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Inactivation / Clearance Validation Studies 

INACTIVATION OR REMOVAL STUDIES FOR
VIRUS, BACTERIA, MYCOPLASMA, DNA AND ENDOTOXIN 

AppTec offers custom studies to validate removal, inactivation, or cleaning processes for viruses, bacteria, and mycoplasma agents, with studies performed for R&D, GLP or GMP as needed.  Our scientific and quality teams have comprehensive expertise in virology, microbiology, infectivity and quantitative PCR assays, process development, and international regulatory considerations for early- and late-stage products. 

Clearance studies have broad application for Phase 1-3, BLA and 510K submissions for:

  ·    Monoclonal antibodies

  ·    Tissues (bone, skin, collagen, heart valves)

  ·    Blood

  ·    Gene therapy vectors

  ·    Viral vaccines

  ·    Other expressed proteins 

Multi-Step Validations & Cleaning Analyses 

INACTIVATION

  ·    Heat / Pasteurization

  ·    Low pH

  ·    Solvent / Detergent

  ·    Irradiation

  ·    Sterilization

  ·    High Energy Light

  ·    Ethanol 

REMOVAL

  ·    Column Chromatography

  ·    Cohn Fractionation

  ·    Filtration

  ·    Specialized viral / microbial devices  

Dedicated Laboratories

  ·    6 BSL-2 and 2 BSL-3 client labs for process performance

  ·    Viral, microbial & mycoplasma culture rooms

  ·    Molecular biology suites for Real Time PCR analyses

  ·    Analytical labs for routine analysis  

Real Time Quantitative PCR

qPCRs are available for a wide range of viruses to complement standard viral titration assays.[The PCR (Polymerase Chain Reaction) tests are performed pursuant to an agreement with Roche Molecular Systems, Inc.]  

Characterization of Virus Stocks

Viruses were selected by triple plaque purification or limit–dilution, and master and working seed stocks were prepared.  All seed stocks and subsequent production lots have been analyzed for identity and tested for microbial and bovine or porcine viral contaminants.         

Purification of Viruses

Some of the viruses for viral clearance are available as column or filter-resin purified and treated to remove or reduce contaminating cell nucleic acid for sensitive processing steps, such as nano-filters and some column chromatography steps.    

Microorganism Availability

A variety of microbial agents can be assessed for removal or inactivation.

See list below for a partial menu of available microorganisms. 

In addition, specific microorganisms can be assayed as needed by clients.  

VIRUSES

Adenovirus type 5

Amphotropic murine leukemia virus

Bovine parainfluenza virus

Bovine parvovirus

Bovine viral diarrhea virus

Cytomegalovirus

Duck hepatitis B virus

Encephalomyocarditis virus

Hepatitis A virus

Human immunodeficiency virus type 1

Herpes simplex virus type 1

Infectious bovine rhinotracheitis virus

Influenza A virus

Minute virus of mice

Poliovirus type 1

Porcine parvovirus

Pseudorabies virus

Reovirus type 3

Simian virus type 40

Transmissible gastroenteritis virus

Vesicular stomatits virus

West Nile virus (NY-99 strain)

Xenotropic murine leukemia virus 

TSE AGENT

Transmissible spongiform encephalopathy(TSE) agent

          • 263K Hamster Strain 

BACTERIA, FUNGI, AND MYCOPLASMA

A. niger

B. subtilis

C. albicans

C. sporogenes

M. hyorhinis GDL

M. orale JS

M. pneumoniae FH

M. arginini

M. gallisepticum

P. aeruginosa

S. aureus