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GMP Grade Solutions
for Cell Therapy

Consistent GMP products are crucial as key raw materials in cell therapy manufacturing. Adhering to regulatory guidelines, we strive to provide high-quality, safe, and reliable bioactive products for cell therapy manufacturing.

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What does GMP mean to us

What does GMP mean to us?

Providing high-quality GMP products at an affordable cost can help lower the barrier in accessing innovative medicines including cell therapies. Our new facility was designed specifically for GMP production of proteins, enzymes, activation beads, and other solutions.

Dedicated facility for manufacturing GMP grade solutions
17,000+ sq. meters dedicated to meet future supply requirements
cGMP production-preparation workshops in Class B+A cleanrooms
Up to 250L fermentation capacity to support mg to g levels of production
Fully equipped onsite QC laboratory

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Ensuring Quality in our GMP Solutions

Quality control testing throughout the entire production process starting from bulk intermediates to the final lyophilized product ensures that our GMP grade products meets your needs and remains compliant. We ensure bioactivity, consistency, and stability in all our GMP solutions through our comprehensive quality management system.

GMP Grade Cytokines – GMP IL-15 Quality Data

High purity than 90% of GMP Human IL-15
GMP-L15H13
The Cell based assay shows that GMP Human IL-15 Protein
Bioactivity Analysis of Three Lots of IL-15 GMP grade Protein

Three independent lots of GMP Human IL-15 (Cat. No. GMP-L15H13) were tested for the ability to simulate the proliferation of CTLL-2 cells. Average specific activity of GMP Human IL-15 was defined to be more than 0.8 x 107 IU/mg after calibration against human IL-15 WHO International Standard (NIBSC code: 95/554).

Find more information on our other GMP Products:

Human IL-2, GMP-grade
Human IL-7, GMP-grade
Human IL-15, GMP-grade
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GMP Grade Magnetic Beads – ActiveMax CD3/CD28 Beads Quality Data

GMP-MBS001-TDL1
GMP-MBS001-TDL2
Bioactivity Analysis of ActiveMax CD3/CD28 Beads

Human T cells were stimulated using GMP-grade ActiveMax Human T Cell Activation / Expansion CD3/CD28 beads (Cat. No. GMP-MBS001 ) for 24 hours. Activation was assessed by measuring expression of both activation markers CD25 and CD69 expression on T cell surface by staining with PE labeled anti-human CD25 antibody and FITC-labeled anti-human CD69 antibody respectively (QC tested).

Find more information on our other GMP Products:

Anti-CD3 (OKT3) Antibody, GMP-grade
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GMP Grade Recombinant Proteins – DLL4 Quality Data

GMP-DL4H23-AD1
Bioactivity Analysis of DLL4 for Stem Cell Differentiation

CD34+ CD45+ hematopoietic cells were seeded on GMP Biotinylated Human DLL4 Protein, His,Avitag (Cat. No. GMP-DL4H23) coated plates and differentiated for 14 days, then flow cytometry was used to detect the expression of T-cell progenitor markers, CD7 and CD5. The GMP Biotinylated Human DLL4 Protein, His,Avitag together with SCF, TPO, Flt3L and IL7, could induce the formation of CD7+ and CD7+ CD5+ T-cell progenitors (Routinely tested).

Find more information on our other GMP Products:

DLL4, Fc tag, GMP-grade
Biotinylated DLL4, His, Avitag, GMP-grade
VCAM-1, GMP-grade
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GMP Grade Enzymes – GENIUS Nuclease Quality Data

GMP-NUES19
GMP-NUES19-Z1
Bioactivity Analysis of Nuclease for Nucleic Acid Digestion

Specific activity for GMP GENIUS Nuclease is measured under standard assay conditions. The specific activity of GMP GENIUS Nuclease, is >1.2E+06 unit/mg protein. One unit will digest sonicated salmon sperm DNA to acid-soluble oligonucleotides equivalent to a ΔA260 of 1.0 in 30 min at pH 8.0 at 37 °C, which corresponds approximately to complete digestion of 37 μg DNA.

Find more information on our other GMP Products:

Salt-Active GENIUS Nuclease, GMP-grade
NLS-Cas9 Nuclease, GMP-grade
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a GMP grade product ?

