CellGenix® rh Activin A

GMP and Preclinical grade

CellGenix Recombinant Human Activin A reliably promotes definitive endoderm differentiation of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). It in addition maintains the undifferentiated state of ESCs and iPSCs. CellGenix rh Activin A is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.

General Information

Activin A belongs to the transforming growth factor beta (TGF-β) superfamily. It regulates a variety of biological functions, including cell proliferation, differentiation, apoptosis and wound repair.

Activin A is used in the cell and gene therapy space to promote differentiation of ESCs and iPSCs into definitive endoderm, and for the maintenance and self-renewal of pluripotent stem cells (PSCs).

GMP Grade

CellGenix GMP Recombinant Human Activin-A is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12.

Our GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.

name
CellGenix® Recombinant Human Activin A
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh Activin A
amount
Order Number
50  µg
1022-050
CellGenix® Preclinical rh Activin A
amount
Order Number
50  µg
1422-050

CellGenix® rh Activin A

Features

  • Produced in our dedicated animal-free facility
  • Compliant to USP <1043> and Ph. Eur. General Chapter 5.2.12 (GMP)

GMP & Preclinical Grade

  • Seamless transition from preclinical development to ATMP manufacturing

Applications

  • Differentiation of ESCs and iPSCs into definitive endoderm
  • Maintenance and self-renewal of PSCs

Highest GMP Quality Standard

  • High lot-to-lot consistency – save time on revalidations
  • Performance reliability – rely on consistent product performance
  • Highest purity – ensure the safety of your ATMP
  • Extremely low endotoxin levels – improve safety and reproducibility
  • Expert regulatory & technical support – rely on experience

Read more about our GMP Quality

 

Safe │ GMP Compliant │ Reliable

Technical Details

Source
Expressed in E. coli
Description

Human Activin A (also known as inhibin beta A chain), accession # P08476, Gly311-Ser426

Formulation

Lyophilized from a 0.2 µm-filtered solution containing 20 mM glycine, 150 mM sodium chloride and 3% mannitol, pH 9.5

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: Preclinical vs GMP

 PreclinicalGMP
Molecular weight26.2 kDa per homodimer26.2 kDa per homodimer
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity≥ 0.5 x 103 IU/mg, calibrated against NIBSC #91/6260.6 – 2.5 x 103 IU/mg, calibrated against NIBSC #91/626
Batch specific activity on CoA
Endotoxin level< 1000 EU/mg≤ 50 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for human in vivo application.Intended for clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions

Reconstitution

Recommended in sterile water to a final concentration of 250 µg/ml for 50 µg vials.

Shipment

Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.

Expiry

≥ 6 months from date of shipping. Please refer to Certificate of Analysis (CoA) for the exact expiry date.

Storage & Stability

Store lyophilized cytokine at -20°C to -80°C.

Avoid repeated freeze/thaw cycles.

Documents

Data

CellGenix GMP rh Activin A has an activity of 0.6 – 2.5 × 103 IU/mg

The activity of GMP rh Activin A was measured by inhibition of MPC-11 cell proliferation. It was calibrated against the WHO International Standard NIBSC #91/626.

You can find the batch specific activity on the Certificate of Analysis (CoA).

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
  • Outstanding QC support (e.g. extensive stability data)
  • The possibility to audit our production site
  • Detailed batch specific test results on our Certificates of Analysis
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9-302
Email:      regulatorysupport@cellgenix.com

 

In order to stay up-to-date with the international guidelines for raw materials, we are in constant interaction with regulatory authorities worldwide. In this regard, we amongst others helped defining the European guidelines which are outlined in the new general chapter Ph. Eur. monograph 5.2.12.

 

Regulatory Resources

Publications