research Use Only to cGMP, and enables us to help more people.”

“The future of genomic medicine hinges on the industrialization of biology to make life-saving therapies more accessible to people,” added Chris Riley, Danaher VP and group executive. “As a pioneer in genome editing, IDT’s continued investments will enable customers to rapidly move from clinical development to commercialization. This new facility is another significant milestone in IDT’s innovation journey, one we envision will have a profound impact in genomic medicine for years to come.”

The therapeutic oligo manufacturing facility features ISO 8 cleanrooms, purification suites, chemical distribution and storage rooms, quality control labs, analytical lab space for product testing, ancillary and office spaces, and shell space for future expansion. Manufacturing is performed in accordance with ICH Q7 cGMP standards for consistent and reliable quality. The controlled-access building features environmental controls for temperature, humidity, and air pressure throughout, supported by an environmental program and continuous monitoring system

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Carlsbad, CA—The timing of the Cell & Gene Meeting on the Mesa appears to have been prearranged with the help of a crystal ball. Members of the cell and gene therapy field are anxiously awaiting the FDA’s review of three submissions before the end of 2023: two treatments for sickle cell disease—exa-cel (Vertex and CRISPR Therapeutics) and lovo-cel (Bluebird)—as well as Bristol Myers Squibb and 2Seventy Bio’s Abecma for earlier multiple myeloma.

The sector is at an inflection point. There’s a lot of excellent science and exciting clinical results. Still, it remains to be seen whether that will translate into commercial success—a major focus of this week’s Alliance for Regenerative Medicine (ARM) conference. 

Regulatory approval

All eyes, therefore, are on Nicole Verdun, MD, the new permanent director of the FDA’s Office of Therapeutic Products (OTC), which is within the Center for Biologics Evaluation and Research (CBER). Verdun’s plate has a healthy serving of cell and gene therapy clinical trials for rare and serious diseases, which typically do not fit the testing paradigm of a randomized clinical trial. According to Verdun, who will be working hand in hand with CBER director Peter Marks, MD, PhD, the key to the approval of cell and gene therapies for conditions with just a handful of patients is a mix of communication and regulatory flexibility.

“We have INDs open for diseases where there are 11 patients in the United States,” said Verdun. “There needs to be increased communication earlier on in the development process, and there has to be consideration for the disease, the benefit-risk for how rare it is, and we have to do what we can to partner to get more of these therapies to patients that need them.”

To get right at this, Verdun highlighted the “Support for clinical Trials Advancing Rare disease Therapeutics” (START) Pilot Program. Three chosen START participants must be sponsors of cell and gene therapies for rare diseases and serious conditions currently in clinical trials under an active Investigational New Drug Application (IND). These participants will be able to receive regular advice and ad hoc communication with FDA staff to talk about product-specific development issues, such as clinical study design, choice of the control group, and fine-tuning the choice of the patient population. START will begin accepting applications between January 2 and March 1, 2024. 

Manufacturing and commercialization

 As more cell and gene therapies begin to move into the clinic, there is growing attention on manufacturing, which may be the major bottleneck for creating commercialized products.

Automation and artificial intelligence (AI) will be major disruptors to the manufacturing and commercializing cell and gene therapy. The efforts made by Cellares with its Cell Shuttle to integrate batch processing and automation into the assembly process serve as evidence of this. But automation and AI will not be enough.

According to Ann Lee, PhD, chief technical officer at Prime Medicine, there are three key factors to developing commercial-grade manufacturing. The first is picking the right people, because getting a cell and gene therapy program into the clinic requires a breadth of expertise that will likely not be found in a single individual. The second is data infrastructure, because to generate data that will be submitted for an IND or BLA submission, processes need to be in place where it is retrievable, tracked, and analyzed. Third, Lee said that regardless of going the internal or external route, the process needs to be transparent because no cell or gene therapy will be approved if the manufacturing process is a black box.

Some key factors go into choosing to partner with an external CDMO for manufacturing or bringing it in-house, often touted as the best way to control one’s destiny. While many have approached the manufacturing of cell and gene therapies with the view to putting all their manufacturing capabilities into the hands of partner CDMOs, some have decided to take this on to various degrees to gain increased control of their medicine’s destiny.

