Trade Agreement: WTO-AGP/NAFTA/AIT/Canada FTAs with
Peru/Colombia/Panama
Tendering Procedures: Generally only one firm has been invited
to bid
Attachment: None
Non-Competitive Procurement Strategy: Exclusive Rights
Comprehensive Land Claim Agreement: No
Vendor Name and Address:
Protein BioSolutions inc.
401 Professional Drive
Gaithersburg Maryland
United States
20879
Nature of Requirements:
ADVANCE CONTRACT AWARD NOTICE- 31241-145277/A
The Human Health Therapeutics Portfolio (HHT)-Montreal of the
National Research Council of Canada (NRC) wants to enhance its
capabilities in high-throughput protein purification and protein
purification process optimization in support of industrial
clients and internal projects in the Biologics, Vaccines and
T-BBB programs. Having the capability to perform parallelized,
small and medium-scale purification of antibodies will allow
rapid screening of multiple constructs using a variety of
high-throughput analytical assays. The preparation of sufficient
purified protein for these assays is often the bottle-neck in
assessing new antibody constructs. Having this equipment will
convert these tasks from manual to automated ones, increasing
efficiency, quality control and permitting greater sample
throughput. Once implemented, this instrument will permit
walk-away protein purification, freeing technicians from
time-consuming routine work to pursue more innovative
activities. Parallelized protein purification capabilities will
also accelerate development of new protein purification
processes and fine tuning of protein purification conditions,
ultimately providing more robust processes while saving time and
money for internal and external clients. No equivalent equipment
is available within the NRC HHT-portfolio to perform this kind
of work.
In order to perform automated, parallelized protein
purification, HHT-Montreal wants to purchase the Protein Maker
from Protein BioSolutions. We require the capability of
purifying 40-80 constructs per day from culture volumes ranging
from 20-200 ml. Compared to other liquid handling robots, only
the Protein Maker has the unique capabilities of:
(a) running up to 24 columns at once, performing up to 24
protein purification experiments in parallel
(b) independent control for the 24 columns and their associated
valves and flow paths
(c) use of columns up to 5 ml in bed volume
(d) is able to perform fully automated 2-step protein
purification
The high-throughput processing ability of the Protein Maker is
due to the presence of 24 individual pumps and associated flow
paths, each attached to a 9-port valve, allowing independent
flow control to multiple columns running in parallel. Each valve
contains a syringe, which can be used as a step mixer capable of
blending up to two solutions to control the pH or ionic strength
of binding and elution buffers. The system includes a chilled
deck with 20 plate positions, in order to maintain sensitive
protein samples at the correct temperature. All of the elements
of the system are controlled by specialized software designed
for this instrument.
Sole source justification
No other system matches the Protein Maker in terms of the
numbers and volumes of samples that can be purified in
unattended operation. A key advantage of this instrument is the
ability to use common chromatography columns, such as those
belonging to the Hi-Trap series (GE Healthcare), in 1 ml or 5 ml
bed volume sizes. In particular, the 5ml column size allows
larger sample volumes (20-200 ml) to be processed readily
compared to other liquid handling robots. As these identical
columns can be used on both the Protein Maker and on the
existing Akta platforms, the system provides unique convenience
for method development and transfer from the Protein Maker to
existing FPLC systems for scale-up.
With this instrument, either single-step or two-step
purification can be performed, as samples can be aspirated from
collection plates and dispensed into a subsequent column.
Protein samples are collected into 24-well deep blocks, either
as terminal eluents, or as feed for a subsequent purification
step on the robot. As a liquid handling robot, the Protein
Maker's ability to perform automated, two-step purification is a
unique feature, allowing affinity purification followed by a
second purification step or buffer exchange, in a seamless
manner, without any manual intervention.
This instrument will have a key function to screen
chromatographic resins and purification conditions in order to
establish and optimize protein purification schemes for process
development and scale-up. When coupled with powerful
design-of-experiment (DoE) and quality-by-design (QbD)
strategies, this instrumentation will expedite process
development for external clients. Currently, purification
process development must be performed serially using an Akta
purification platform. This is both time-consuming and
laborious, as each sample must be individually prepared, run on
the specific column under the defined conditions and the results
analyzed to determine the suitability of the method.
With the Protein Maker, many more sample conditions
(pH/conductivity), chromatographic resins, binding, washing and
elution conditions, residence times and flow rates can be
evaluated in parallel in order to more quickly define the
parameters critical to optimizing the purification process.
These better-defined conditions will then be transferred to an
Akta platform, where any fine tuning of the method can then be
performed.
Requirement
We require this specific equipment because no other instrument
has the capacity to process the required number of samples (up
to 40-80 per day), having larger volumes (20-200 ml) and at the
same time, perform automated two-step purification on these
samples.
In summary, the Protein maker is a unique instrument, having the
ability to run up to 24 columns in parallel, with independent
flexibility for each of the 24 flow paths. It allows the
purification of proteins from small volumes up to a litre, using
columns that are compatible with existing FPLC instruments, with
the ability to perform automated two-step protein purification.
All of these features combined make the Protein Maker the only
system that provides the parallelized protein purification
capabilities essential for HHT-Montreal. Protein Biosolutions is
the sole owner, manufacturer and distributor of the Protein
Maker, making it the only source of procurement.
The Drug Analysis Service (DAS) from Health Canada, Regions and
Programs Bureau, requires the purchase of three (3) Fourier
transform infrared (FTIR) detectors which can be coupled with a
gas chromatograph (GC). The analysis of the samples shall be
solid-phase and as a result, the system must allow the
deposition of chromatographed sample in a cryogenic chamber. The
FTIR system must also be able to be coupled, in parallel, with a
mass spectrometer (MS) to give a combined analysis technique
GC-FTIR/MS.
The manufacturer must provide a minimum warranty of one year. In
addition, trained staff must be available for subsequent
technical assistance services.
For all these reasons, we believe that it is the only existing
system capable of meeting all the above criteria.
The purposes of this Advance Contract Award Notice (ACAN) is to
signal the government's intention to award a contract for these
goods to:
Protein BioSolutions Inc.
Suite 130,
401 Professional Drive,
Gaithersburg,
MD, 20879
United States
Before awarding a contract, however, the government would like
to provide other suppliers with the opportunity to demonstrate
that they are capable of satisfying the requirements set out in
this Notice, by submitting a statement of capabilities during
the 15 calendar day posting period.
If other potential suppliers submit a statement of capabilities
during the 15 calendar day posting period that meet the
requirements set out in the ACAN, the government will proceed to
a full tendering process on either the government's electronic
tendering service or through traditional means, in order to
award the contract.
If no other supplier submits, on or before the closing date, a
statement of capabilities meeting the requirements set out in
the ACAN, a contract will be awarded to the pre-selected
supplier.
Quantities: 1 system
Delivery date: Delivery must be made before September 30, 2014
The equipment must be installed and operational to the
satisfaction of the user, in terms of functionality, performance
and timeliness.
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.
