The science surrounding stem cells dates back over a century, but their clinical applications are relatively young. While stem cell therapy and regenerative medicine hold immense promise, the field remains vulnerable to misinformation, pseudoscience and bad actors who exploit hope without ensuring safety or delivering results. As these treatments gain popularity in wellness circles, the gap between public perception and clinical reality widens. Auragens bridges that gap by anchoring its work in hard science, rigorous ethics and irrefutable outcomes. As a world leader in stem cell therapy, research and cellular medicine, it has a straightforward goal of protecting and elevating the standard of care in regenerative medicine. The company has made a name for itself with its scientific advancements and commitment to transparency, safety and ethical practices. Unlike many competitors, Auragens focuses on a holistic approach to regenerative medicine, providing patients with the care, results and peace of mind they deserve. “There’s no place for guesswork in medicine. We focus on what’s proven, measurable, and what truly benefits our patients,” says Dr. Daniel S. Briggs, president. A leader in regenerative medicine, Dr. Briggs firmly believes that stem cell therapy should be driven by science, not trends. This philosophy is reflected in Auragens’ operational methods, from an on-site laboratory to the extensive safety measures it takes with every patient. Its robust scientific framework focuses on producing measurable outcomes. It works to perfect the use of stem cells, ensuring they’re well-sourced, carefully processed and applied with the highest standards of care.
Life Science Testing
Operating from a sprawling 12,000-square-foot facility in Riverdale, New Jersey, PDA Laboratories is a premier third-party partner for microbiology and analytical sample testing across North America. What began in 2011 as a humble 2,500-square-foot operation has become an indispensable resource to cosmetics, nutraceuticals, and pharmaceutical manufacturers navigating complex product formulations and evolving regulatory landscapes. Every phase of PDA’s journey radiates its founder’s commitment to meeting scientific standards and delivering the market-responsive agility that modern manufacturers demand. Its reputation is not the result of marketing slogans, but of years spent troubleshooting real-world production challenges, turning laboratory analysis into a critical instrument for decision-making where public safety and brand integrity intersect. Its reputation is hard-earned. Manufacturers and packagers depend on PDA not just to release compliant batches, but to avert costly errors, recalls, and the risk of consumer harm. “We make sure that formulas are safe, the products are clean, and that there are no pathogens that could harm the end client or ruin the product,” says James Seijas, VP Operations, substantiating its position in the market. This ethos is reiterated in every technical protocol. The laboratory’s microbiology services include USP , and plate counts, yeast and mold enumeration, and targeted pathogen detection. PDA also specializes in preservative effectiveness testing PCPC (PET) and antimicrobial effectiveness testing USP (AET), which are critical for ensuring product safety. Beyond routine analysis, it conducts microbial identifications and comprehensive facility assessments, supporting clients with environmental air and surface sampling, aseptic validation on production lines, and raw material evaluations to prevent contamination before it compromises product quality. Stability study programs are also offered, customizing accelerated and real-time conditions with microbiology and analytical testing at designated intervals. Formal OOS (out of specification reports) are available upon request as well. PDA Laboratories’ analytical division provides advanced solutions like viscosity, assays, organoleptic attributes, pH levels, high-performance liquid chromatography (HPLC), gas chromatography (GC), and specialized testing for regulated impurities such as benzene, and 1,4-dioxane. The analytical lab also specializes in sunscreen actives testing. Recent capital investments have enabled in-house ICP-MS to quantify heavy metals and total organic carbon (TOC) for water analysis, transitioning services once outsourced to rapid, internal processes with stronger data integrity. Method verifications and validations ensure every report is defensible and compliant..
