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 제품안내  세포배양   Stem Cell

GMP Grade Small Molecules

세포 치료제에 이용할 수 있는 GMP Grade Small Molecule을 소개합니다. 현재 판매 가능한 Stem cell small molecule에 대한 정보도 만나보세요.

TOCRIS
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TOCRIS GMP Grade Small Molecule의 장점

  • ICH 가이드라인에 따른 GMP process 
  • 품질 보증된 제조시스템 
  • 바이오 제품에 비해 순도가 높고, 배치간 일관성 보장 
  • Starting 물질에서 final product까지의 추적 
  • Animal free production 
  • Unwanted exogenous gene expression 위험으로부터 안전 


TOCRIS GMP Grade Small Molecule의 종류

     Reprogramming Adult (Somatic) Cells to iPSCs

  CHIR 99021 (GSK-3 Inhibitor)
  SB 431542 (TGF-b1 & ALK 4/7 Inhibitor)
           
     Stem Cell Proliferation and Maintenance
  Y-27632 (ROCK Inhibitor)
           
     Differentiation of iPSCs
  CHIR 99021 (GSK-3 Inhibitor)
  XAV 939 (Tankyrase Inhibitor)
  SB 431542 (TGF-b1 & ALK 4/7 Inhibitor)
  DAPT ( γ-secretase Inhibitor)


  


TOCRIS GMP Grade Small Molecule에 대하여

  cGMP Quality

The quality of stem cell therapies and other ATMPs (Advanced Therapy Medicinal Products) depend on the quality and safety of raw materials / ancillary reagents. It is best practice for these to adhere to cGMP specifications when being used for the development of stem cell therapies and other ATMPs. The Tocris range of cGMP small molecules is manufactured following relevant sections of ICH Q7 guidelines (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).

Our highly skilled team have full control over the cGMP process, meaning we can ensure from the outset:
•Batch-to-batch consistency
•Traceability from starting material to final product
•Animal-free production

 

  Safety

Safety considerations are of high importance when developing stem cell therapies and other ATMPs for use in the clinic. Our cGMP small molecules are classified tier 2 risk as per USP .

USP : Ancillary Materials for Cell, Gene, and Tissue-Engineered Products

AM Risk Tier 2: Low-Risk, Well Characterized Materials with Intended use as AMs, Produced in Compliance with cGMPs.

To ensure the safety of your stem cell therapy, we can ensure:
•Traceability from starting materials to final product
•Fully qualified vendors of raw materials for our production processes
•Animal-free production
•Endotoxin and bioburden tested compounds
•Stringent QC testing
  Security of Supply

It is vital to have a consistent and reliable supply of cGMP raw materials when developing ATMPs such as stem cell therapies. Any delay or quality issue can result in significant issues, including increased cost and risk to patient samples. At Tocris we are well known for our consistent and reliable resupply and can offer you:
•Consistent and assured supply of cGMP materials
•Supply agreements and batch reservations
•A point of contact at all times throughout your development process
•Ability to scale up

 

  Stringent QA and QC

To ensure the highest quality our cGMP compounds are synthesized under a quality assured manufacturing system and subjected to stringent quality control.

Analytical Tests:
•Purity - HPLC
•Product identification - NMR and Mass Spectrometry
•Water content - Karl Fischer
•Residue on Ignition
•Residual solvents
•Solubility

Microbiological Tests:
•Bioburden
•Endotoxin

Product Specific Documentation:
•Certificate of Analysis (CofA)
•Safety Data Sheet (SDS)
•TSE/BSE statement (Transmissible Spongiform Encephalopathy / Bovine Spongiform Encephalopathy)
•Product Specifications

These documents are available on request.

 

  Transition from Pre-clinical to Cell Therapy

An important consideration when developing a cell therapy is when to transition raw materials from research use only (RUO) to cGMP. Although the quality and safety of raw materials is less important during the pre-clinical stages of development, the cost and freedom of change increases and decreases respectively, as the clinical phase of development is advanced. We would recommend identifying a reliable supplier of your required cGMP raw materials early in the preclinical development stage, and transitioning from RUO to cGMP as early as possible during development. This will avoid the need to conduct time-consuming and expensive comparative studies during the latter stages of clinical development.

 

  Regulatory Support

We offer the following regulatory support on request for our cGMP product line:
•Auditing of our manufacturing facility (we are based in Bristol, UK)
•Change notifications
•Additional product data

 

  FAQs:

What is the difference between RUO and cGMP small molecules?
Our cGMP small molecules are manufactured following relevant sections of ICH Q7 guidelines. They are also categorized in the risk tier 2 classification (low risk, well characterized materials with intended use as AMs, produced in compliance with cGMP) of USP . Our RUO products, along with the RUO products of other suppliers, are categorized in the risk tier 3 classification (moderate-risk materials not intended for use as AMs) of USP .

Each vial is weighed to a precise and specific amount. The appropriate volume of solvent can be injected directly through the septum into the vial. We would recommend passing the solution through a 0.2 μm filter.
We also carry out microbiological testing on our cGMP small molecules, specifically endotoxin and bioburden testing.

Are cGMP small molecules animal free?
Yes, our cGMP small molecules are animal free

Can cGMP small molecules be used as therapeutics?
No, our cGMP small molecules should only be used as raw materials / ancillary reagents for further ATMP manufacture, such as stem cell therapies.
  Why has Tocris developed a cGMP product line?
Stem cell therapies are beginning to enter the clinic. As the clinical phases of cell therapy development are highly regulated, there is now a requirement to use cGMP compounds as ancillary reagents, to ensure the safety, suitability and reduced risk of the stem cell therapy being developed. By introducing a cGMP product line, Tocris is fulfilling its commitment to provide the life science community with the latest and most relevant reagents available, to make new discoveries possible.