Frequently Asked Questions about CellTrypase

You can order CellTrypase products directly from the CellTrypase website: Order now!

Looking for pricing details? CellTrypase is available in both R&D-grade and GMP-grade formats, with different sizes and concentrations to fit your workflow. Please finde a quick overview of available SKUs and pricing here.

We offer 100  mL samples for process development, testing, and qualification. Please reach out to your c-LEcta contact or request your free sample directly here.

For any questions or support, you can contact the CellTrypase expert team:

Vaishnavi Devarakonda: Contact Vaishnavi
Melissa Rangel: Contact Melissa
Sedef Özyürek-Heistermann: Contact Sedef

The estimated delivery time is 1-2 weeks, depending on your region.

CellTrypase is suitable for a wide range of applications in biopharma manufacturing and research, including:

- Passaging and expansion of adherent cell lines (e.g. Vero, MDCK, HEK293,…)
- Cell dissociation in vaccine and viral vector production for cell and gene therapies
- Processing of stem cells (e.g. iPSCs, hESCs and organoids)
- Isolation of primary cells (e.g. fibroblasts, keratinocytes, chondrocytes, neuronal cells)
- Cell banking and tissue engineering workflows
- General life science R&D use

CellTrypase is available in GMP-grade for clinical and commercial manufacturing, and in R&D-grade for early-stage development or research applications both with identical specifications, offering consistent performance and high purity.

Yes. CellTrypase is available in a GMP-grade specifically developed for use in clinical and commercial biomanufacturing processes.

CellTrypase GMP-grade is manufactured and distributed under a certified Quality Management System in compliance with Good Manufacturing and Distribution Practice (GMP/GDP) according to the EXCiPACT^® Certification Standard for pharmaceutical excipients. A Drug Master File (DMF) submission is part of our regulatory roadmap to support future global filings.

Yes. CellTrypase is intended as a direct alternative to TrypLE™ and other trypsin-based cell dissociation reagents. It offers equivalent performance, is compatible with existing protocols, and is available in GMP- and R&D-grades that match TrypLE™ Select as well as CTS and TrypLE™ Express, respectively.¹
Produced entirely in-house by c-LEcta, CellTrypase ensures high purity and secure supply.

¹ TrypLE™ is a registered trademark owned by Thermo Fisher Scientific Inc

Yes, CellTrypase is an ideal alternative to porcine trypsin. Produced under controlled, consistent conditions and formulated as a highly purified fungal enzyme, CellTrypase is inherently less reactive and so more gentle on cells. It offers:

- Comparable enzymatic activity
- Superior purity (≥95% by HPLC)
- More gentle cell dissociation with lower toxicity
- No need for inactivation
- Compatibility with existing protocols 

Yes. CellTrypase is entirely free from animal-derived components. The recombinant enzyme is manufactured by microbial fermentation and produced on animal origin-free equipment.

All raw materials, equipment, and packaging are certified as animal origin- and TSE/BSE-free. This ensures full compliance with regulatory expectations and minimizes the risk of contamination.

A proprietary GMP-compliant manufacturing process that meets the needs of customers looking for the highest quality and supply chain standards for their raw materials.

In-house production at our GMP-certified facility in Germany ensures full traceability and adherence to GMP/GDP requirements and offers a high security of supply. Gentle manufacturing steps preserve product integrity throughout the entire production process. The result is a high-quality enzyme solution. A purity of ≥95% is specified as a release-relevant parameter, ensuring consistent performance in sensitive cell culture applications

CellTrypase is also animal origin-free from start to finish: Produced on equipment in facilities where the use of animal-derived materials is strictly prohibited.

CellTrypase is filled into PET containers with HDPE lids and secured with a tamper-evident shrink seal. The primary packaging material complies with USP Class VI and 21 CFR standards for pharmaceutical use.

The product’s high stability allows shipment at ambient temperature.

EXCiPACT^® GMP is an internationally recognized quality certification for pharmaceutical excipients , but its principles are equally relevant for processing aids used in pharmaceutical manufacturing. The quality management system ensures that products, such as CellTrypase, are produced, stored, and distributed under controlled, traceable, and auditable conditions which meet the regulatory requirements of the pharmaceutical industry.

To achieve EXCiPACT^® GMP certification, a company must first implement and operate a certified ISO 9001 quality management system. EXCiPACT^® then adds specific GMP and GDP requirements tailored for materials going into pharmaceutical processes. These include documentation, hygiene, equipment, training, storage, and shipping.

- Ensures pharma-grade quality
- Accepted by global regulatory authorities (EMA, FDA, ANSM)
- Includes GDP-compliant storage and shipping
- Ideal for processing aids like CellTrypase used in vaccine, CGT, and biologics manufacturing

Learn more at https://www.exipact.org.

	ISO 9001	EXCiPACT® GMP	Classic GMP (ICH Q7 / EU GMP)
Scope	General quality management	Quality management system for materials used in pharmaceutical processes (e.g., processing aids and excipients)	GMP for APIs & drug products
Use case	R&D, process development	Biomanufacturing	Clinical & commercial drug production
Documentation	Basic QMS	Full traceability, GDP-compliant	Full batch records, validation, QA release
Audit	ISO audit	EXCiPACT-accredited 3rd-party audit	Inspected by authorities (e.g. FDA, EMA)
Regulatory fit	Not sufficient for pharma	Accepted by EMA, FDA, ANSM, etc.	Required for APIs/drug products
Examples	Tech-grade lab reagents R&D-grade CellTrypase, DENARASE…	Pharma processing aids   GMP-grade CellTrypase, excipients, cell culture media & buffers …	Late-stage and critical pharma processing aids, biologics, vaccines, APIs Eg. GMP-grade DENARASE, CAR-T cells, Comirnaty, Insulin…

To facilitate qualification and reduce implementation effort, we provide extensive regulatory support for CellTrypase. This includes:
- Product release specifications
- Comprehensive product description
- Application data for key viral vector and vaccine production cell lines, as well as iPSCs

Regulatory certificates and supporting documentation, such as:
- Certificate of Analysis (CoA)
- Safety Data Sheet (SDS)
- Animal origin-free declarations
- TSE/BSE statements
- Packaging details
- Change notifications
- Quality agreements

A Drug Master File (DMF) submission is part of our regulatory roadmap to support future global filings.

To further support implementation in regulated biopharmaceutical processes, c-LEcta will soon provide validation as well as transition guidance documents to help users switch from other cell dissociation reagents to CellTrypase with confidence.