Search our GMP Solutions by Application

Search for the solutions that fit your needs by your application! We currently offer a wide array of products designed to help with cell manufacturing of immune cells including T cells, NK cells, and Dendritic cells. We also offer an increasingly large catalog of iPSC growth factors and differentiation factors. This includes recombinant proteins such as DLL4, VCAM-1, and many others. Basement membrane extracts and extracellular matrix proteins are also available.

Search our GMP Solutions by Product Type

Know exactly what you’re looking for? Explore our catalog of solutions to find what’s right for you. Our GMP-grade solutions are manufactured under regulatory guidelines for ancillary materials in cell therapy manufacturing processes. Related Premium (Pre-GMP) grade solutions are also listed to help you find related products to help you streamline your transition to GMP.

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Product List
Molecule Source GMP Grade Catalog No. DMF Filed for GMP Grade Premium (Pre-GMP) Grade Catalog No.

*Already purchased a DMF-filed protein? Click here to apply for your DMF authorization.

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GMP Product you need?

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Considerations when Selecting GMP-grade Raw Materials for Cell Manufacturing

In this 15-minute webinar, learn about how selecting the right raw material supplier to partner with is central to ensuring end-users' primary considerations of patient safety, lot-to-lot consistency, and supply chain reliability.

How to determine when to use GMP proteins
Evaluating a supplier for quality and reliability
How to ensure a supplier can meet your needs through later stage trials
What to look for when selecting a GMP raw material supplier

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Quality Management and Regulatory Support

We are committed to developing high quality, key reagents for use in clinical studies and commercialization of cell and gene therapies. Following current pharmaceutical manufacturing practices along with more stringent quality management and release testing standards, we strive to provide our customers with the best GMP grade products. We are continuously improving our GMP quality management system to make better raw materials that meet the global regulatory requirements for cell and gene therapy manufacturing. We welcome all customer audits and regularly audit our own facilities to ensure compliance.

Explore the contents of our regulatory support files (RSF) and apply here!

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Our GMP Grade Quality Management System

Each GMP protein is manufactured and tested in a GMP-compliant facility. Our GMP quality management system was developed and maintained in accordance with relevant cGMP and GMP guidelines.

Key highlights include:

GMP-certified facility by the NMPA and EU QP
Animal-free materials, equipment, and facilities.
Material sourcing only from approved suppliers
ISO5 clean rooms and automatic filling equipment
Professional quality personnel and training programs
Batch production and control records
Equipment validation and calibration
Analytical method validation
Deviation / Change control / CAPA / OOS
Regular internal audits
In-depth stability studies
Comprehensive regulatory support files available.

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Regulatory Certifications and Guidelines for GMP Grade Raw Materials

Each GMP protein is manufactured and tested in a GMP-compliant facility. Our GMP quality management system was developed and maintained in accordance with relevant cGMP and GMP guidelines.

Designed in ISO 9001:2015 and ISO 13485:2016 certified facilities. Manufacture and QC performed under a GMP-compliant facility.
USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
USP <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
USP 〈1114〉, Microbial Control Strategies for Cell Therapy Products
Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products
ISO 20399: 2022(E), Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products.
IPRP CTWG, IPRP Reflection Paper-General Considerations for Raw Materials Used in the Manufacture of Human Cell and Gene Therapy Products
Aseptic preparation and filling in a strict B+A production environment.
PMDA (Japan) - 生物由来原料基準-厚生労働省告示第 375 号(平成 26 年 9 月 26 日)
PMDA (Japan) - 生物由来原料基準の運用について-薬食審査発 1002 第 1 号,薬食機参発 1002 第 5 号(平成 26 年 10 月 2 日)

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Safety Controls for our GMP Grade Products

Adventitious agents contaminants within the final product of cell and gene therapies are a significant point of concern. To minimize external contaminants, a strict quality control system is necessary. GMP grade products refer to several GMP guidelines outlined by regulatory agencies and are performed periodically throughout the production and quality control process.

This includes:

Host cell lines HEK293 are clearly sourced and traceable to ECACC.
HEK293 host cell line used for production has been comprehensively tested for 26 different items.
Engineered cells are also tested after construction.
Use of chemically defined medium (CDM) and serum-free /animal-origin free materials throughout the cell culture production process.
Downstream purification with a two-stage virus removal process.
Strict aseptic process verification.
Aseptic preparation and filling in a strict B+A production environment.
Pharmaceutical grade raw materials and packaging materials that have all been registered in CDE.

