AGTC Genomics

09/08/2025

𝐘𝐨𝐮𝐫 𝐆𝐞𝐧𝐞𝐭𝐢𝐜 𝐁𝐥𝐮𝐞𝐩𝐫𝐢𝐧𝐭 𝐂𝐨𝐮𝐥𝐝 𝐌𝐚𝐤𝐞 𝐂𝐚𝐧𝐜𝐞𝐫 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐒𝐚𝐟𝐞𝐫

Chemotherapy: one size does not fit all

Chemotherapy saves lives — but it can also cause severe side effects in certain patients. Often, the reason lies in our DNA: small inherited differences in genes that control how our bodies process drugs.

Pharmacogenetic testing can detect these differences before treatment begins, allowing oncologists to adjust the drug or dosage to reduce life-threatening toxicity and avoid ineffective therapy.

Three well-proven examples where genetics matter

1. 𝐅𝐥𝐮𝐨𝐫𝐨𝐩𝐲𝐫𝐢𝐦𝐢𝐝𝐢𝐧𝐞𝐬 (5-𝐅𝐔, 𝐜𝐚𝐩𝐞𝐜𝐢𝐭𝐚𝐛𝐢𝐧𝐞) — DPYD gene Variants in the DPYD gene can drastically reduce DPD enzyme activity, leading to severe or fatal toxicity. Around 4–5% of cancer patients in some European cohorts carry actionable variants. Testing is now recommended before prescribing these drugs.

2. 𝐈𝐫𝐢𝐧𝐨𝐭𝐞𝐜𝐚𝐧 — UGT1A1 gene The UGT1A1*28 variant increases the risk of severe neutropenia. Its frequency varies by ancestry, reaching over 40% in African ancestry populations. Knowing a patient’s status helps tailor dosing safely.

3. 𝐓𝐡𝐢𝐨𝐩𝐮𝐫𝐢𝐧𝐞𝐬 (𝐦𝐞𝐫𝐜𝐚𝐩𝐭𝐨𝐩𝐮𝐫𝐢𝐧𝐞, 𝐚𝐳𝐚𝐭𝐡𝐢𝐨𝐩𝐫𝐢𝐧𝐞) — TPMT & NUDT15 genes Low enzyme activity in TPMT or NUDT15 can cause dangerous bone marrow suppression. Roughly 10% of people carry one low-activity allele, and 1 in 300 have very low/absent activity — directly informing safer starting doses.

𝐈𝐬 𝐭𝐞𝐬𝐭𝐢𝐧𝐠 𝐜𝐨𝐬𝐭-𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞?
For DPYD testing, studies show modest added costs per patient but significant gains in quality-adjusted life years (QALYs). Broader pre-emptive pharmacogenomic panel testing has also been shown to be cost-effective in many healthcare models.

Why pre-emptive testing (the “genetic passport”) makes sense
Traditionally, testing happens reactively — only when a drug is prescribed or after a bad reaction. Pre-emptive testing stores your pharmacogenetic profile in your medical record, ready for any future prescription.

With falling costs of whole-genome sequencing (WGS), capturing all relevant pharmacogenetic variants in one go is now feasible. Several national pilots — even in newborns — are testing the concept.

𝐁𝐨𝐭𝐭𝐨𝐦 𝐥𝐢𝐧𝐞 𝐟𝐨𝐫 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬
Certain chemotherapy drugs have genetic tests that can prevent severe harm — ask about DPYD, UGT1A1, TPMT, and NUDT15 before treatment.

Evidence shows testing is clinically useful and often cost-effective.
Pre-emptive and whole-genome strategies could make safer, personalised prescribing routine in the near future.

Your DNA might not just guide your treatment — it could save your life.

09/08/2025

🚀 𝐀𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐓𝐡𝐫𝐨𝐮𝐠𝐡 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐏𝐚𝐭𝐡𝐨𝐥𝐨𝐠𝐲 & 𝐀𝐈

AGTC Genomics is proud to announce a landmark collaboration with CytoVision, KFBIO, Singapore General Hospital, and National University Hospital Singapore to jointly develop cutting-edge digital pathology and AI solutions for multiomics analysis.

