Development of Plant-produced Humanized Antibodies

Trade Agreement: Agreement on Internal Trade (AIT)
Tendering Procedures: The bidder must supply Canadian goods
and/or services
Attachment: None
Non-Competitive Procurement Strategy: Government Objectives
Representing Best Interests/Value to Govt
Comprehensive Land Claim Agreement: No
Vendor Name and Address: 
University of Guelph
University of Guelph
Office of Research
437 University Centre
Guelph Ontario
Canada
N1G2W1
Nature of Requirements: 
Title:  Development of Plant-produced Humanized Antibodies

1. Advance Contract Award Notice
An ACAN is a public notice indicating to the supplier community
that a department or agency intends to award a contract for
goods, services or construction to a pre-identified supplier,
thereby allowing other suppliers to signal their interest in
bidding, by submitting a statement of capabilities. If no
supplier submits a statement of capabilities that meets the
requirements set out in the ACAN, on or before the closing date
stated in the ACAN, the contracting officer may then proceed
with the award to the pre-identified supplier.

2. Definition of Requirement
Defence Research and Development Canada (DRDC) - Suffield,
Medicine Hat, Alberta has a requirement for a Contractor to
produce an anti-ricin antibody using a tobacco plant-expression
system with humanized glycosylation patterns.

Background information:
Antibodies can be effective therapeutics for an exposure to
biological warfare agents.  DRDC has developed a humanized
anti-ricin antibody that shows efficacy at lower doses than
published anti-ricin antibody therapeutics and also has an
expanded treatment window.  Advancement of antibodies for
clinical use requires the development of a production process
that is amenable to GMP manufacturing.  DRDC, in consultation
with Canadian Forces Health Services, has identified a plant
expression system as a viable way forward for production of
DRDC's anti-ricin antibody. Plant expression systems are fast,
efficient, highly versatile (for new product development),
easily scalable, and have significantly reduced manufacturing
costs.  Additional modifications can be made to the plant
expressed systems to more closely mimic human protein expression
to maintain effective pharmacokinetic profiles.

Due to the nature of this work it is expected that there may be
follow-on contracts.

3. Criteria for assessment of the Statement of Capabilities
Any interested supplier must demonstrate by way of a statement
of capabilities that it meets the following requirements:

a) a PhD in a natural science. 
b) experience producing recombinant proteins, antibodies and
antibody fragments in tobacco plants.
c) experience producing proteins with human glycosylation
patterns in tobacco plants
d)experience producing recombinant proteins, antibodies and
antibody fragments in tobacco plants that will be used as
Chemical or Biological Warfare Threat Medical Countermeasures

4. Applicability of Trade Agreements
This procurement is subject to the following trade agreements:
Agreement on Internal Trade (AIT).

5.  Justification for Pre-Identified Supplier
The proposed sole source contract focuses on the investigation
linked to previous procurements and strategy for pursuing
protein production in tobacco, that involved human glycosylation
patterns and development of small molecule specific antibodies
in a collaboration of DRDC Suffield and University of Guelph.
The previous procurements were tendered by ACAN (W7702-135554)
and competitively (W7702-115040) and awarded to Dr. J.
Christopher Hall of University of Guelph.

For the open-competitive contract, Dr J. Christopher Hall of
University of Guelph (W7702-115040) was the only bidder due to
the extensive experience in both of the required fields (protein
production in tobacco, and development of small molecule
specific antibodies) This contractor also has rights to a line
of genetically engineered tobacco for the production of
therapeutic proteins for improved human tolerability over other
plant expression systems available which is critical to meeting
the objectives of the proposed contract. The current procurement
will leverage the previous R&D work developed in the previous
contracts. 

6.  Government Contracts Regulations Exception
The following exception to the Government Contracts Regulations
is invoked for this procurement under subsection 6(d) - "only
one person is capable of performing the work".

7  Exclusions and/or Limited Tendering Reasons
The following exclusions and/or limited tendering reasons are
invoked under the section of the trade agreement specified:

Agreement on Internal Trade (AIT) - Limited Tendering under
Article 506, #12 b and h.

8.  Ownership of Intellectual Property
Defence Research and Development Canada (DRDC) has determined
that any intellectual property arising from this contract will
vest in Canada. DRDC is exempted from the Treasury Board "Policy
on Title to Intellectual Property Arising Under Crown
Procurement Contracts" approved 1 June 2000.

9.  The Period of the Proposed Contract
The proposed contract is from one (1) year from date of contract
award.  

10.  The Estimated Cost of the Proposed Contract
The estimated value of the contract, is $295,000.00 (GST
included).

11.  Name and Address of the Pre-Identified Supplier:
University of Guelph
School of Environmental Science
Guelph ON 
Attention:  Dr J. Christopher Hall

12.  Suppliers' Right to Submit a Statement of Capabilities
Suppliers who consider themselves fully qualified and available
to provide the goods, services or construction services
described in the ACAN, may submit a statement of capabilities in
writing to the contact person identified in this notice on or
before the closing date of this notice. The statement of
capabilities must clearly demonstrate how the supplier meets the
advertised requirement.

13.  The Closing Date and Time for Accepting Statements of
Capabilities
2:00 MST January 6, 2014

14.  Inquiries and Submission of Statement of Capabilities
Inquiries and statements of capabilities are to be directed to:

Mony Lee, Supply Specialist
Public Works and Government Services Canada
Telus Plaza North
5th Floor 10025 Jasper Avenue
Edmonton, AB   T1J 1S5

Telephone:780-497-3535
Facsimile: 780-497-3510
E-mail: mony.lee@pwgsc-tpsgc.gc.ca

Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate
with one firm only as identified above. Should you have any
questions concerning this requirement, contact the contracting
officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and
agencies to post a notice, for no less than fifteen (15)
calendar days, indicating to the supplier community that it
intends to award a good, service or construction contract to a
pre-identified contractor. If no other supplier submits, on or
before the closing date, a Statement of Capabilities that meets
the requirements set out in the ACAN, the contracting authority
may then proceed with the award.  However, should a Statement of
Capabilities be found to meet the requirements set out in the
ACAN, then the contracting authority will proceed to a full
tendering process.

Suppliers who consider themselves fully qualified and available
to provide the services/goods described herein, may submit a
statement of capabilities in writing to the contact person
identified in this Notice on or before the closing date of this
Notice. The statement of capabilities must clearly demonstrate
how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the
closing date of the ACAN must appear on the outside of the
envelope in block letters or, in the case of a facsimile
transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any
procurement.

Documents may be submitted in either official language of Canada.