UniPharma MB Labory｜cell therapy｜endotoxin mycoplasma

In recent years, Taiwan’s biotechnology and medical sectors have experienced significant growth, closely aligned with global scientific advancements. Research and development efforts continue to expand in advanced therapeutic modalities, including cell and gene therapies and nucleic acid–based medicines, collectively referred to as Advanced Therapy Medicinal Products (ATMPs).

As these innovative therapies play a critical role in the treatment of rare diseases, cancer, and other serious conditions, product quality and patient safety have become central pillars of regulatory review. Across all stages—research and development, clinical trials, and final product release—endotoxin and mycoplasma testing are recognized as indispensable quality control requirements for cell therapy products.

In accordance with international regulatory frameworks such as USP, EP, JP, ICH guidelines, and the PIC/S GMP quality system, manufacturers of cell-based and biological products must demonstrate that raw materials, reagents, and finished products meet stringent microbiological safety standards to ensure clinical safety, consistency, and reliability.

Endotoxin

Endotoxins are lipopolysaccharides (LPS) derived from the outer membrane of Gram-negative bacteria. Even when viable bacteria have been eliminated, endotoxins may persist in manufacturing environments, raw materials, or water systems. In humans, extremely low levels of endotoxin exposure can induce fever, hypotension, and systemic inflammatory responses, posing a significant risk—particularly for patients receiving cell therapy products.

As a result, endotoxin testing is universally mandated by regulatory authorities as a critical release criterion for cell-based medicinal products.

Mycoplasma

Mycoplasma are among the smallest self-replicating microorganisms and lack a cell wall, enabling them to pass through standard filtration systems and evade detection by conventional culture methods. More importantly, mycoplasma contamination can adversely affect cell growth, metabolism, gene expression, and immune responses, potentially leading to compromised research data and reduced clinical efficacy or safety.

Consequently, USP <63>, EP 2.6.7, and multiple cell therapy–related regulatory guidelines designate mycoplasma testing as a mandatory requirement prior to product release.

UniPharma MＢ Lab.: Committed to International Standards and Rigorous Quality Management

In the field of cell therapy testing, method sensitivity and suitability for complex biological samples are fundamental service requirements. Even when internationally accepted methods are employed, insufficient quality management systems or the absence of third-party accreditation may raise concerns regarding data credibility and regulatory acceptance.

UniPharma MB Lab. conducts endotoxin and mycoplasma testing in accordance with the Taiwan Pharmacopoeia (9th Edition) guidelines. Testing is performed on both raw materials and finished products. All laboratory procedures, data interpretation, and reporting strictly follow ISO/IEC 17025–based Standard Operating Procedures (SOPs), ensuring compliance with regulatory limits and safeguarding patient safety.

Endotoxin and Mycoplasma Testing Methods at Our MB Lab.

Category	Endotoxin	Mycoplasma
Applicable Products	Cell-based products (including cell-derived biologics, cell culture supernatants, and injectable products)
Regulatory References	Taiwan Pharmacopoeia (9th Ed.) Sections 3085, 3086	Taiwan Pharmacopoeia (9th Ed.) Sections 5063, 5064, 5326
Method Description & Advantages	Kinetic Turbidimetric Limulus Amebocyte Lysate (LAL) Assay The laboratory employs pharmacopoeial kinetic turbidimetric methods (KT), performed by trained professionals with precise sample pretreatment and continuous kinetic monitoring using an ELISA reader. Compared with traditional gel-clot methods, the KT method offers a wider quantitative range and stronger interference resistance, allowing more accurate endotoxin quantification in cell therapy products.	Real-time PCR Mycoplasma Detection High-performance nucleic acid amplification technology is applied to overcome the time-consuming nature and contamination risks of traditional methods, enabling rapid release assessment. PCR-based detection significantly shortens testing time, making it particularly suitable for cell therapy products with limited shelf life and supporting efficient manufacturing decisions.
Minimum Sample Volume	≥ 0.5 mL	≥ 1 mL
Sensitivity	0.01 EU/mL	10 CFU/mL
Turnaround Time	Standard: 7 business days Expedited: 3 business days	Standard: 7 business days Expedited: 3 business days
Deliverables	Endotoxin Test Report	Mycoplasma Test Report

A Regulatory-Driven Approach: Advancing Toward TAF Accreditation for Long-Term Trust

TAF (Taiwan Accreditation Foundation) accreditation is a key benchmark of laboratory quality systems in Taiwan and is fully aligned with ISO/IEC 17025 requirements for technical competence and quality management.

Achieving TAF accreditation signifies that a laboratory has successfully passed rigorous third-party assessments in the following areas:

Method validation and verification
Continuous personnel training and competency assessment
Regular calibration and maintenance of analytical instruments
Robust quality management systems and document control
Data reproducibility and traceability

UniPharma Molecular Laboratory is scheduled to obtain TAF accreditation in the first quarter of 2026, representing a major milestone in our commitment to regulatory compliance and analytical excellence.

Through this accreditation, we will continue to support cell therapy developers and medical institutions with high-quality, efficient, and reliable testing services, reinforcing regulatory confidence and contributing to a robust, internationally aligned quality foundation for Taiwan’s cell therapy industry.