This partnership brings together expertise in genomics, digital pathology, and artificial intelligence — integrating molecular insights with high-resolution histopathology to deliver faster, more accurate, and more comprehensive diagnoses.

By bridging the gap between pathology and multiomics data, we aim to:

- Enhance diagnostic precision and reduce turnaround times

- Enable earlier disease detection and tailored treatment planning

- Support clinicians with AI-assisted decision-making tools

- Improve patient outcomes across oncology, rare diseases, and other complex conditions

This collaboration represents a new benchmark in integrated precision medicine, where the convergence of advanced sequencing, digital pathology, and AI will make personalised, data-driven patient care more accessible than ever.

Together, we are redefining how medical data is connected, analysed, and translated into actionable insights for better patient care.

31/07/2025

🚨 𝘌𝘝𝘌𝘕𝘛 𝘈𝘕𝘕𝘖𝘜𝘕𝘊𝘌𝘔𝘌𝘕𝘛 | 1 𝘈𝘜𝘎𝘜𝘚𝘛 2025

🔬 𝘈𝘥𝘷𝘢𝘯𝘤𝘪𝘯𝘨 𝘎𝘦𝘯𝘰𝘮𝘪𝘤 𝘙𝘦𝘴𝘦𝘢𝘳𝘤𝘩 𝘸𝘪𝘵𝘩 𝘗𝘢𝘤𝘉𝘪𝘰: 𝘐𝘯𝘴𝘪𝘨𝘩𝘵𝘴 𝘪𝘯𝘵𝘰 𝘓𝘰𝘯𝘨-𝘙𝘦𝘢𝘥 𝘚𝘦𝘲𝘶𝘦𝘯𝘤𝘪𝘯𝘨 𝘢𝘯𝘥 𝘵𝘩𝘦 𝘝𝘦𝘨𝘢 𝘚𝘺𝘴𝘵𝘦𝘮

📍 𝘐𝘔𝘜 𝘜𝘯𝘪𝘷𝘦𝘳𝘴𝘪𝘵𝘺, 𝘉𝘶𝘬𝘪𝘵 𝘑𝘢𝘭𝘪𝘭 | 9:00 𝘈𝘔 – 12:30 𝘗𝘔

We are excited to invite you to a focused half-day seminar exploring the power of long-read sequencing and the PacBio Vega system. Whether you're a researcher, clinician, or technology enthusiast, this is a rare opportunity to:

✅ Deepen your understanding of PacBio's HiFi sequencing technology

✅ Discover the clinical applications of long-read sequencing in rare and genetic diseases

✅ Engage in live demo of the cutting-edge PacBio Vega system

✅ Connect with local and international experts in genomics

🎤 Featuring speakers from IMU, PacBio, Xcelom, DKSH, and AGTC Genomics.

🗓 Seats are limited! Registration closes 30 July 2025.

📞 To RSVP or for more info: marketing.tech@dksh.com | 03-7882 8711

Let’s shape the future of precision medicine and genomic discovery—together.

31/07/2025

A major clinical initiative is highlighting how pharmacogenomic testing can transform prescribing practices by matching medications to each individual’s genetic profile. By evaluating responses to over 60 widely prescribed drugs, this approach helps minimize side effects, avoid treatment failures, and support more precise, data-driven care.

This real-world trial reinforces the global momentum toward integrating pharmacogenomic testing into everyday medical practice. It echoes the principles of emerging precision platforms developed regionally, where tailored PGx testing is now being deployed to support local clinicians in optimizing therapy choices, particularly in cardiology, psychiatry, geriatrics, and general medicine. As healthcare systems increasingly adopt genetics-driven tools to refine dosing and drug selection, such platforms—especially those built through homegrown R&D—are well-positioned to lead the way in improving patient care while offering cost-effective, scalable solutions.

Necessary cookies enable core functionality. The website cannot function properly without these cookies, and can only be disabled by changing your browser preferences.

