When it comes to clinical-grade CRISPR, the importance of rigorous cGMP (current Good Manufacturing Practice) compliance cannot be overstated. Substandard or misrepresented GMP products can derail therapeutic programs, leading to costly setbacks and regulatory challenges. At Synthego, we deliver on what others merely promise - true GMP CRISPR products that meet the strictest FDA and ICH regulatory standards and accelerate your clinical success.
Choosing the right GMP supplier requires more than a surface-level review. Not all products labeled “GMP” are created equal. In fact, regulators will hold your organization ultimately accountable for the quality of materials used in your clinical program. It is critical to follow a thorough, step-by-step evaluation process to qualify a GMP supplier. Below is a list of key criteria and red flags to guide your evaluation.
Verify that the supplier operates in appropriately certified facilities - ideally ones that are ISO-certified and, if applicable, FDA-inspected manufacturing facilities adhering to GMP and quality systems regulations, such as FDA 21 CFR Parts 210 and 211 for pharmaceutical GMP and ICH Q7 guidelines for active pharmaceutical ingredients. European compliance is equally important; ensure alignment with EMA’s GMP guidelines for APIs (e.g., EudraLex Volume 4, Part II, which mirrors ICH Q7).
Beware of suppliers who only offer vague statements like “GMP-like” or "GMP Compliant" without providing specific documentation or regulatory alignment.
Facilities that do not adhere to FDA-defined GMP requirements (21 CFR Parts 210 and 211;ICH Q7) risk contamination, batch inconsistencies and regulatory non-compliance. A compliant facility must have validated cleanrooms, controlled air handling, documented environmental monitoring (particulate/microbial), and qualified equipment (IQ/IQ/PQ for synthesizer, HPLC, filtration). Missing these controls threatens product integrity and clinical timeline.
Our state-of-the-art GMP facility is ISO 9001:2015 certified and meets FDA guidelines under 21 CFR Parts 11, 210 and 211, ensuring full compliance with pharmaceutical and biologics production standards for both process integrity and product safety. We maintain controlled cleanroom environments with validated equipment, and our processes have successfully passed multiple customer audits. When you work with Synthego, you partner with a supplier that has been proven at the highest level of compliance.
Verify that the supplier follows a validated QMS with stringent controls at every stage of production. A true GMP manufacturer will have an established QMS that covers deviation management, proper environmental monitoring, equipment validation, change control systems, and more. For example, formal change control procedures should be in place to evaluate and approve any changes to materials, processes, or analytical methods before implementation. The QMS should align with industry guidelines like ICH Q10 and ensure compliance at every stage of production.
The absence of a transparent QMS or hesitation to share details about their quality procedures is a red flag. If the supplier lacks a documented change control process or cannot describe how they validate equipment and methods, it is a signal of insufficient compliance controls.
Synthego’s QMS is modeled on pharmaceutical guidelines (ICH Q10 and others) and fully aligns with FDA and ICH expectations. We enforce stringent controls at every stage of production - from raw material qualification and equipment calibration to in-process monitoring and comprehensive batch release testing. Our QMS includes robust change control, deviation management, and continuous improvement practices, all overseen by an experienced Quality Assurance team. We adhere to data integrity principles with electronic batch records in manufacturing execution systems to ensure compliance with FDA 21 CFR Part 11 (electronic records and signatures) and GMP requirements.
Regulatory bodies have stringent standards for purity, activity, and specificity of gene editing components, all of which are critical for therapeutic success. Your GMP CRISPR supplier should employ validated analytical methods aligned with FDA and ICH standards to detect and quantify impurities such as residual solvents, partial sequence contaminants, and endotoxins, which could compromise safety or efficacy.
Advanced characterization techniques such as high-resolution mass spectrometry and sequencing-based methods should be used to verify molecular identity, purity, and batch-to-batch consistency. Equally critical are stability studies assessing the long-term quality and efficacy of CRISPR components. Collectively, these elements safeguard patient safety, reduce risks, and ensure reliability at scale, aligning with the FDA’s exacting standards.