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Safety Controls for our GMP Grade Products

Our professional regulatory support team has experience working with therapeutic manufacturers across the globe, with customers in China, United States, South Korea, and more. CDE, FDA, and KFDA declarations have been submitted with our support. We provide the Regulatory support file documentation to assist customers at different phases of development and use for declaration requirements.

The QMS established in accordance with EU/FDA/NMPA GMP
Support for both online / offline audits
Extensive RSF regulatory support file documentation.
DMFs available for GMP products
Support for customer IND / BLA applications.

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Want to learn more about
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Frequently Asked Questions & Resources

When it comes to preparing the transition from RUO to GMP grade proteins, it can be hard to know exactly when to start switching. We answer a few of the more common questions that we get in the industry to help shed some insight about the regulatory landscape of utilizing GMP raw materials and enter the clinical phase without any worries.

Learn more about making the transition to GMP here!

1 How do you guarantee that your raw materials are suitable to produce products suitable for cell manufacturing?

Raw materials should be sourced from qualified suppliers following a pre-established supplier qualification and monitoring process. We perform annual risk assessments for raw materials used in our GMP process along with our suppliers. This encompasses visual inspections and documentation tracking of associated documents including certificates of analysis (CoA), Certificates of Origin (CoO), TSE/BSE declarations, and animal-free statements, when applicable. Before acceptance, key raw materials are always identified and validated.

2 When cell therapy manufacturers are looking for a new raw material supplier, what advice would you give them?

We advise cell therapy manufacturers to source either pharmaceutical or GMP-grade whenever possible. Our GMP-grade products are manufactured and tested in accordance with relevant international standards. * Raw material suppliers should have a certified quality management system (QMS) along with an ISO 9001 / 13485 certification. Independent audits, quality policies, and quality processes should be established to ensure quality that matches customer expectations. Cell therapy manufacturers should also perform due diligence by qualifying their suppliers through questionnaires, on-time delivery, SCAR, and other auditing activities. Documentation including certificates of analysis, certificates of origin, and other audit trail documentation should be received from each supplier and kept as records.

Cell therapy manufacturers should begin discussions with potential suppliers as soon as possible to avoid issues when entering production. Ensuring raw material suppliers have the ability to scale-up can prevent any last-minute changes that could require expensive revalidation studies.

Identifying a secondary supplier is also crucial. Although raw materials may look identical, there is no guarantee on how it behaves in your biological system. Do not assume that switching suppliers can be easily done – subsequent validation studies showing equivalence between raw materials from different suppliers is required. Identifying a secondary supplier can be an insurance policy if any issues arise with your primary supplier.

*International standards include:

USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
USP <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
USP <1114> Microbial Control Strategies for Cell Therapy Products
Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products
ISO 20399: 2022(E), Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products.
IPRP CTWG, IPRP Reflection Paper-General Considerations for Raw Materials Used in the Manufacture of Human Cell and Gene Therapy Products
PMDA (Japan) 生物由来原料基準-厚生労働省告示第 375 号(平成 26 年 9 月 26 日)
PMDA (Japan) 生物由来原料基準の運用について-薬食審査発 1002 第 1 号,薬食機参発 1002 第 5 号(平成 26 年 10 月 2 日)

3 How can using the right raw materials smooth the transition into clinical trial production?

The quality of manufactured cell and gene therapies is directly influenced by the raw materials used in their production, which, in turn, impacts the therapy’s impact and efficacy. Relevant regulations stipulate that the selection of raw materials should consider their necessity, rationality, and safety, preferably opting for materials approved for human use or meeting pharmacopoeia standards. Although safety and quality requirements for raw materials have lower priority in the initial preclinical stage, transitioning to regulatory-compliant GMP-grade materials becomes imperative during CMC or clinical conversion. This transition involves thorough testing, safety assessments, and process validation, demanding considerable time and effort.

If the same supplier is utilized, the physical properties and biological activity of premium-grade (PG) raw material ideally mirror those of GMP-grade, differing mainly in regulatory support documentation. Rigorous safety testing of materials interacting with patients is crucial, and confirming the consistency of manufacturing processes between PG and GMP materials is recommended. We ensure that both our PG and GMP products are derived from the same cell bank source, undergo strict quality control, demonstrating biological identity through extensive trials.