29/07/2025

🧬🩸 Can We Detect Cancer Years Before Symptoms? New Study Says Yes.

A breakthrough study published in Cancer Discovery (July 2025) demonstrates that circulating tumor DNA (ctDNA) can be detected in plasma samples collected more than 3 years before a clinical cancer diagnosis.

📌 Study Title: Detection of Cancers Three Years prior to Diagnosis Using Plasma Cell-Free DNA

🧪 Authors: Yuxuan Wang et al.
🔗 DOI: 10.1158/2159-8290.CD-25-0375

🔍 Key Findings:

✅ A multicancer early detection test (MCED) flagged 8 participants with cancer before diagnosis—all confirmed within 4 months

✅ In 6 of these 8, researchers analyzed older plasma samples collected ~3.2 years prior

✅ In 4 of the 6, the same mutations were found—at 8.6–79x lower mutant allele fractions

✅ Demonstrates feasibility of ultra-early detection using cell-free DNA (cfDNA)

💡 Why This Matters:

🔬 Earlier = Better. Detecting cancer before symptoms allows for:
Less invasive treatments
Better survival outcomes
Reduced healthcare costs

📊 This study sets new benchmark sensitivity requirements for detecting ctDNA at very low levels—a leap forward for the liquid biopsy field.

🧠 Implication for Innovation:
Future cancer screening may shift toward proactive blood-based surveillance, turning annual checkups into early detection powerhouses.

🧭 What’s Next?
Wider validation, cost-effective scaling, and integrating ctDNA surveillance into routine care could redefine early cancer management—and save countless lives.

23/07/2025

🧬 𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐒𝐭𝐚𝐫𝐭𝐬 𝐇𝐞𝐫𝐞: 𝐆𝐞𝐧𝐞𝐭𝐢𝐜 𝐇𝐞𝐚𝐥𝐭𝐡 𝐒𝐜𝐫𝐞𝐞𝐧𝐢𝐧𝐠 𝐛𝐲 𝐀𝐆𝐓𝐂 𝐆𝐞𝐧𝐨𝐦𝐢𝐜𝐬 𝐍𝐨𝐰 𝐀𝐯𝐚𝐢𝐥𝐚𝐛𝐥𝐞 𝐚𝐭 𝐋𝐞𝐚𝐝𝐢𝐧𝐠 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐏𝐫𝐨𝐯𝐢𝐝𝐞𝐫𝐬

We’re proud to announce that AGTC Genomics’ clinical-grade Precision Genetic Health Screening is now available through our partner healthcare institutions across Malaysia.

Designed for clinical relevance and actionability, our screening panels go beyond consumer-level DNA kits to offer Next-Generation Sequencing (NGS) and polygenic risk scoring (PRS) across key health domains:

🔹 Nutrigenomics - Discover how your genes influence nutrient absorption, metabolism, and dietary needs — for personalised nutrition that supports long-term health.

🔹 Pharmacogenomics - Understand how your genetic profile affects your response to medications, enabling safer, more effective prescriptions tailored to you.

🔹 Allergies - Identify genetic predispositions to allergic conditions like asthma, eczema, and food sensitivities for early intervention and better management.

🔹 Cancer Risk - Assess inherited genetic variants associated with increased risk for cancers such as breast, ovarian, colorectal, and prostate — even without symptoms.

🔹 Heart Disease Risk - Reveal your genetic susceptibility to cardiovascular conditions including hypertension, high cholesterol, and coronary artery disease for early prevention.

🔹 Diabetes Risk - Gain insight into your inherited risk for insulin resistance and Type 2 diabetes through advanced polygenic risk scoring.

🔹 Family Planning (Carrier Screening) - Screen for carrier status of inherited genetic disorders to support informed reproductive decisions and protect future generations.

With certified reports and the option for medical genetic counselling, this solution supports physicians, specialists, and wellness practitioners in delivering truly personalised, preventive care.

