PWS_Prototype phage hygiene spray bottles final (10-23-26).pdf

PWS_Prototype phage hygiene spray bottles final (10-23-26)

PERFORMANCE WORK STATEMENT (PWS)

Project Title: Procurement of prototype phage hygiene spray bottles

A. Introduction / Background

Project seeks to design and test spray formulation suitable for phage hygiene products that maintain activity under extreme thermal conditions. Once a spray formula is identified and passes all necessary testing, prototype spray devices will be assembled for testing. Soldier Center has identified a phage cocktail (PhageShield, supplied by Intralytix) having suitable activity and stability in lab-based solutions and is testing potential formulation components used for topical skin applications for maintenance of titer and stability. Various components include phage storage buffer solutions, preservatives, potentiators, emollients, humectants and other additives utilized cosmetic products.

This request for sole source justification is for a contract with Desert in Bloom (DiB) to conduct the development, safety testing, and production of custom prototype bacteriophage hygiene sprays designed for intimate skin applications to target UTI-causing E. coli.

Market research confirms that DiB is the only source capable of meeting these strict technical and safety requirements without causing extreme project delays and duplicated costs. Standard topical cosmetic manufacturers lack the biological expertise to handle live phages, while traditional phage laboratories do not possess the cosmetic-adjacent formulation infrastructure for sensitive skin areas. DiB has previous experience working with phage for cosmetic products, including making prototypes and formulation development for thermal stability needed for product storage at elevated temperatures that meet cosmetic regulatory requirements.

"In accordance with FAR 37.104(a), this requirement does not constitute a personal services contract as it does not create an employer-employee relationship. All tasks will be executed independently by the contractor, and the Government will not exercise direct supervision or control over contractor personnel.”

B. Objectives

DEVCOM Soldier Center (SC) is requesting Desert in Bloom (DiB) to design, develop and test a phage friendly formulation for prototype cosmetic phage hygiene sprays. Phage formulation properties will include maintenance of thermal stability and possess suitable properties for manufacture of prototype cosmetic products (Table 1). Components must not inhibit or otherwise reduce phage titer during storage, including at elevated temperature (45oC) for 4 weeks.

Table 1. Formulation component information.

Inclusion Criteria Exclusion Criteria

Solution between pH 7-7.5 Any buffer below pH 7

Phage compatible preservatives effective at pH 7-8

Preservatives that reduce phage titer/ activity or compounds requiring low pH (<7) to be effective

Divalent cations: Mg 2+

, and/or Ca 2+

Components or additives that reduce phage titer/activity, Phage titer: >1E8 PFU/ml Titer below 1E8 PFU/ml

Polyvinyl alcohol or alternative thermostabilizers (up to 1%) Any component below pH 7

Table 1. Formulation component information.

SC tasks include:

1) Data will be provided via email to DiB regarding SC formulation components and development as the 1st iteration. Data includes formulation identified by SC that: 1) maintains PhageShield cocktail thermal stability/titer, and 2) preservative challenge test demonstrating preservative functionality in SC formulation.

2) Supplying PhageShield cocktail to DiB at >1E8 PFU/ml concentration, with purity meeting the guidelines for cosmetic hygiene products (removing host cell proteins, bacterial endotoxins and absence of residual host toxins and bacteria to avoid triggering skin irritation).

3) Testing formulation iterations and prototypes from DiB for PhageShield cocktail thermal stability/titer.

4) Providing data via email to DiB on iteration effects on PhageShield cocktail thermal stability/titer.

DiB tasks include:

1. Formula development & optimization

1. The contractor shall independently formulate and deliver three (3) formulation iterations incorporating PhageShield cocktail supplied by Intralytix. Following the delivery of each iteration prototype, the Government will provide data of the formulation effect on PhageShield thermal stability/titer and determination of formulation suitability for potential inclusion into prototype sprays. The contractor shall independently analyze this data to determine and execute subsequent formulation adjustments, leveraging its proprietary prototyping expertise to deliver the next physical iteration.

o Iteration 1 will be formulated by DiB using previous generated data at SC (Tables 1 and

2) and will be sent to SC for evaluations/ assessment. SC will return the results of

PhageShield cocktail thermal stability/titer thermal stability data to DiB.

o Iteration 2 will be developed after receiving the assessment results for iteration 1 by DiB leveraging their phage prototyping expertise. DiB will assess the results to inform adjustments/changes to the spray formulation composition to improve/ maintain

PhageShield cocktail thermal stability/titer at 45oC storage. This may involve adjusting formulation concentrations or substituting alternatives components within the limitations described in Tables 1 and 2. This iteration will be sent to SC for evaluations/ assessment of PhageShield cocktail thermal stability/titer.

o Iteration 3 will be developed by DiB after receiving the results of the iteration 2 evaluations. DiB will assess the results to inform adjustments/changes to the spray formulation composition to maintain/ improve PhageShield cocktail thermal stability/titer at 45oC storage. This may involve adjusting formulation concentrations or substituting alternatives components within the limitations described in Tables 1 and 2. This iteration will be sent to SC for evaluation/ of stability properties as the final formulation.

