2_JA 2086496 .docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: 3M Filters for Midstream Processing

I. Identification of the agency and contracting activity

II. Description of the project, and supplies or services required to meet the agency’s needs A. Project Background

a. In order to purify any vaccine candidate or therapeutic from cells, the cells and other impurities must be removed prior employing later stage purification techniques. This can be done using a variety of different filters, each playing a significant role in which type of impurity it is removing (such as the cells). The filters described herein allow for single step clarification and for additional purification after the initial downstream step. This technology decreases the filter surface area needed, and provides cleaner material to later stage process steps to potentially increase yield and purity with reduced steps and material costs.

b. There is a large variety in the types of filters needed to filter out certain impurities. We need the two 3M filter types listed in our process development.

B. Description of the supplies/services to be purchased

a. There are two main filter medias listed below; Harvest RC - this filter focuses on combing several different filter types into one capsule to create a single step clarification rather than employing a conventional train technique (or could be used in combination with a larger pore size filter in order to increase the capacity across the filter but still drastically reducing the overall clarification step), Polisher ST – This is a later stage fiter that combines late stage depth filtration and resin column impurity clearance capabilities. The key parameter for evaluation with these filters is their ability to scale, so the order consists of filters varying from the small scale (1 cm2) for proof of concept, to middle stage ( 340 cm2) to analyze process fit and initial scale up, to large scale (1.6 m2) for significant evaluation of scale-up capabilities and for material generation programs.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) ☒ 41 USC 3304(a)(1) and FAR Part 6.302-1: Only one responsible source/Brand Name

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s) 3M Purification Inc.

201 Route 17 North, 4th Floor Rutherford, NJ 07070 877-246-9403

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs.

Each filter manufacturer generates filters with unique characteristics that allow for certain impurities to be cleared wereas other filters do not. These 3M filters provide the filtration capabilities and reduce the number of filters necessary in the process step. The filters employ a resin chemistry that reduces the impurity burden onto later stage purification in the mAb process. The additional filter sizes are crucial to understand the scalability of the new filter technology to evaluate the capability to scale up to the large scale manufacturing. The resin chemistry of these filters is proprietary to 3M Purification Inc, and cannot be replicated. As stated earlier, this filter technology is needed for larger sized manufacturing campaigns, thus the necessity to evaluate the scalability of the process at various filter sizes, feasibility of implementation of the various filter sizes and once scalability is established, to evaluate a cost analysis of implementing such technology in comparison to conventional clarification and purification methods. Therefore, to properly guage the scalability of these new filters, we need different sizes. The second filter media combines several late stage purification techniques and is highly specific to the resin chemistry developed by 3M, thus even small differences in the chemistry can cause drastically different results, necessitating that these filters be aquisitioned from 3M Purification Inc.