Analytics - Labor Dr. Merk in Ochsenhausen, Germany
broad spectrum of physicochemical methods, analyzing characteristics, efficacy and safety of biologicals like antibodies, viral therapeutics, capsids, infectious, genomic virus particles, virus aggregates, analytical capabilities, IPCs, relese testing, process intermediates, drug substances, biological antibodies, viral therapeutics, vaccines, IPCs lab Germany, relese testing lab Germany, drug substances lab Germany, drug products lab Germany, biological antibodies lab Germany, viral therapeutics lab Germany, vaccines Labor Germany, Impurities lab Germany
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Analytical Characterization
Labor Dr. Merk & Kollegen offers a broad spectrum of analytical methods for IPC and release testing of process intermediates, drug substances or drug products of all kind of biologicals like antibodies, viral therapeutics or vaccines.
Physico-Chemical Characterization
|
Appearance (colour, clarity, visible particles)
pH
Osmolality
Extractable Volume
Viscosity
Residual Moisture
Relative Density
Droplet Size Determination
Droplet Size Determination
|
Content/Infectious Titer/Potency
|
Genomic Titer
Total Number Of Virus Particles/Capsids
Infectious Titer (TCID50)
Relative Potency Determination
|
Purity
|
Protein Pattern
Aggregate Formation
|
Impurities
|
Host Cell Proteins
Host Cell DNA
Residual Benzonase
Residual Formaldehyde
Residual Aluminium
Empty Virus Particles
|
Safety
|
Endotoxin
Bioburden
Sterility
Mycoplasma
Mycobacteria
Adventitious Viruses
|
Our expert teams work in close cooperation with our clients to find optimal solutions for analytical demands. With their long lasting experience in analysis of biologicals, Labor Dr. Merk & Kollegen designs the most effective study for the clients, which comply with the latest regulatory requirements (e.g. ISO, EP, ASTM, US-FDA).
Protein Biochemestry
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Molecular Biology
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Immunological Assays
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Nanoparticle Tracking Analysis
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Residual DNA Analysis
Labor Dr. Merk & Kollegen offers a broad spectrum of analytical methods for IPC and release testing of process intermediates, drug substances or drug products of all kind of biologicals like antibodies, viral therapeutics or vaccines.
Physico-Chemical Characterization
|
Appearance (colour, clarity, visible particles)
pH
Osmolality
Extractable Volume
Viscosity
Residual Moisture
Relative Density
Droplet Size Determination
Droplet Size Determination
|
Content/Infectious Titer/Potency
|
Genomic Titer
Total Number Of Virus Particles/Capsids
Infectious Titer (TCID50)
Relative Potency Determination
|
Purity
|
Protein Pattern
Aggregate Formation
|
Impurities
|
Host Cell Proteins
Host Cell DNA
Residual Benzonase
Residual Formaldehyde
Residual Aluminium
Empty Virus Particles
|
Safety
|
Endotoxin
Bioburden
Sterility
Mycoplasma
Mycobacteria
Adventitious Viruses
|
Our expert teams work in close cooperation with our clients to find optimal solutions for analytical demands. With their long lasting experience in analysis of biologicals, Labor Dr. Merk & Kollegen designs the most effective study for the clients, which comply with the latest regulatory requirements (e.g. ISO, EP, ASTM, US-FDA).