For clinical applications, an early shift to GMP is recommended, even during the preclinical phase, facilitating equivalence testing at a more manageable stage. Opting for an experienced supplier well-versed in quality management, protein biochemistry, analytical testing, and regulatory affairs is advantageous. Experienced suppliers aid in navigating changing regulatory environments, providing necessary documentation like a Drug Master File (DMF) to streamline regulatory processes. Audits of supplier facilities, preferably in person or online, strengthen the strategic partnership between suppliers and customers. Maintaining strict adherence to approved operating procedures, at least for three consecutive batches, ensures consistency and compliance with predetermined acceptance criteria for our PG products developed through the GMP product line.

4 How can cell therapy manufacturers bridge batches when scaling-up manufacturing?

Biological reagents are notorious when it comes to susceptibility to variability, especially cytokines and growth factors. Only after these reagents have been successfully developed and validated through multiple successive batches meeting the stringent outlined specifications, along with the establishment of a stable process and rigorous conformance assessment, can the product be moved into large-scale manufacturing and commercialized. This process forms a robust foundation in ensuring the consistency and reliability of GMP raw materials.

Furthermore, the manufacturing of products occurs within GMP facilities and under GMP quality systems, with strict control implemented through documented Standard Operating Procedures (SOPs) and trained personnel. This crucial information should be disclosed during audits. It is reasonable to request data from multiple batches to evaluate a supplier's capability to consistently produce a reproducible protein. Ideally, materials should be sampled from various batches to assess their consistency across the entire system. We identify standard batches and compare each new production batch to the established standard before releasing it to the market. This approach mitigates variability and ensures consistent product performance. Currently, we maintain excellent control over lot-to-lot differences, specifically in biological activity, within the range of 10-15%.

5 How do raw material suppliers ensure the safety of GMP products?

Safety regarding any raw materials employed in cell and gene therapy manufacturing is critical to ensure final therapeutic quality. This emphasizes the need for safety control to prevent contamination by exogenous factors. These ‘exogenous’ factors refer to inoculants, cell matrices, residual raw materials during production, bacteria, fungi, mycoplasma, and viruses.

The FDA recommendation of using the highest-quality materials means that all raw material suppliers should ensure that their materials or reagents are produced under the appropriate quality standards to mitigate any unreasonable risks to patients. This means that strict quality control of raw materials used in CGT production is a necessary measure to reduce the risk of external contamination and ensure the safety and efficacy of cell and gene therapy products. Expanding upon this requirement, the following requirements are outlined in various international pharmacopeias, including:

Source of production cell lines are clear and traceable to ECACC.
HEK293 host cells used for production after domestication and library construction is comprehensively tested (26 items).
Materials used in the upstream cell culture stage utilize: Chemical Defined Medium (CDM), Serum Free (SF), and Animal Origin Free (AOF) materials.
Downstream purification process design introduces virus removal / inactivation steps such as low pH and nanofiltration as well as verification of virus removal process using key virus removal processes. Separation columns and chromatographic media used throughout the purification process are dedicated to each project and not used in different production stages to avoid the risk of cross-contamination.
Preparation production is carried out in a strict B+A production environment.
Strict aseptic process verification throughout production.
The production of raw materials, packaging materials, and other materials utilize the best available grades available, such as using CDE medical grade raw materials and packaging materials.
Final product quality control release encompasses strict control, a total of 13~16 QC inspection items. This includes microbial inspection, exogenous factor detection, process residue detection, abnormal toxicity detection, etc. Each instrument is measured along with a defined analytical methodology, and key analytical instruments are verified by 3Q. Open audit trails should be available for critical analytical instruments.

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GMP Supplier?

Request a Custom GMP Protein

If you need a specific quote, please click on the link below to download the custom GMP-grade protein product inquiry form and fill in the specific information. After completing the information, please send an e-mail to services@acrobiosystems.com.

For a basic quote and initial technical evaluation, please leave a message below. Our technical team will evaluate the information provided and send the results to your e-mail address provided.

Still have other questions?
Our technical support team is always available to answer the questions you may have. Call us at: +1 800-810-0816 or send an e-mail to: services@acrobiosystems.com .

*  If the protein product that you are looking to customize is available on the official ACROBiosystems website (www.acrobiosystems.com), we can convert any existing protein to GMP-grade regardless of grade.

*   GMP-grade proteins can also be developed from scratch.

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