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 and costs 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.

  Preclinical GMP
Molecular weight 26.2 kDa per homodimer 26.2 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 #91/626
Measured by inhibition of proliferation of MPC-11 cells
0.6 – 2.5 x 103 IU/mg, calibrated against NIBSC #91/626
Measured by inhibition of proliferation of MPC-11 cells

Batch specific activity on CoA

Endotoxin level < 1000 EU/mg ≤ 50 EU/mg
Intended use Intended for preclinical ex vivo use. Not intended for therapeutic use. 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 for the exact expiry date.

Storage & Stability

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

Store a 100 µg/ml reconstituted cytokine solution:

• 4 weeks at 2°C to 8°C under sterile conditions after reconstitution. Store in the original container. 

• 4 months at -20°C to -80°C under sterile conditions after reconstitution. Store in 60 µl aliquots in polypropylene cryogenic vials.

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 9-0
Email:      regulatorysupport@cellgenix.com

 

In order to stay up-to-date and help improve regulatory guidance we are actively involved in many of the regulatory initiatives and discussions. We were amongst others actively involved in the discussions for the setup of Ph. Eur. General Chapter 5.2.12 and the ISO Technical Standard 20399.

 

Regulatory Resources

  • TSE certificate (available on request)
  • Regulatory Support File (available on request)
  • Request a DMF Letter of Authorization (USA only)

Publications

CERTIFICATE OF ANALYSIS

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