Cell and Gene Therapy
ViaCord has been a trusted name in the cord blood banking space for over 30 years, offering families a unique opportunity to safeguard their children’s future health. As part of Revvity, a publicly traded company focused on life sciences and diagnostics, ViaCord offers cord blood and tissue banking services. Additionally, the company provides trusted genomic solutions, ensuring families are equipped with the tools to make informed health decisions today and in the future. ViaCord’s approach is deeply rooted in empathy and customer care. Robert Gendron, VP and general manager, says, “Whether it’s a customer educator that personally delivers a collection kit or lab techs conducting individual tests, we treat each cord blood sample with the utmost respect and sensitivity, knowing that each family cares deeply about their children’s stem cells.” This customer-centric philosophy shines through in every aspect of ViaCord’s operations. The company recognizes the challenges that families face, from last-minute decisions to bank cord blood, to unexpected diagnoses. With its extensive experience in the field, ViaCord has protocols in place to handle a wide range of situations, ensuring that each family feels cared for and heard. Customers have used stem cells banked by ViaCord to help treat a wide variety of conditions through transplants or regenerative medicine clinical trials. Today, nearly 80 conditions can use cord blood stems cells to regenerate a healthy blood and immune system, including cancers, blood disorders, and metabolic disorders. Although most conditions are inherited genetic diseases, likely requiring sibling or donor cells, a child’s own cord blood may also be used in certain cases. The field also continues to evolve, providing banking customers with scientific potential into the future. A powerful example of ViaCord’s impact is the story of Rosalia, a young girl who was diagnosed with Acute Lymphoblastic Leukemia shortly after birth. Despite undergoing conventional treatments and going into remission, her cancer returned. Fortunately, her family had banked the cord blood of her younger sister, Holly, through ViaCord. When Rosalia’s medical team struggled to find a match for a bone marrow transplant, it was discovered that Holly’s stored stem cells were a perfect match. The stem cells from Holly’s cord blood were successfully used in Rosalia’s treatment, contributing to her continued remission today. This story highlights the unexpected but life-changing difference that cord blood banking can make, even when families do not initially anticipate needing it..
Regulatory and Compliance
Aroga Biosciences is built to ease the journey of biotech and pharmaceutical companies from development through regulatory approval of novel therapeutics. It is a provider of high-quality medical writing, quality control (QC), and Regulatory Operations (publishing and submissions). These services, all available under one roof, enable life sciences sponsors to reduce dependency on multiple vendors and freelancers, simplifying the outsourcing process. True to its name, “Aroga”, which means “free from disease”, the firm contributes to enhanced health outcomes by aiding the advancement of science and medicine. It covers a broad range of therapeutic areas such as rare diseases and neurology, with a particular strength in oncology. The team additionally has expertise in the unique regulatory landscape of cell and gene therapy as well as combination products that incorporate both biological and device components. The writing and QC teams are comprised of seasoned scientists with advanced degrees in the life sciences, medicine, and pharmacy. Their ability to translate complex scientific content into clear, impactful messaging with consistent quality and accountability has made Aroga a trusted partner in regulatory communications. “Our scientific expertise allows us to ensure technical accuracy and craft narratives that clearly convey the rationale and impact of the medical data, making a difference in regulatory review,” says Dr. Krithi Rao Bindal, president and founder. .
Therapeutics
In 2012, Hurricane Sandy flooded Manhattan and knocked out power to the medical research facilities, killing nearly every lab mouse—except for one genetically modified adenosine receptor knockout group of mice. Among the survivors, the males were unable to breed and struggled to grasp food by 3 months of age. Subsequent investigations revealed that this was due to the spontaneous development of osteoarthritis in those mice lacking adenosine receptors. Digging deeper, scientists discovered that chronic deficiency of extracellular adenosine, a critical cellular messenger, leads to the development of osteoarthritis in mice and rats. In a bold intervention, they packaged adenosine into liposomes—tiny, biocompatible fat spheres—and injected them directly into the joints. In just weeks, the mice and rats with osteoarthritis moved freely and behaved indistinguishably from healthy controls. That dramatic turnaround revealed a vital truth: in humans with osteoarthritis—whether driven by injury or obesity—adenosine levels fall even as receptor numbers rise in compensation. Restoring adenosine, then, isn’t merely symptomatic relief; it strikes at the disease’s root. It was in that moment that Regenosine was born, marking a breakthrough in the battle against a devastating disease. No costly surgery. No repeat replacements. Just a shot that targets osteoarthritis at its source. Embarking on the journey to develop an injectable outpatient therapy, Dr. Siddhesh Angle, the founder and CEO of Regenosine, put it best: “Don’t just watch the future unfold—make it happen.” While current treatments respond to damage already done, the company aims to rewrite the course of the disease, preserving joint function before it’s lost. Most importantly, it offers the life-changing potential to maintain an active lifestyle, prevent loss of mobility and diminish the need for surgery in the nearly 10% of the American population suffering from osteoarthritis. “We are stuck in a cycle of diminishing returns, and the real issue is that we haven’t had truly effective, disease-modifying therapies for osteoarthritis,” says Dr. Angle. “That’s the gap we are closing with our proprietary liposomal adenosine technology.”.