Outdated analytical methods that lack the sensitivity or resolution needed for modern GMP standards compromise data reliability and accuracy. The absence of proper validation data for analytical techniques creates gaps in quality control, increasing the likelihood of errors and inconsistencies. Suppliers who provide incomplete reports, such as missing purity profiles or activity assays, demonstrate a lack of transparency and oversight. Generic testing standards that fail to align with specific therapeutic requirements further indicate an inability to handle complex or innovative projects. These issues collectively jeopardize product quality and regulatory compliance.
We implement extensive quality control testing on our clinical gRNA products including purity, impurity, sequencing information, and residual contaminants (residual solvents and elemental impurities), and ICH compliant stability studies to establish robust expiry dating for the gRNA product. All analytical methods used for release and characterization are fully validated according to ICH Q2 standards, ensuring accuracy and reproducibility of results. This rigorous analytical and quality assurance framework guarantees that Synthego’s GMP gRNAs consistently meet the specifications and regulatory expectations-de-risking your therapeutic program.
A reliable GMP supplier will provide comprehensive documentation for each batch - batch records, certificates of analysis (CoA), and certificates of compliance. Look for traceability across raw materials, processes, and testing. Robust document control ensures that you can trace the history of the gRNA molecule from starting material through final release.
If a supplier cannot produce CoA, batch records, or other evidence of compliance, this indicates a lack of traceability and control. Missing or minimal documentation is a major warning sign that the supplier’s processes may not withstand FDA/EMA scrutiny.
All Synthego GMP products are backed by meticulous documentation packages designed to ensure full transparency and traceability at every step of the manufacturing process. Each GMP batch is accompanied by a complete set of records, including the Certificate of Analysis (CoA), executed batch records, certificate of conformance, validation reports, and disposition forms. These documents serve as critical tools for verifying compliance with GMP regulations, offering clear evidence of product quality, consistency, and safety.
A top tier supplier should offer more than just manufacturing - they should serve as a partner in regulatory compliance. Look for suppliers that provide guidance on meeting regulatory requirements, support in preparing CMC documentation for IND/CTA filings and even referenceable Drug Master Files. A true GMP partner will have a Drug Master File (DMF), and will assist with letters of authorization or other documentation to support your filings. They should stay up-to-date with the latest guidelines (FDA, EMA, ICH) and proactively share any changes or requirements that could affect your product.
If a supplier is unwilling or unable to support your regulatory needs - for example, if they cannot provide a DMF or are unfamiliar with clinical trial submission requirements - consider it as a serious red flag. Miscommunication or ignorance in this area can lead to compliance gaps. You want a supplier who is as invested in the successful approval of your therapy as you are, not one who leaves you to figure out regulatory compliance on your own.
We uphold global compliance standards, including FDA and ICH guidelines, to support regulatory submissions at every phase of development. Our team provides detailed strategies grounded in these regulations, ensuring a streamlined path from pre-clinical optimization to clinical trials. We maintain an active Drug Master File (DMF) with the FDA. This means you can reference our DMF in your IND or TA, simplifying your filings and giving regulators confidence in the quality of your gRNA source. Synthego’s team is also available to assist with answering regulator inquiries about gRNAs, so you won’t be alone in navigating compliance requirements.
True GMP products must offer consistent, scalable production while maintaining uniform quality and adherence to rigorous clinical requirements.
Suppliers with little or no history of producing GMP materials at the required scale pose a risk. Inexperience can lead to inconsistencies or process failures, leading to disruptions at critical phases.
With more than 200 GMP batches produced, 12 successful IND submissions, and over 40 company audits completed with distinction, Synthego brings a proven track record to every project. Since pioneering GMP CRISPR manufacturing in 2020, Synthego has solidified its position as a trusted leader and was among the first to supply GMP-grade CRISPR materials. This depth of experience ensures consistent, scalable production processes that adhere to the highest standards of quality and regulatory compliance. By combining state-of-the-art technology with rigorous quality systems, Synthego empowers its partners to de-risk their development pipelines and achieve their clinical milestones with confidence.
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