Biosafety for Biological Therapeutics

DOL is one of the few companies globally with actual clinical experience.
Biosafety for Biological Therapeutics

Biosafety for Biological Therapeutics

For all types of biological therapies a significant safety risk is posed by adventitious agents if present. Contaminants can originate from multiple and diverse sources so there is a need for all materials, cell lines, primary cells, and tissue products used for therapeutic purposes to be tested for a range of adventitious agents. DOL has extensive experience manufacturing cell therapies under GMP conditions and understands the strict requirements for ensuring a cell product meets regulatory standards. DOL is able to provide the following services:

  • Testing for contaminating Mycoplasma by detection of Mycoplasma DNA using validated PCR.
  • Testing for contaminating Bacteria via aerobic and anaerobic culture.
  • Testing for Retroviruses by qualitative or quantitative detection of reverse transcriptase activity.
  • Testing for contaminating Viruses (known and unknown) by coculture of primary tissue (fresh or cultured) and viral controls with a panel of appropriate indicator cells.
  • Testing for lentiviral vector contamination in CAR T-cell therapies by ELISA detection of the HIV-1 p24 antigen.

We are familiar with diverse regulatory requirements and the practical realities of xeno-related testing.

DOL can provide the following assistance to clients:

  • Secure, monitored, alarmed and Quality controlled storage for archiving of patient tissues.

  • Supply of donor materials (islets and other) derived from a FDA approved herd.

  • Consultation regarding strategy for pre-clinical and clinical programs

  • Consultation regarding islet procurement and manufacture under GMP.

  • High throughput nucleic acid extraction services for a variety of sample types. We produce high purity DNA and RNA for analysis from human and animal samples which can be used for genotyping, library construction, PCR, Southern blotting and other molecular biology applications.

  • Developing and validation of new PCR methods for detection of both animal and human pathogens.

Please contact us with any requests or if you wish to discuss the nature of your project further.