Drug Discovery and Development
In the world of rare diseases, few conditions are as physically and emotionally grueling as epidermolysis bullosa simplex (EBS). Often diagnosed in infancy, EBS causes fragile skin to blister and tear at the slightest touch, leading to chronic or recurring wounds, intense pain, and a lifetime of limitations. For the estimated 20,000 people in the U.S. living with EBS, there is still no FDA-approved, disease-modifying treatment. That stark reality is what drives BioMendics—a biotechnology company with a clear and urgent mission to develop therapies that go beyond symptom management and truly change the course of the disease. At the heart of its work is TolaSure®, a topical gel created using the company’s proprietary MTORX™ liquid crystal platform. “Unlike existing treatments, which focus on bandaging and soothing wounds, TolaSure® is designed to address the root cause of EBS— mutated keratin proteins that weaken the skin’s structural integrity,” says Karen McGuire, CEO and co-founder. TolaSure® embodies BioMendics’ commitment to tackling EBS at its source. Formulated on the company’s proprietary MTORX™ liquid crystal platform, this topical gel is designed to reduce both the frequency and severity of blistering by targeting mutant keratin aggregates that compromise the skin’s structure. Easy to apply and noninvasive, it brings hope—particularly to pediatric patients and their families—by offering a practical way to strengthen skin, especially in high-friction areas like the hands and feet. Yet scientific innovation is only half the story. From the very first human tests, BioMendics set out to create a trial experience founded on empathy and respect. In its Phase I study, every participant received comprehensive support—travel, lodging, and meals were fully covered, and clinic visits were scheduled to minimize disruption to daily life. One adult volunteer, who had endured severe EBS for years, reported that after using TolaSure®, they were finally able to wear dress boots without pain or blistering—an outcome that had once seemed unimaginable, and one that renewed hope not only for themselves but also for their child living with the same condition. These personal victories are far from exceptions; they are the lifeblood of BioMendics’ mission, as CEO Karen McGuire reflects on a guiding principle shared by many in the EB community: “Because the cost of doing nothing is too great.”.
Life Sciences Training
Educational Resource Systems, Inc. (ERS) is a premier life-sciences learning partner, designing custom training solutions – predicated on the science of how people learn – that drive behavior change, accelerate performance, and align with strategic goals of transforming learning from a transactional activity into a catalyst for measurable organizational impact..
Cell and Gene Therapy
Every day, scientists ponder a critical question: “Isn’t there a better way to dissociate tissue without harming cells?” The frustration is real—enzymes, commonly used to separate tissue, often alter the very cells researchers aim to study. These methods can damage surface markers and erase the natural diversity of the tissue, leading to results that don’t truly reflect biology. As single-cell research continues to grow, the need for a gentler, more reliable alternative has never been greater. Cellsonics has answered that call. With its enzyme-free acoustic technology, SimpleFlow, the company is preserving the true nature of cells for the insights that matter most. The sound-based device gently separates the tissue using a proprietary combination of sound and mechanical movement to produce healthy, high-quality cells, which can be used in research techniques like single-cell RNA sequencing and flow cytometry. “Recognizing the scientific community’s urgent need for an alternative to enzymatic dissociation, we designed SimpleFlow to recover cell populations that better reflect the native tissue,” says Brian Quast, VP of sales and marketing. “Our goal is to ensure scientists get the most accurate results and receive maximum value from every experiment.” Enzymes Vs Acoustic While engaging with scientists, Cellsonics identified that some essential cell types like fibroblasts in skin and tumor-infiltrating lymphocytes (TILs) across various tissues are still hard to collect using conventional methods. Also, enzymes can harm sensitive cell populations, especially neurons and astrocytes in dissociated murine brain tissue. Considering all these challenges, the company conducted a recent test to compare the popular enzyme-based method with its SimpleFlow system. The result was remarkable: SimpleFlow recovered higher yields of both neurons and astrocytes, which has been a great encouragement for the Cellsonics team. This is just one instance. To further demonstrate the value of its flagship solution, the company carried out another experiment. Here, researchers worked with a type of cell that is identified using a specific surface marker, which is very sensitive to enzymes. Initially, they used traditional enzymatic dissociation but the marker got damaged, making it hard to sort and study the right cells. Although the team spent a considerable amount of time trying different enzyme mixtures, the outcomes remained inconsistent. Once they tried SimpleFlow, the difference was clear. The acoustic, enzyme-free method preserved the delicate surface marker entirely, allowing for more accurate cell sorting and analysis..
