Beim Braunland 1 88416 Ochsenhausen |
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Viral Clearance Studies
Labor Dr. Merk & Kollegen supports leading biopharma and biotech companies by determining the virus eliminating or inactivating capacity of viral clearance processes for any known or unknown viral contamination.
The process validation and the determination of its relative efficiency by Labor Dr. Merk & Kollegen, ensures the maintenance of the highest standards, increases process efficiency and cuts overall costs for the customer. More than 40 virus strains of human and animal origin with different physicochemical properties are available for validation of manufacturing steps for virus clearance, testing of substances for antiviral efficacy or extraneous agent testing of materials of animal origin.
Examples of model viruses:
Virus |
Family |
Structure |
Genome
|
Size (nm)
|
Resistance
|
|---|---|---|---|---|---|
Murine Retrovirus (MuLV) |
Retroviridae |
enveloped |
ss-RNA |
80-110 |
Low |
Minute Virus of Mice (MVM) |
Parvoviridae |
non-enveloped |
ss-RNA |
18-24 |
Very high |
Porcine Parvovirus |
Parvoviridae |
non-enveloped |
ss-RNA |
18-24 |
Very high |
Reovirus Type 3 |
Reoviridae |
non-enveloped |
ds-RNA |
60-80 |
Medium |
Pseudorabies Virus (PRV) |
Herpesviridae |
enveloped |
ds-RNA |
120-200 |
Medium |
Sindbis Virus |
Togaviridae |
enveloped |
ss-RNA |
60-70 |
Low |
Parainfluenza Virus Type 3 |
Paramyxoviridae |
enveloped |
ss-RNA |
100-200 |
Medium-Low |
WHY LMK
At Labor Dr. Merk & Kollegen we combine over 40 years of experience with the know-how of leading virologists. Our expert team communicates with regulatory agencies to design the most effective studies for the clients, which comply with the latest regulatory requirements (e.g. ISO, EP, US-FDA).
Disinfectant Studies
The antiviral efficacy of disinfectants or disinfectant candidates for human and veterinary use is tested by Labor Dr. Merk & Kollegen expert teams that possess the necessary skills, experience and knowledge. In compliance with national and international standards and guidelines, tests can be performed on adherent or suspension cell lines, on inanimate surfaces or even on synthetic skin materials. All methods necessary to fulfill the guidelines for testing disinfectants for hands, surfaces or instruments in suspension tests (phase 2/step 1) and more practical applications (phase 2/step 2) are available.
As a member of the expert committee “virus disinfection” of the DVV (German Association for the Control of Virus Diseases), Labor Dr. Merk & Kollegen communicates with regulatory agencies to design the most effective studies for the clients, which comply with the latest regulatory requirements.
> Guideline of „Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V.“ (DVV; German Association for the Control of Virus Diseases) and Robert Koch Institute (RKI; German Federal Health Authority) for testing the virucidal efficacity of chemical disinfectants in the human medical area
> Guideline of „Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V.“ (DVV; German Association for the Control of Virus Diseases) Quantitative test for the evaluation of virucidal activity of chemical disinfectants on non-porous surfaces (for use in human medicine)
> Guideline of DVG (Deutsche veterinärmedizinische Gesellschaft): Richtlinie für die Prüfung von Desinfektionsverfahren und chemische Desinfektionsmitteln
> EN 14476: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test method and requirements (Phase 2/Step 1)
> EN 14675: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area – Test method and requirements (Phase 2, step 1)
> EN 16777: Chemical disinfectants and antiseptics – Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area – Test method and requirements (phase 2/step 2)
> EN 17111: Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of virucidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2)
Raw Material Testing
What
Combining our proven skill, know-how and experience our dedicated project teams are experts at testing for adventitious viral agents. Be it on raw materials, final products, medical devices, pharmaceuticals, diagnostic antigens or hospital waste – we’ll help you to ensure safe usage of your product.
