This guide covers the procedures for identifying bacteriophage lambda used in biotechnology.

Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this guide was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.

This guide covers laboratory characterization procedures for identifying bacteriophage lambda or its DNA and assumes that the reader has basic knowledge in virology and molecular biology. Bacteriohage lambda is a temperate bacteriophage with an icosahedral hear and a single, non-contractile tail ending in a single tail fiber. The lambda genome consists of a single molecule of linear double-stranded DNA and has cohesive ends. The naturally preferred hosts is Escherichia coli K12. Hundreds of lambda variants derived from wild type lambda can be used in biotechnology and differ in genome size and genotype. These are used primarily as DNA vectors for cloning DNA fragments. Judging uncontaminated, pure lambda should be done through restriction enzyme analysis DNA characterization and the presence and identification of lambda DNA is accomplished by polymerase chain reaction. The primers used for detection of bacteriophage lambda should be chosen based on the reason for detection.

1.1 This guide covers the procedures for identifying bacteriophage lambda used in biotechnology.

1.2 There are hundreds of lambda variants that can be used for biotechnology. These lambda variants are derived from wild type lambda and differ in genome size and genotype.

1.3 If the bacteriophage lambda is to be used to construct a recombinant molecule, then the same criteria as prescribed in Section 5 should be used to characterize the newly made DNA.