We invite clinicians and healthcare professionals to explore how genomic screening can be integrated into practice to identify at-risk individuals before symptoms appear — transforming care from reactive to proactive.

🔬 Powered by AGTC Genomics – advancing precision medicine for all.

22/07/2025

🚀 𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐞 𝐓𝐚𝐤𝐞𝐬 𝐂𝐞𝐧𝐭𝐞𝐫 𝐒𝐭𝐚𝐠𝐞 𝐚𝐭 𝐀𝐬𝐢𝐚’𝐬 𝐋𝐚𝐫𝐠𝐞𝐬𝐭 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐋𝐚𝐛 𝐄𝐱𝐩𝐨! 🔬

We are truly honoured to have been invited to share our insights at the recently concluded WHX Lab Kuala Lumpur and the 34th National Scientific Conference of MIMLS, held from July 14–16 at Mitec, Kuala Lumpur — a landmark event that welcomed over 10,000 attendees and set new benchmarks for Asia’s medical laboratory community.

💡 A big THANK YOU to the Organising Committee for curating such an impactful platform and for giving us the opportunity to highlight how Precision Medicine in Malaysia is no longer a dream, but a reality.

From cancer genomics to rare disease diagnostics, pharmacogenomics, and liquid biopsy innovations, we are proud to be part of the movement making advanced healthcare more accessible and affordable for Malaysians.

It was inspiring to see how local champions are leading the charge:

🏥 Premier Integrated Labs, Sunway Medical Centre, Innoquest Diagnostics and Lablink Medical Laboratory: Expanding the frontiers of hospital-based diagnostics

🔬 Malaysia Genome and Vaccine Institute, UKM Medical Molecular Biology Institute (UMBI), and other research giants: Powering national-scale genomics and translational research

This convergence of public-private-academic excellence proves that Malaysia is ready to lead the precision health revolution in Asia — with innovation, access, and patient empowerment at the core.

🎯 At AGTC Genomics, we are not just another lab. We are a next-generation genomics technology company, focused on building proprietary platforms, deep-tech innovation, and clinically validated tools that transform how healthcare is delivered.

From comprehensive cancer profiling to liquid biopsy, digital PCR, AI-enabled multi-omics, and personalised health solutions, we are setting the pace for precision medicine in Malaysia and beyond — not by adopting technology, but by building it.

The momentum is clear: Malaysia is ready to lead the precision health revolution in Southeast Asia, powered by its own innovators.

Let’s build the future — together!

Bioeconomy Corporation
MRANTI
Kementerian Sains, Teknologi dan Inovasi (MOSTI)

20/07/2025

🔬 𝐀𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐀𝐟𝐟𝐨𝐫𝐝𝐚𝐛𝐥𝐞 𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐞 𝐓𝐡𝐫𝐨𝐮𝐠𝐡 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩: 𝐀𝐆𝐓𝐂 𝐆𝐞𝐧𝐨𝐦𝐢𝐜𝐬 𝐱 𝐈𝐌𝐔 𝐔𝐧𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲

We are proud to announce our strategic partnership with Institute for Research, Development and Innovation IMU Universityt o accelerate the development and accessibility of affordable precision medicine solutions in Malaysia and beyond.

Through this MoU, AGTC Genomics and IMU University aim to:

🔬 Drive translational genomics and diagnostics research that addresses real-world healthcare challenges

🎓 Support industry-linked training and talent development to build future-ready precision medicine professionals

📚 Co-develop impactful publications and joint consultancy efforts, strengthening academic-industry integration

🤝 Facilitate staff attachments and knowledge exchange to scale expertise across both organisations

AGTC Genomics is committed to bringing world-class genomic technology and diagnostic innovation into academic and clinical settings—without compromising affordability or accessibility.

A sincere thank you to IMU’s Institute for Research, Development and Innovation IMU University team for your leadership and shared vision. This collaboration is a testament to what is possible when academia and industry unite with a common purpose: to transform lives through precision healthcare.

📢 Let’s make genomics work for everyone, not just a few.