How
All studies are performed according to the European Pharmacopoeia and in accordance with national and international guidelines or even under GMP for special applications:
> Ph Eur 2.6.16 Tests for extraneous agents in viral vaccines
> Ph Eur 5.2.3 Testing of cell substrates for the production of vaccines for human use
> EMEA/CPMP/BWP/1793/02 Note for guidance on the use of bovine serum in the manufacture of human biological medicinal products
> EMEA/CVMP/743/00-Rev.2 Guideline on requirements and control and controls applied to bovine serum used in the production of immunological veterinary medicinal products
> EMEA/CPMP/BWP/3354/99 Note for guidance on production and quality control of animal immunoglobulins and immunosera for human use
More than 40 human and animal pathogenic enveloped and non-enveloped viruses with different physicochemical properties are available for validation of manufacturing steps for viral clearance, testing of substances for antiviral activity or extraneous agent testing of materials of animal or cell culture origin.
Why LMK
At LMK we combine over 20 years of tried and tested experience with the know-how of leading virologists. Also, the fact that we are able to deliver viral expertise from virus cultivation to purification and analysis with several different human and animal pathogenic viruses allows us to customize our tests and easily cater to individual wishes.
Viral Antigen-/ Vaccine Production
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Viral Clearance Studies
Labor Dr. Merk & Kollegen supports leading biopharma and biotech companies by determining the virus eliminating or inactivating capacity of viral clearance processes for any known or unknown viral contamination.
The process validation and the determination of its relative efficiency by Labor Dr. Merk & Kollegen, ensures the maintenance of the highest standards, increases process efficiency and cuts overall costs for the customer. More than 40 virus strains of human and animal origin with different physicochemical properties are available for validation of manufacturing steps for virus clearance, testing of substances for antiviral efficacy or extraneous agent testing of materials of animal origin.
Examples of model viruses:
Virus |
Family |
Structure |
Genome
|
Size (nm)
|
Resistance
|
|---|---|---|---|---|---|
Murine Retrovirus (MuLV) |
Retroviridae |
enveloped |
ss-RNA |
80-110 |
Low |
Minute Virus of Mice (MVM) |
Parvoviridae |
non-enveloped |
ss-RNA |
18-24 |
Very high |
Porcine Parvovirus |
Parvoviridae |
non-enveloped |
ss-RNA |
18-24 |
Very high |
Reovirus Type 3 |
Reoviridae |
non-enveloped |
ds-RNA |
60-80 |
Medium |
Pseudorabies Virus (PRV) |
Herpesviridae |
enveloped |
ds-RNA |
120-200 |
Medium |
Sindbis Virus |
Togaviridae |
enveloped |
ss-RNA |
60-70 |
Low |
Parainfluenza Virus Type 3 |
Paramyxoviridae |
enveloped |
ss-RNA |
100-200 |
Medium-Low |
WHY LMK
At Labor Dr. Merk & Kollegen we combine over 40 years of experience with the know-how of leading virologists. Our expert team communicates with regulatory agencies to design the most effective studies for the clients, which comply with the latest regulatory requirements (e.g. ISO, EP, US-FDA).
Disinfectant Studies
The antiviral efficacy of disinfectants or disinfectant candidates for human and veterinary use is tested by Labor Dr. Merk & Kollegen expert teams that possess the necessary skills, experience and knowledge. In compliance with national and international standards and guidelines, tests can be performed on adherent or suspension cell lines, on inanimate surfaces or even on synthetic skin materials. All methods necessary to fulfill the guidelines for testing disinfectants for hands, surfaces or instruments in suspension tests (phase 2/step 1) and more practical applications (phase 2/step 2) are available.
As a member of the expert committee “virus disinfection” of the DVV (German Association for the Control of Virus Diseases), Labor Dr. Merk & Kollegen communicates with regulatory agencies to design the most effective studies for the clients, which comply with the latest regulatory requirements.
> Guideline of „Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V.“ (DVV; German Association for the Control of Virus Diseases) and Robert Koch Institute (RKI; German Federal Health Authority) for testing the virucidal efficacity of chemical disinfectants in the human medical area
> Guideline of „Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V.“ (DVV; German Association for the Control of Virus Diseases) Quantitative test for the evaluation of virucidal activity of chemical disinfectants on non-porous surfaces (for use in human medicine)
> Guideline of DVG (Deutsche veterinärmedizinische Gesellschaft): Richtlinie für die Prüfung von Desinfektionsverfahren und chemische Desinfektionsmitteln
> EN 14476: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test method and requirements (Phase 2/Step 1)
> EN 14675: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area – Test method and requirements (Phase 2, step 1)
> EN 16777: Chemical disinfectants and antiseptics – Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area – Test method and requirements (phase 2/step 2)