ASTM E1493-06

Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)

SIGNIFICANCE AND USE
This guide is intended for use in a biotechnology laboratory when the need arises to identify a preparation containing M13 bacteriophage or DNA.
SCOPE
1.1 This guide covers the identification of bacteriophage M13 used in biotechnology.
1.2 There are many variants of M13 that have been developed specifically for cloning technology. These variants have foreign DNA inserted into the M13 genome, causing the M13 to differ in size and genotype.
1.3 If the M13 is to be used to construct a recombinant molecule, then the criteria described in Section 6 should be used to characterize the newly made DNA.
WITHDRAWN RATIONALE
This guide covers the identification of bacteriophage M13 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Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this guide was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2006
• Withdrawal Date: 04-Aug-2014
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.04 - General Biopharmaceutical Standards

Relations

• Replaces: ASTM E1493-01 - Standard Guide for Identification of Bacteriophage M13 or Its DNA
• Effective Date: 01-Nov-2006
• Referred By: ASTM E2363-23 - Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
• Effective Date: 01-Nov-2006

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E1493 −06
StandardGuide for
1
Identification of Bacteriophage M13 or Its DNA
This standard is issued under the fixed designation E1493; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This guide covers the identification of bacteriophage M13 or its DNAand was developed by Task
Group E48.02.03 on viruses. The objective is to describe laboratory characterization procedures that
would be sufficient to verify that a biological preparation believed to contain M13 (or M13 DNA) for
use in any step of a biotechnology process actually does contain this bacteriophage (or its DNA).
This guide assumes a basic knowledge of microbiology and molecular biology.
1. Scope 2.1.7 phage display—the use of bacteriophage M13 or a
variant to insert a peptide sequence fused to a coat protein of
1.1 This guide covers the identification of bacteriophage
M13.
M13 used in biotechnology.
3. Significance and Use
1.2 There are many variants of M13 that have been devel-
oped specifically for cloning technology. These variants have
3.1 This guide is intended for use in a biotechnology
foreign DNAinserted into the M13 genome, causing the M13
laboratory when the need arises to identify a preparation
to differ in size and genotype.
containing M13 bacteriophage or DNA.
1.3 If the M13 is to be used to construct a recombinant
4. Background Information about M13 Bacteriophage
molecule, then the criteria described in Section 6 should be
used to characterize the newly made DNA. 4.1 M13 is a filamentous bacteriophage that infects male
+ 1
(F,F or Hfr) Escherichia coli. The phage particles contain
2. Terminology
circular single-stranded DNA, 6407 nucleotides in length,
2
2.1 Definitions: coated with the protein product of the M13 gene 8. (1)
2.1.1 alpha complementation—the ability of a short amino-
4.2 ThephageattachestoareceptorattheendoftheFpilus.
terminal fragment (alpha fragment) of β-galactosidase to form
The infecting single-stranded DNA(+strand) replicates in the
a functional complex with the carboxyl terminal fragment
cell: a complementary (−) strand is synthesized, resulting in a
(omega fragment).
double-stranded, replicative form (RF). Using the RF as a
1
2.1.2 F —an F factor that contains a portion of the E. coli template, both strands can be replicated, increasing the copy
genome.
number of the RF to about 20 to 40 per cell. Late in infection
+
(+) strands are preferentially produced and packaged into
2.1.3 F factor—an episome of E. coli. Encoded on it are
phage particles for export from the cell. (1)
the functions necessary to produce an F pilus.
4.3 M13infectionandsubsequentphagereleaseisnotlethal
2.1.4 F pilus—a protrusion on E. coli that is necessary for
to Escherichia coli. Bacteriophage DNA is continually repli-
mating. The F pilus also contains the receptor for phage M13.
+ cated and packaged, causing a decrease in the growth rate of
2.1.5 Hfr—a strain of E. coli in which the F factor is
thehost.The“plaque”seenuponinfectionbyM13istheresult
inserted into the chromosome.
of an area of decreased growth rate, not actually cell killing.
2.1.6 multiple cloning site—DNAthat contains several con-
(1)
tiguous restriction enzyme recognition sites; also called a
4.4 M13 has extensive sequence homology to bacterio-
polylinker.
phages f1 and fd, differing in only a few bases. (1)
1
4.5 M13 is used in biotechnology often as a vector into
This guide is under the jurisdiction ofASTM Committee E55 on Manufacture
of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.04
which foreign DNA can be cloned. Commonly used M13
on General Biopharmaceutical Standards.
Current edition approved Nov. 1, 2006. Published November 2006. Originally
2
approved in 1992. Last previous edition approved in 2001 as E1498–01. DOI: The boldface numbers in parentheses refer to a list of references at the end of
10.1520/E1493-06. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1493−06
variants are the M13 mp series. These M13 bacteriophages tant fraction. The phage particles are usually precipitated and
haveaportionofthe E. coli lacoperonwithamultiplecloning concentrated using polyethylene glycol. If the DNAis desired,
site within a truncated lacZ gene. the protein coat is disrupted using phenol.
4.5.1 A portion of the E. coli lac operon containing the 5.2.2 Double-stranded RF DNA is isolated from cells that
3-prime end of the lacI gene, the lac promoter and operator, have been grown ov
...