Supplements
The Significant Increase in Demand for Clinical Research Associates (CRAs)
Helen Yeardley, Executive Vice President, ICON [NASDAQ: ICLR]
Cell and Gene Therapy
Rapid Release Quality Control Solution for Cellular Therapies using Celsis ATP Amplified Bioluminescence
Jon Kallay, Senior Technology and Market Development Manager, Charles River Laboratories
Drug Discovery and Development
From Selection to Training: The Pillars of Successful Quality Outsourcing in Pharma
Jennifer Perrin, Director, MMS Holdings Inc
Antibodies
Leading-Edge Labs: A Blueprint For Exceptional Patient Care
Ancel R. Nelson, Laboratory Director, York Hospital
CRO
Quality Improvement in Healthcare Strategic Imperatives for Healthcare Leaders
Dr. Adrian Nedelcut, M.D., C.P.H.Q., H.A.C.P., Director of Quality and Regulatory Programs, Southeast Health
Life Science Testing
Cell Therapies: Here comes the next wave!
Robert Richards, Corporate Director of the Center for Cell Therapy and Transplant, Penn Medicine, University of Pennsylvania Health System
CDMO
Agility as the Superpower for Clinical Operations
John Benedetto, VP and Global Head of Clinical Development Operations, BioNTech SE
Life Science Facility Service
Navigating the Future of Pharmacy
Amos Chery, Director of Pharmacy Operations and Regulatory Compliance, MedStar Health
Next Generation Sequencing
Driving Improved Outcomes with Automation
Alex J Rai, Professor of Pathology and Cell Biology, Director, Clinical Chemistry Service, Columbia University Medical Center
IN MY OPINION
Cell and Gene Therapy
Meeting The Challenges Of Modern Healthcare Compliance
Vanessa Casella, Program Manager, Compliance Risk & Data Service, UChicago Medicine
LAST WORD
Cell and Gene Therapy
A Call To Action For Rare Diseases
Jeff Sherman, Chief Medical Officer, Horizon
IN FOCUS
Rebuilding Life: The Next Frontier in Tissue Regeneration
Tissue regeneration is advancing through the integration of biology, engineering, and medicine, with a focus on innovative therapies that utilize cells, scaffolds, and bioactive molecules for enhanced healing.
Navigating the Therapeutic Divide in Stem Cell Medicine
Regenerative medicine utilizes both autologous and allogeneic stem cell therapies, differing in their sourcing and application, to address diverse clinical needs, striking a balance between safety, scalability, and accessibility.
EDITORIAL
The Next Chapter in Life Sciences
Supporting this wave of innovation are top full-service scientific communications and regulatory submissions companies, which have become indispensable partners for biotechs and pharmaceutical firms. On the communications side, they prepare clinical study reports, investigator brochures and patient-facing materials that translate complex science into actionable knowledge for regulators and clinicians. On the regulatory side, they assemble dossiers for the European Medicines Agency and the U.S. FDA, aligning trial protocols with orphan drug designations. Their expertise is especially critical in rare dermatologic disorder medication development, where small patient populations demand scientific rigor and regulatory agility.
Meanwhile, advances in tissue dissociation solutions are enabling researchers to unlock insights at the cellular level, expanding the toolkit for drug discovery. This market alone is projected to approach USD 746.76 billion by 2025, with a CAGR of 8.6 percent.
This edition of the Life Sciences Review offers insights into the latest innovations in life sciences and advanced therapies, and how companies are aligning with these trends.
The magazine features a thought-provoking article from Dr. Amos Chery, Director of Pharmacy Operations and Regulatory Compliance at MedStar Health, where he explains how technology, automation, AI and outsourcing are reshaping pharmacy operations while calling for adaptive regulatory frameworks. An article from Vanessa Casella, Program Manager of Compliance Risk and Data Service at UChicago Medicine, explores the evolving demands of healthcare compliance.
We also bring you the stories of top life sciences companies. A noteworthy story is that of Auragens, a well-established company that provides customized treatments that restore the body’s natural healing power safely, transparently and without compromise.
In this edition featuring the life sciences and advanced therapy company of the Year 2025, we hope you gain fresh insights to advance your work in research, development and patient care.


