Culture Collections

How to Submit Patent Deposits


Complete the following forms (at the bottom of this page)

1. Patent Deposit Submission Form

2. Biohazard Risk Assessment Form

The Biohazard Risk Assessment, including the Genetically Modified Organism (GMO) status, is a legal requirement in accordance with the UK Health and Safety Laws. When completing the risk assessment ensure the possible pathogenicity of the microorganism to humans is stated.

Submit completed forms to the Culture Collections

The Public Health England Genetic Modification Safety Committee (GMSC) will review the Biohazard Risk Assessment. Any deposit classified as GMO category 2 or higher category cannot be accepted unless approved by both the Health and Safety Executive (HSE) and GMSC. Upon approval of a patent deposit submission the Culture Collections will notify the depositor to arrange receipt of the patent deposit. Similarly, if a patent submission is not approved ECACC will contact the depositor to explain the reason why.

Await notification from the Culture Collections prior to sending the patent deposit

The Culture Collections will contact you and provide you with a reference number if your patent deposit is approved for receipt. Ensure you have read the Guidelines for Acceptance of Patent Deposits (below) and you understand that a patent deposit cannot be accepted unless twelve (12) identical ampoules are received.

Use correct packaging

Packages should be clearly labelled with the storage temperature, sender’s contact information and the reference number. Packaging and transportation must be used in accordance with UN 602 regulations. Approved UN 602 packaging may be obtained from several suppliers, the details of which are available from any Royal Mail Sales Centre. If you use a courier service to deliver your samples, please contact the company involved for advice on their own approved packaging. 

 

Guidelines for Acceptance of Patent Deposits

All deposits must be preceded by a 

1. Patent Deposit Submission Form

2. Biohazard Risk Assessment Form 

A consignment may be rejected if:

(i) the package is damaged in any way that could compromise containment
(ii) appropriate shipping temperatures have not been maintained
(iii) ampoules are not completely sealed
(iv) ampoules are not clearly labelled
(v) twelve identical ampoules prepared from a single batch have not been provided

A patent deposit cannot be accepted unless 12 identical ampoules are received.

The twelve ampoules must be prepared from a single batch so that QC procedures carried out on one ampoule represent all ampoules. If this has not been followed the Culture Collections will request a new deposit or, alternatively, the Culture Collections may be able to re-bank the patent deposit. If a deposit is unacceptable or fails the QC tests the ampoules will be returned to the depositor for destruction. The Culture Collections will not destroy patent deposits. If a new deposit is required this will result in a new accession number.

 

 

QC Testing of Patent Deposits

Quality Control tests are performed on one of the 12 deposited ampoules. Depending on the type of patent deposit the following QC tests are performed: 

 

Type of Patent Deposit

QC Test Performed

Human cell Line 

Animal cell line

Hybridoma cell line

  • cell count
  • viability check
Virus
  • viability of virus patent checked according to instructions provided by the depositor on the patent deposit form
Bacteria
  • viability check
  • purity check
Plasmid DNA
  • purity and condition check – DNA is assessed by agarose gel electrophoresis
Naked DNA
  • purity and condition check - DNA is assessed by agarose gel electrophoresis

 Upon successful completion of the QC testing the patent depositor is issued with a Certificate of Acceptance confirming the date the deposit was received. The depositor will be informed if the patent fails the QC tests.

 

Remember: A patent deposit cannot be accepted unless 12 identical ampoules prepared from a single batch are supplied.

The depositor is entirely responsible for the costs of transportation of deposits to the Culture Collections.

 

Patent Deposit Submission Forms

Patent Deposit Submission - Cell Lines and Hybridomas

Patent Deposit Submission - Bacteria & Fungi

Patent Deposit Submission - Virus

Patent Deposit Submission - Recombinant DNA

 

Biohazard Risk Assessment Form - Cell Lines

Biohazard Risk Assessment Form - Viruses

Biohazard Risk Assessment Form - Bacteria

 

 

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