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Analytical Method Development

Analytical Method Development

 

Mycenax offers comprehensive analytical development services for biopharmaceutical, supporting every phase of the project lifecycle. Our expertise spans method development, validation, characterization, and stability testing, utilizing advanced techniques. We ensure the success of your biopharmaceutical program with tailored, high-quality solutions.

 

Mycenax provides a one-stop service, offering a wide range of analytical services tailored to biologics development. Our analytical teams have expertise in antibodies (IgG1, IgG2, IgG4, and multi-specific antibodies), enzymes, recombinant proteins, ADCs, mRNA, stem cells, and exosomes. At Mycenax, the validated methods comply with ICH Q2 (R2) guidelines, ensuring consistent and reproducible results.

 

The key features of our services are as follows:

◆

  

End-to-end solutions and phase-specific approach

◆

  

Analytical services for a wide variety of biopharmaceutical

◆

  

Full in-house analytical capabilities for lot release and product characterization

 

      
 
 
 

Tailored Analytical Solutions with State-of-the-Art Facilities
 

With state-of-the-art facilities such as SoloVPE, Maurice systems, Mycenax provides tailored analytical solutions that reduce the variation and increase the reproducibility. In addition to common physicochemical analysis equipment, such as DLS, CD, and others, we also use mass spectrometry to examine the sequence and modifications, and Biacore to assess the binding affinity between the ligand and analyte.
 
 
           
 
 

 
                                 
                                 
  General Analysis       Product-Related Purity/Impurity       Process-Related Purity/Impurity  

 

 ◆   Appearance       ◆   CE-SDS       ◆   HCP  

 

 ◆   pH       ◆   cIEF/icIEF       ◆   HCDNA  

 

 ◆   Protein Concentration       ◆   SE-HPLC/UPLC       ◆   Residual Protein A  

 

 ◆   Osmolality       ◆   IEX-HPLC/UPLC       ◆   Residual Impurity  

 

 ◆   Viscosity       ◆   HIC-HPLC/UPLC              

 

 ◆   Water Content       ◆   RP-HPLC/UPLC              

 

 ◆   Sub-visible Particles (HIAC, FlowCAM)                          
                                 
                     
                                 
  Potency       Contaminant Content       Primary Structure  

 

 ◆  

SPR

       ◆  

Endotoxin

       ◆  

DNA Sequencing

  

 

 ◆  

ADCC

       ◆  

Microbial Enumeration

       ◆  

Amino Acid Sequencing

  

 

 ◆  

CDC

       ◆  

Sterility

       ◆  

Peptide Mapping

  

 

 ◆  

Binding Activity (ELISA)

                   ◆  

Amino Acid Composition

  

 

 ◆  

Enzyme Activity

                   ◆   Edman Degradation  

 

 ◆  

Cell-Based Assay

                          

 

                                
                                 
                     
                                 
  Advanced Structure       Post-Translational Modification       Exosome  

 

 ◆  

DLS

       ◆  

Disulfide Bond Linkage

       ◆  

NTA

  

 

 ◆  

DSC

       ◆  

Glycosylation

       ◆  

NanoFCM

  

 

 ◆  

CD Spectra

       ◆  

Deamidation

       ◆  

Western Blot

  

 

 ◆  

AUC

       ◆  

Oxidation

       ◆  

Cell-Based Assay

  

 

 ◆  

SEC-MALS

       ◆  

Pyro-E

              

 

             ◆  

K-Clipping

              

 

             ◆   Carbamylation              
                                 
 
                                 
  Cell Therapy Related       ADC Related       Plasmid  

 

 ◆  

Flow Cytometry

       ◆  

Drug Antibody Ratio (DAR) via Absorbance, Ellman, HIC-HPLC, RP-HPLC

       ◆  

DNA Content

  

 

 ◆  

Phenotyping Assay

       ◆  

Residual Drug-Related Substance

       ◆  

Supercoil pDNA Purity

  

 

 ◆  

Trilineage Differentiation

       ◆  

Residual Solvent (DMSO, DMF, etc.)