20/07/2025

🌟 𝐂𝐨𝐧𝐠𝐫𝐚𝐭𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐭𝐨 𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐨𝐫 𝐃𝐫 𝐂𝐡𝐞𝐞-𝐎𝐧𝐧 𝐋𝐞𝐨𝐧𝐠, 𝐅𝐨𝐮𝐧𝐝𝐞𝐫 𝐚𝐧𝐝 𝐂𝐄𝐎 𝐨𝐟 𝐀𝐆𝐓𝐂 𝐆𝐞𝐧𝐨𝐦𝐢𝐜𝐬 𝐨𝐧 𝐁𝐞𝐢𝐧𝐠 𝐀𝐰𝐚𝐫𝐝𝐞𝐝 𝐭𝐡𝐞 𝐅𝐞𝐥𝐥𝐨𝐰 𝐨𝐟 𝐭𝐡𝐞 𝐀𝐜𝐚𝐝𝐞𝐦𝐲 𝐨𝐟 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 𝐌𝐚𝐥𝐚𝐲𝐬𝐢𝐚 (𝐅𝐀𝐒𝐜)! 🌟

AGTC Genomics is proud to celebrate a momentous milestone achieved by our Founder and CEO, Professor Dr Chee-Onn Leong, who has been awarded the prestigious Fellowship of the Academy of Sciences Malaysia (ASM) in the field of Medical and Health Sciences — the highest scientific recognition in the country.

Prof. Leong’s journey in science began with a Bachelor of Biomedical Science (Hons) from Universiti Putra Malaysia (UPM). He then pursued a PhD in Pharmacy at the University of Nottingham, UK, where his research directly contributed to the development of a novel anticancer drug candidate that advanced to Phase I clinical trials in the UK.

He was then awarded a Postdoctoral Fellowship at Harvard Medical School and Massachusetts General Hospital, where he helped define the five major subtypes of breast cancer, including the basal-like subtype — transforming breast cancer treatment strategies globally. His work has been published in leading journals such as Nature Cell Biology, Cancer Cell, PNAS, and Journal of Clinical Oncology.

Prof. Leong has since translated cutting-edge research into real-world solutions. Under his leadership, AGTC Genomics successfully developed and commercialised:

🧬 Malaysia’s first Multi-Cancer Early Detection (MCED) test

🧪 Customised oncology panels that predict therapeutic response

🔬 Region-specific biomarkers for cancers like nasopharyngeal carcinoma (NPC)

These innovations are now used in both public and private healthcare systems, enabling better patient outcomes, reducing ineffective treatments, and lowering healthcare costs.

He is also an influential academic leader, having served as Deputy Director of Research and Head of the Cancer & Stem Cell Research Group at the Institute for Research, Development and Innovation IMU University (IRDI), where he fostered a deep passion for translational research and commercialization. Today, Prof. Leong continues to shape future scientists as:

🎓 Adjunct Professor at IMU University, Sunway University, and Universiti Tunku Abdul Rahman (UTAR)

🎓 Visiting Professor at University of Malaya, NUS, UHK, and University of Glasgow

🎓 Industry Advisory Board Member at UCSI, University of Nottingham Malaysia, and others

As a former Chair of Science Policy in Young Scientists Network - Academy of Sciences Malaysia (YSN-ASM) and contributor to Science Outlook 2015, he has helped shape national research direction and innovation policy.

This Fellowship from ASM is a testament to Prof. Leong’s unwavering commitment to advancing science, improving lives, and building Malaysia’s position in precision medicine, genomics, and cancer research. Congratulations, Prof! Your journey continues to inspire.

Bioeconomy Corporation
MRANTI
Kementerian Sains, Teknologi dan Inovasi (MOSTI)
Akademi Sains Malaysia
KEMENTERIAN KESIHATAN MALAYSIA

18/07/2025

From Lab Bench to Bedside: NGS in Regulatory-Grade Stem Cell QC

As stem cell-based therapies advance from research labs to clinical settings, regulatory expectations are evolving—and rising. No longer is visual inspection or surface marker profiling enough. Regulators now demand comprehensive, molecular-level characterization to ensure safety, consistency, and efficacy in every batch of cells delivered to patients.

