clone Stability


 

ValitaSTABILITY cuts Stability Assessment by up to 70%

    
 
       
 Normal 
 0 
 
 
 
 
 false 
 false 
 false 
 
 EN-IE 
 JA 
 X-NONE 
 
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      /* Style Definitions */
table.MsoNormalTable
	{mso-style-name:"Table Normal";
	mso-tstyle-rowband-size:0;
	mso-tstyle-colband-size:0;
	mso-style-noshow:yes;
	mso-style-priority:99;
	mso-style-parent:"";
	mso-padding-alt:0cm 5.4pt 0cm 5.4pt;
	mso-para-margin:0cm;
	mso-para-margin-bottom:.0001pt;
	mso-pagination:widow-orphan;
	font-size:12.0pt;
	font-family:Cambria;
	mso-ascii-font-family:Cambria;
	mso-ascii-theme-font:minor-latin;
	mso-hansi-font-family:Cambria;
	mso-hansi-theme-font:minor-latin;
	mso-ansi-language:EN-IE;}   ChemStress indicates clonal stability in just 24 days with fewer tests. Current methods of stability assessment involve multi-generational Subcloning, which involves subcloning the cell clone over 60-160 generations, and serial testing of igG over time (60- 160 days),  

ChemStress indicates clonal stability in just 24 days with fewer tests. Current methods of stability assessment involve multi-generational Subcloning, which involves subcloning the cell clone over 60-160 generations, and serial testing of igG over time (60- 160 days),  

 

The ValitaSTABILITY assay allows for rapid, low cost stability assessment using ChemStress Fingerprinting. In trials at industry sites we have demonstrated that ValitaSTABILITY can be used to predict a clones stability status, and thus deliver  significant benefits over existing technologies. Current methods of stability assessment involve multi-generational subcloning, which involves subcloning the same cell clone over 60-160 generations (days) with serial testing of IgG concentration over time. ValitaSTABILITY can determine clonal stability in just 24 days, through the generation of a ChemStress Fingerprint on day one and on day 24. The result is available on day 24. ValitaSTABILITY is 70% cheaper and 5 times faster than existing methods. 

 

Rapid

Determining instability in substantially shorter time than current tests

Lower Costs

Significant reduction in subcloning required.

Increased Revenue

Reduced drug development time through a shortened stability testing protocol


 

Technology Platform: ChemStress Fingerprinting

The ChemStress plate simulates the biological and environmental stresses that a cell clone encounters in a bioreactor. Each of the wells of the ChemStress 96-well plate are pre-coated with multiple small molecule chemicals, which re-create the environmental and biological stresses of the bioreactor. Each chemical has been carefully selected to challenge a particular aspect of a cell clones biochemistry. Some of these challenges include: Nutrient Starvation; Oxidative Stress; pH, Osmolarity and Toxicity. For example, Brefeldin A inhibits protein transport and is a lactone antibiotic.

How to Generate A ChemStress Fingerprint

An individual cell clone is grown in the ChemStress plate for 3 days. After exposure to the chemical stressors, clonal growth and product titre are measured in response to each of the chemical stressors. This is read on a plate reader and analysed using the Valitacell software 'ValitaAPP'. ValitaAPP performs the analysis of a cell clones growth and titre profile using product-specific algorithms. This makes up a clone's ChemStresss Fingerprint, and this fingerprint is unique to an individual cell clone or a media batch. 

1) An individual cell clone is grown in the ChemStress plate for 3 days and exposed to the numerous small molecule chemicals 2) A clones growth and productivity are measured on a plate reader 3) ValitaAPP software applies product-specific algorithms to analyse the growth and titre data and a ChemStress fingerprint is generated.