       ◆  

Host Cell RNA Residue

  

 

 ◆  

Cytotoxicity Assay

                          

 

 ◆  

Immunosuppressive Activity

                          

 

 ◆  

IDO Detection

                          

 

                                
                                 

 

 

Mycenax offers comprehensive analytical development services for biopharmaceutical, supporting every phase of the project lifecycle. Our expertise spans method development, validation, characterization, and stability testing, utilizing advanced techniques. We ensure the success of your biopharmaceutical program with tailored, high-quality solutions.

 

Mycenax provides a one-stop service, offering a wide range of analytical services tailored to biologics development. Our analytical teams have expertise in antibodies (IgG1, IgG2, IgG4, and multi-specific antibodies), enzymes, recombinant proteins, ADCs, mRNA, stem cells, and exosomes. At Mycenax, the validated methods comply with ICH Q2 (R2) guidelines, ensuring consistent and reproducible results.

 

The key features of our services are as follows:

◆

  

End-to-end solutions and phase-specific approach

◆

  

Analytical services for a wide variety of biopharmaceutical

◆

  

Full in-house analytical capabilities for lot release and product characterization

 

    
 
 
 
 
 
 
 
 
 

Tailored Analytical Solutions with State-of-the-Art Facilities
 

With state-of-the-art facilities such as SoloVPE, Maurice systems, Mycenax provides tailored analytical solutions that reduce the variation and increase the reproducibility. In addition to common physicochemical analysis equipment, such as DLS, CD, and others, we also use mass spectrometry to examine the sequence and modifications, and Biacore to assess the binding affinity between the ligand and analyte.
 
 
 
 
 

 
 
       
  General Analysis

 

 ◆   Appearance

 

 ◆   pH

 

 ◆   Protein Concentration

 

 ◆   Osmolality

 

 ◆   Viscosity

 

 ◆   Water Content

 

 ◆   Sub-visible Particles (HIAC, FlowCAM)
       

 

       
  Product-Related Purity/Impurity
  ◆   CE-SDS
  ◆   cIEF/icIEF
  ◆   SE-HPLC/UPLC
  ◆   IEX-HPLC/UPLC
  ◆   HIC-HPLC/UPLC
  ◆   RP-HPLC/UPLC
       

 

       
  Process-Related Purity/Impurity
  ◆   HCP
  ◆   HCDNA
  ◆   Residual Protein A
  ◆   Residual Impurity
       

 

       
  Potency

 

 ◆  

SPR

 

 ◆  

ADCC

 

 ◆  

CDC

 

 ◆  

Binding Activity (ELISA)

 

 ◆  

Enzyme Activity

 

 ◆  

Cell-Based Assay

 

      

 

       
  Contaminant Content
  ◆  

Endotoxin
  ◆  

Microbial Enumeration
  ◆  

Sterility
       

 

       
  Primary Structure
  ◆  

DNA Sequencing
  ◆  

Amino Acid Sequencing
  ◆  

Peptide Mapping
  ◆  

Amino Acid Composition
  ◆   Edman Degradation
       

 

       
  Advanced Structure

 

 ◆  

DLS

 

 ◆  

DSC

 

 ◆  

CD Spectra

 

 ◆  

AUC

 

 ◆  

SEC-MALS

 

      

 

       
  Post-Translational Modification
  ◆  

Disulfide Bond Linkage
  ◆  

Glycosylation
  ◆  

Deamidation
  ◆  

Oxidation
  ◆  

Pyro-E
  ◆  

K-Clipping
  ◆   Carbamylation
       

 

       
  Exosome
  ◆  

NTA
  ◆  

NanoFCM
  ◆  

Western Blot
  ◆  

Cell-Based Assay
       

 

       
  Cell Therapy Related

 

 ◆  

Flow Cytometry

 

 ◆  

Phenotyping Assay

 

 ◆  

Trilineage Differentiation

 

 ◆  

Cytotoxicity Assay

 

 ◆  

Immunosuppressive Activity

 

 ◆  

IDO Detection

 

      

 

       
  ADC Related
 

◆

  

Drug Antibody Ratio (DAR) via Absorbance, Ellman, HIC-HPLC, RP-HPLC
  ◆  

Residual Drug-Related Substance
  ◆  

Residual Solvent (DMSO, DMF, etc.)
       

 

       
  Plasmid
  ◆  

DNA Content
  ◆  

Supercoil pDNA Purity
  ◆  

Host Cell RNA Residue
       
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