This is where Next-Generation Sequencing (NGS) becomes not just a research tool, but a clinical necessity.

From preclinical validation to GMP-grade manufacturing, NGS is helping companies meet—and exceed—the stringent requirements set by regulatory bodies like the FDA, EMA, and PMDA for cell and gene therapy products.

🧬 What Do Regulators Expect?
Agencies now require evidence of:

Genomic stability: No tumorigenic mutations, no unexpected chromosomal changes

Identity verification: Molecular confirmation of pluripotency or lineage commitment

Purity and safety: Absence of undifferentiated cells, off-target populations, and contamination

Traceability: Ability to track every step of the process, from donor to dose

NGS enables all of the above through high-resolution, high-throughput molecular profiling.

🔬 NGS Applications in GMP-Compliant Stem Cell QC
WES/WGS for Genomic Integrity

Detects SNVs, CNVs, and structural variants

Verifies absence of oncogenic mutations (e.g., TP53, BRCA2, MYC amplifications)

RNA-seq and scRNA-seq for Identity & Differentiation Status

Confirms expected gene expression profiles

Flags undifferentiated or off-target subpopulations

Epigenomic Assays (WGBS, ATAC-seq, ChIP-seq)

Ensures functional integrity and developmental potential

Supports comparability across batches and sites

NGS for Contamination Control

Broad-spectrum detection of bacteria, fungi, mycoplasma, and viruses

Complements sterility and endotoxin testing in GMP workflows

📦 From Product Release to Post-Market Surveillance
NGS plays a pivotal role in batch release criteria, helping define:

Release specifications for potency, purity, and identity

Acceptance thresholds for genomic stability

Documentation for regulatory filings and audits

In the near future, we’ll see multi-omics-based release assays—combining genomics, transcriptomics, epigenomics, and proteomics—used to develop predictive potency models, enabling faster, safer release of stem cell products into clinical use.

🌟 Final Thought
Translating stem cell science into clinical reality requires more than innovation—it demands rigorous validation. NGS delivers the data-driven insights needed to build regulatory confidence, accelerate approvals, and ensure patient safety.

👉 Clinical-grade stem cell products demand clinical-grade NGS solutions.

17/07/2025

Clean Cells, Clear Results: NGS for Contamination Control

🧫 Microbiome and Contaminant Screening in Stem Cell Cultures

Stem cell research demands precision—and nothing disrupts precision like hidden contamination.

Despite rigorous aseptic techniques and routine monitoring, microbial contamination remains a persistent threat in cell culture environments. From bacteria and fungi to viruses and mycoplasma, even trace contaminants can skew experimental results, alter cell behavior, or render entire batches of therapeutic cells unsuitable for clinical use.

That’s why Next-Generation Sequencing (NGS) is increasingly being adopted as a sensitive, comprehensive, and unbiased approach to contamination detection in both research and GMP settings.

🔬 Limitations of Traditional Methods
Conventional methods such as:

Microscopy only detect visible contaminants.

Culture-based assays take time and may miss fastidious organisms.

PCR kits require prior knowledge of what to test for.

These approaches can lead to false negatives, allowing low-level contamination to persist undetected. This is especially dangerous in stem cell applications, where cells are expanded over long periods and used in highly sensitive clinical contexts.

🧬 How NGS Improves Contamination Control
NGS enables:

Broad-Spectrum Detection

16S rRNA sequencing identifies bacterial contaminants at genus or species level—even unculturable microbes.

Metagenomic sequencing detects a full range of microbial DNA/RNA, including fungi, viruses, and bacteriophages, in a single test.

Targeted Mycoplasma Screening

Mycoplasma, a common and insidious contaminant, is often missed by basic tests.

Targeted NGS panels can detect multiple Mycoplasma species with high sensitivity and specificity—even when levels are below detection thresholds of PCR.