For cell therapies, some of this may come down to whether a company’s approach uses allogeneic or autologous cells. Sumit Verma, senior vice president of Global Strategic Manufacturing at Iovance Biotherapeutics, said that, while there is a lot of allogeneic work being done and CAR T having that success rate, autologous cell therapy has its place as a potentially unrivaled personalized medicine but is incredibly challenging from a logistics side. “For the patient’s benefit, being able to manufacture [an autologous cell therapy] batch is a key concept that I think you’re going to see a lot more maturity next year,” said Verma.

With two autologous cell therapy, using patient-specific tumor-infiltrating lymphocytes and peripheral blood lymphocytes (PBL), Iovance has taken an approach to investing in both their own manufacturing capabilities, as evidenced by their recent investment in establishing the Iovance Cell Therapy Center (iCTC)—a 136,000-square-foot facility in Philadelphia.

While Intellia Therapeutics will also be opening a new manufacturing facility in Waltham, Massachusetts, in 2024, chief business officer Derek Hicks said that in this market environment, he wouldn’t be surprised if there are more deals featuring a shared partnership between manufacturing and smaller biotechs.

“When you think about manufacturing, it’s not just that shared risk,” said Hicks. “It is how can you work with someone that actually helps you accelerate because we’re trying to get these products to patients. The research is moving very quickly, so how do you ensure that manufacturing doesn’t stop you from bringing things forward? These are the things that we all need to think about.”

Healthcare systems

Bob Smith, senior vice president of the Global Gene Therapy Business at Pfizer, said a lot of his concern for getting cell and gene therapies commercialized is related to the healthcare systems in the U.S. and abroad.

“A lot of healthcare systems have a negative innovation bias in the way that they evaluate and value the innovations that our sector is developing,” said Smith. “No individual company is going to be able to overcome this, and I think we need to think about how we communicate not just with the healthcare systems and how they evaluate not just the regulatory aspects, but now really the value of what we’re bringing to patients.”

For example, Smith points to some European markets where sometimes there isn’t a price approval for a year and a half after the regulatory approval.

“Think about the burden that is on small midsize companies that don’t have a balance sheet like [Pfizer does],” said Smith. “We can absorb that financial hit, but it’s going to put a tremendous financial strain on capital-intensive companies, and we need to really think through how we can change that paradigm to be much more efficient, principally for the benefit of patients but also, quite frankly, for the sustainability of the sector.”

Phil Cyr, senior vice president at Precision Value & Health, said that historically, a lot of payers and health technology organizations have been very focused on cost-effectiveness, but that they’ll also be looking at the budget impact and affordability, especially as cell and gene therapy begin to move into more prevalent diseases, which he believes will happen. Cyr thinks that the way to overcome this is by developing an evidence base to discourage people from thinking about sticker price and more towards long-term value.

“How do you go to a payer with a three to four-year window and make them understand that [gene therapy] will benefit them?” said Cyr. “I can think of one payer that actually built a model to figure out how long they needed to keep that member in their plan to recoup the money.”

For these reasons, organizations like Express Scripts and Cigna’s Embarc will play a key role in the future of gene therapies by helping protect customers from the high cost of gene therapy drugs and ensure access for those who need them.

 Expectations for 2024

Much is riding on the cell and gene therapy submissions that are due to be reviewed by the FDA before the end of this year. If they are successful, its possible that there will be a change in sentiment within the investor community—not to mention patients.

Next year, the Cell and Gene Therapy Meeting on the Mesa will move to Phoenix, Arizona, as the conference has maxed out its current capacity at the Park Hyatt Aviara Resort in northern San Diego. If the FDA approves these initial submissions, the new venue will likely be filled in 2024. But what if they’re not approved? All it takes is one bad batch that will reflect poorly on the entire industry.

As regulatory submissions and clinical data trickle in, there has to be a high standard. But standardization will not be achievable by a single business entity or the FDA alone. This new and evolving field will require organizations like ARM to unite different voices. That’s exactly what’s happening right now at the Cell and Gene Meeting on the Mesa.

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