Viral Safety and Clearance Services

For all stages throughout the development, manufacturing and release of your biological product, we offer comprehensive, fully cGMP-compliant viral safety and clearance services.

Why Lancaster Laboratories?

• All of our assays are fully validated to meet ICH Q2 requirements.
• With more than 20 years of viral experience, our technical staff provides you with the technical advice to ensure that your study design and execution is in compliance with FDA, ICH and EU Guidelines for Viral Safety Evaluation.
• You get access to multiple dedicated clearance suites for an extensive capacity and timely execution and reporting of your study results.
• In addition to our Virology services, you get seamless transition to any supporting services you may require, such as Microbiology, and Molecular and Cell Biology, and storage—all fully-cGMP compliant.

Leadership of Group:

Testing Available
Viral Safety
Viral Clearance

Viral Safety

Lancaster Laboratories offers comprehensive viral safety services that are available for:

• Characterization of Cell Banks
• Unprocessed Bulk Testing
• End of Production Cells
• Raw Materials Testing

Available viral assays (all assays performed in-house are fully validated according to ICH Q2):

• Adventitious Viruses
  • In Vitro Assays
    • Multiple cell lines are available for Mouse, Hamster and Human derived products
  • In Vivo Assays
• Specific Viruses
  • Bovine Viral Assay according to 9 CFR 113
  • Porcine Viral Assay according to 9 CFR 113
• Retrovirus Assays
  • XC Assay for Ecotropic Retroviruses
  • S+L- Assay
  • Electron Microscopy
• Antibody Production Tests
  • Mouse Antibody Production (MAP)
  • Hamster Antibody Production (HAP)
  • Rat Antibody Production (RAP)

Facilities and Equipment

• Segregated virology and cell-culture laboratories.
• HEPA filtered laboratories maintained at differential pressure for isolation and control.
• Validated cleaning disinfection and environmental monitoring programs.
• Multiple biological safety cabinets capable of handling BSL2 materials.

Viral Clearance

With more than 20 years of viral clearance experience, our staff provides consulting to validate your purification process. Services and facilities are cGMP-compliant and include multiple clearance suites for client use, controlled laboratories and validated assays. Our project management can assist you in the design of studies that meet regulatory requirements.

An example protocol and report for a Phase I clearance study is available upon request. Click here to learn more.

• Variety of validated viral stocks available to support animal and human derived products.
• Viral stocks with titers of 10⁷ pfu/ml or greater.
• Validated qPCR assays available for selected viruses.
• Infectivity assays performed real time.

Facilities and Equipment

• Multiple HEPA filtered virus clearance labs for client use.
• Multiple AKTA chromatography systems for client use.
• Manual chromatography equipment available.
• Capacity to accommodate studies with minimal delay.

Contact

Request additional information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.