Source Tracing and Root Cause Analysis

By sequencing the full contaminant genome, labs can trace the source of contamination (e.g., media, reagents, personnel) and implement corrective actions.

Batch-Level Sterility Assurance in GMP Settings

For stem cell products manufactured under Good Manufacturing Practice (GMP), NGS complements traditional sterility testing and provides a higher standard of microbial safety.

🧪 Case Study Applications
Before cryopreservation: Ensure long-term storage of clean stem cell lines.

During expansion phases: Monitor for low-level contamination that might amplify.

Pre-release of therapeutic batches: Provide additional assurance to regulators and clinicians.

NGS-based sterility checks are already being implemented in advanced cell therapy facilities, especially in CAR-T, iPSC-derived therapies, and ex vivo gene editing workflows.

🌟 Final Thought
In stem cell production, contamination is not just a setback—it’s a safety risk. NGS turns routine QC into comprehensive microbial surveillance, helping you catch what others can’t.

👉 Quality assurance isn’t complete without NGS-based sterility checks.

16/07/2025

From Stem to Specialized: Tracking Differentiation with scRNA-Seq

🔬 Stem Cell Differentiation Monitoring with Single-Cell RNA Sequencing

In stem cell research, differentiation isn’t just about what cells are supposed to become—it’s also about what they might accidentally become.

Whether we’re guiding pluripotent stem cells into neurons, cardiomyocytes, or pancreatic islets, the process is inherently complex and dynamic. Even under tightly controlled protocols, not all cells follow the intended lineage path. Some may diverge, stall, or differentiate prematurely—bringing risks of poor functionality, contamination, or variability in therapeutic outcomes.

That’s why researchers are increasingly turning to single-cell RNA sequencing (scRNA-seq) to monitor, validate, and optimize stem cell differentiation with unparalleled precision.

🧬 Why Single-Cell Matters
Unlike bulk RNA-seq, which provides an average gene expression profile across a population of cells, scRNA-seq resolves gene expression at the individual cell level. This enables researchers to:

Track lineage commitment in real time

Map developmental trajectories from pluripotency to specialized states

Quantify heterogeneity and detect undesired or off-target cell types

Identify rare subpopulations that could impact function or safety

In regenerative medicine, consistency is key—and scRNA-seq gives us the resolution to ensure that every cell is on the right path.

🧪 scRNA-seq Applications in Differentiation
Lineage Validation

Confirm that cells express the right markers at each stage of differentiation.

Detect misdirected or dedifferentiated cells that may compromise therapy.

Protocol Optimization

Compare how different growth factors, matrix conditions, or passage numbers influence the cellular trajectory.

Fine-tune induction steps based on real-time transcriptional feedback.

Purity Assessment Before Clinical Use

Quantify the percentage of differentiated versus undifferentiated or off-target cells in your final product.

Reduce the risk of introducing tumorigenic or immunogenic cells into patients.

Developmental Modeling & Drug Screening

Model diseases in vitro with patient-derived iPSCs and monitor cellular response to treatment at single-cell resolution.

⚠️ The Cost of Ignoring Heterogeneity
Incomplete differentiation can result in mixed populations that behave unpredictably in vivo.

Undifferentiated cells, especially in iPSC-derived products, carry a risk of teratoma formation.

Minor populations of unintended lineages may skew functional outcomes in disease modeling or tissue regeneration.

scRNA-seq acts as an early warning system, flagging discrepancies before they translate into real-world consequences.

🌍 From Research to GMP
While scRNA-seq is traditionally used in discovery research, its integration into manufacturing pipelines is growing. Companies developing GMP-compliant stem cell therapies are adopting scRNA-seq to:

Validate process consistency across batches

Support regulatory submissions with high-resolution cellular profiling

Develop reference atlases for quality assurance

🌟 Final Thought
Differentiation is the most critical—and most error-prone—step in stem cell therapy. With scRNA-seq, we finally have the resolution to guide, monitor, and validate this journey with scientific confidence.

👉 Precision differentiation begins with precise sequencing.