Biotech - Articles
AI in clinical trials is addressing the challenges of escalating data complexity and accelerated timelines. AI in clinical trials is being used to handle increasing complexity, larger volumes of data, and shorter development timelines. It enhances not only operational efficiency but also the underlying approach to study design and management, facilitating faster and more reliable insights for strategic decisions. Introduction: Clinical Research at an Inflection Point Clinical trials remain the definitive mechanism for validating the safety, efficacy, and real-world applicability of new therapies and medical devices. Yet despite decades of methodological r…
The landscape of modern healthcare is undergoing a seismic shift, moving away from "one-size-fits-all" treatments toward a highly tailored, data-driven approach. At the heart of this transformation is the global biomarkers market. Valued at USD 85.9 billion in 2025, the sector is projected to surge to an astonishing USD 244.8 billion by 2034. This trajectory, representing a compound annual growth rate (CAGR) of 12.3%, underscores a fundamental change in how we diagnose, monitor, and treat chronic diseases. The Catalysts of Growth: Why Now? The explosive expansion of the biomarker…
Choosing the right EDC (electronic data capture) platform is critical for sponsors, CROs, and clinical operations teams running modern trials. In 2026, clinical trial software solutions have become increasingly sophisticated, ranging from enterprise suites to lean, budget-friendly tools. These clinical trial data capture software systems replace legacy tools with secure, centralized, and modern systems, ensuring 21 CFR Part 11 audit trails, encryption, and compliance with ICH-GCP guidelines. EDC systems are central to modern clinical trials, enhancing data accuracy while enabling real-time monitoring, faster database locks, and streamlined wor…
The desire to stay young is almost instinctive. Yet in recent years, that desire has evolved beyond simple beauty or wellness, transforming into an entire industry known as longevity. In the past, youthful appearance was often associated wit…
A clinical trial protocol is the foundation of clinical research, detailing objectives, study design, eligibility, safety oversight, and data analysis. Its structure ensures consistency and credibility, guiding investigators while protecting participants and maintaining scientific rigor. With digital solutions, eProtocols and AI are modernizing protocols in clinical trials, making processes more adaptive and reducing inefficiencies. Introduction Every clinical trial depends on a detailed plan that outlines how the study will be run, how participants will be safeguarded, and how results will be measured. This plan, called a clini…
Protein fermentation describes the microbial population's controlled breakdown and build-up of nitrogenous compounds under specific redox potential, pH balance and substrate limitation constraints. The process generally begins with the extracellular degradation of high molecular weight proteins. Protein hydrolysis by microbial aspartic proteases (fungi) or metalloproteases (bacteria) yields oligopeptides (2–20 residues) that are taken up into the cell via specific oligopeptide permeases. Intracellular di- and tri-peptidases further hydrolyze peptide…
Chemical Structure and Molecular Weight Polyethylene Glycol is the polymer form of EG, with its molecular weight varying depending on the degree of polymerization. The molecular weight of PEG generally ranges from hundreds to tens of thousands, while EG has a molecular weight of only 62. This difference in molecular weight leads to significant differences in their physical properties and applications. The polymer structure of PEG gives it higher viscosity and better biocompatibility, whereas EG's low molecular weight r…
Artificial intelligence (AI) is rapidly transforming biomarker discovery by unlocking insights from vast and complex datasets. Hurdle recently reviewed how revolutionary this technology could be, while also highlighting the potential hurdles that still stand in the way of its translation into the clinic. The Explosion of Data: Bigger, Broader, More ComplexLarge cohort studies are no longer a curiosity; they’re foundational. Crucially, these cohorts increasingly link rich electronic h…
In longitudinal clinical trials, missing data is a threat to scientific integrity. Whether due to patient dropouts, missed visits, or protocol deviations, these gaps can distort results, reduce statistical power, and invite regulatory scrutiny. With dropout rates averaging around 3-8% for the last three years, the stakes are high. As the industry continues to evolve, so should the str…
The Penicillin Active Pharmaceutical Ingredients (APIs) market represents a cornerstone of the global pharmaceutical industry, providing the essential building blocks for antibiotics that combat a wide range of bacterial infections. With its critical role in health…
In recent years, the healthcare industry has undergone rapid digital transformation. Among its key components is the adoption of Ambulatory EHR (Electronic Health Records in outpatient / ambulatory care settings) systems. These solutions are essential tools for physician offices, specialty clinics, and other outpatient facilities to maintain accurate patient histories, manage clinical workflows, enable remote care protocols, and meet regulatory requirements. As pressu…
What is Multiple System Atrophy and the Role of Therapeutics Multiple System Atrophy (MSA) is a progressive, rare neurodegenerative disorder adversely affecting the autonomic nervous system, movement, balance, coordination, and various bodily functions. Patients experience tremor, parkinsonian symptoms, cerebellar dysfunction, autonomic dysregulation (blood pressure, bladder control), and rapidly declining ability to perfor…
What Counts as a Human Biological Specimen? Human biol…
Nutrigenomics, the study of how our genes interact with diet, is emerging as one of the most promising areas in personalized health. Genetic variations can influence how we metabolize nutrients, respond to supplements, and manage risks for chronic conditions. Understanding these patterns opens new opportunities for preventative care, optimized wellness strategies, and more targeted i…
A successful design and development process must balance exploration with structure, enabling teams to build high-quality products efficiently while adapting to change along the way. Yet, while the traditional design process may comprise four to five defined phases, Hurdle believes there is more to consider from the outset. Elements such as business analysis, capability planning, budgetary controls, capabil…
The United States Food and Drug Administration’s (FDA’s) Accelerated Approval (AA) pathway, initially established in 1992 during…
Isomerase is a leading bioprocessing company that offers partners the ability to scale up their processes or projects from the lab to industrial manufacturing. Partners from various industries, including pharma, biotech, as well as food and ingredients, opt to work with our bioprocessing services when scaling. In this article, we provide an overview of what we offer, enabling you to make an informed decision when considering outsourcing. What is microbial bioprocessing? Once a microbe and the product of interest have been optimised, by engineering the production strain and/or target sequence, the process needs to be scaled. Generating such a product within a livin…
In recent years, the global health and wellness industry has seen an unprecedented evolution—not only in mainstream personal care but also in intimate hygiene. Among the most dynamic and increasingly visible segments is the intimate wash care products category, which has transitioned from niche awareness to everyday consumer routines in many parts of the world. As per data released by Acumen Research and Consulting, the global intimate wash care product market was valued at USD 28.6 billion in 2023 and is projected to reach USD 45.9 billion by 2032, expanding…
Biomaterials engineered to restore, replace, or augment damaged tissues are gaining momentum—and at the core are Regenerative Medicine Scaffolds, critical in advancing tissue repair across orthopedics, neurology, wound healing, and cardiovascular applications. Our recent analysis at Acumen Research & Consulting sheds light on shifting market dynamics, emerging technologies, and region-wise growth projections. Market Size & Growth Outlook The Regenerative Medicine Scaffolds Market Size reached USD 336.5 million in 2023 and is forecast to so…
Microbial Fermentation Services: From Strain Design to Scalable Process Fermentation is one of the oldest biotechnologies, yet it’s now driving some of the most cutting-edge innovations in health, nutrition, and sustainability. From therapeutic enzymes and precision fermentation ingredients to biodegradable materials and alternative proteins, microbial fermentation has re-emerged as a core engine of the modern bioeconomy. However, while the science behind engineered microbes is advancing rapidly, the path from disc…