Purificateur de Proteines

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.