2. Formulation Testing: Formulation components will be combined and assessed for: 1) thermal stability

(3-cycle freeze/thaw testing and accelerated heat stability testing); 2) preservative challenge test; and

3) Human Repeated Insult Path Test (HRIPT).

Moisturizers (humectants/emollients) Components that reduce phage titer/activity

▪ After DiB testing, formulas will be returned on ice to Soldier Center for phage titer determination (described in section C. Deliverables).

Table 2. Components for iteration 1 identified by SC as starting point for development and optimization.

Examples of alternatives tested by SC are included for potential consideration for formulation optimization and the concentrations typically used in cosmetic topical application products (not an all-inclusive list).

Component type Components SC tested Concentration Alternative examples

(concentration)

Phage buffer

NaCl 100 mM TBD by DiB

Mg 2+

: MgSO4, 8 mM MgCl2 (20 mM to 100 mM)

Ca 2+

: CaCl2 (1 to 10 mM)

Tris-HCl, pH 7 to 7.5 <2% Sodium phosphate buffer

(10 mM to 50 mM)

Stabilizers Polyvinyl alcohol (96, 10 kDa) 0.1% to 1% xanthan gum, disodium cocoamphodiacetate (DSC)

Preservatives Phenoxyethanol 0.6% to 1% Phage friendly preservatives function at pH 7-7.5 (defer to DiB expertise) Phenylethyl alcohol up to 1%

Preservative enhancer Ethylhexylglycerin 0.3% to 1%

Other potentiators (defer to

DiB expertise)

Moisturizer

(humectant/emollient) Monopropylene glycol 0.5% to 5%

Caprylyl Glycol

(0.5% to 2%)

1,2 Hexanediol

(0.5% to 3%)

2. Prototype production: Once formulation is finalized, prototype spray bottles will be made containing

PhageShield cocktail in optimized formulation, and formulation only (no phage).

• Optimized formulation that maintains thermal stability and suitable for prototype cosmetic sprays.

Components include PhageShield cocktail (concentration >1E8 PFU/ml), phage buffer (pH 7 to

7.5), stabilizer(s), preservative(s)/enhancer, moisturizer(s) (humectants/emollients).

• Number of units: 50 bottles with PhageShield cocktail in optimized formulation, 50 bottles containing formulation only. Prototypes delivered to SC overnight on ice or ice packs (described in section C).

• Spray bottle volume: 15 ml (0.5 oz), with 14 ml solution.

• Spray bottles must have fine mist pump delivery (70 – 150 ul).

• Spray bottles must have 360-degree delivery (including when sprayed upside down)

• Spray bottle material: opaque plastic (HDPE).

• Spray bottle caps and neck to be sealed with heat-shrunk plastic.

• Spray bottles to be labeled numerically 1 to 50 (for formulation only, no phage) and 51 to 100

(for PhageShield cocktail in optimized formulation).

• Package spray bottles numbered 1-50 separately from bottles numbered 51-100. Use cardboard boxes with dividers to keep the bottles protected and separated.

• DiB will purchase spray bottles.

Regulatory process: Establish that the product meets Modernization of Cosmetic Regulation Act

Compliance (MoCRA) specifications:

• Preservative Challenge Testing: ensures the product remains free from bacterial, yeast and mold contamination during storage.

• Ingredients Toxicity Study: A safety assessment to determine the toxicity of individual ingredients in the formula based on published studies and safety assessments in cosmetic products.

The prototypes from this procurement will be evaluated in a user acceptability study by female

Warfighters.

Excluded Services: Phage titer stability determination

C. Government Furnished Material (GFM)

The Government shall provide the Contractor with the specific materials, data, and property:

• Material: 20 ml of PhageShield cocktail at concentration of 1E10 PFU/ml at cosmetic grade purity.

• Data: 1) Results for phage thermal stability testing by SC, including components and concentrations to inform iteration 1 by DiB; 2) phage storage study results determining stability and phage titer for iterations 1, 2 and 3 sent to SC by DiB to inform formulation for prototype sprays.

Government Furnished Material (GFM) is provided strictly on an "as-needed" basis to support the execution of tasks outlined in this Statement of Work. The Contractor shall use GFM solely for the performance of this contract.

D. Deliverables

Three (3) formula iterations, including a data sheet of ingredients and concentrations of each component.

50 ml of each will be shipped to SC on ice or ice packs for phage titer and thermal stability determination.

Formulation iterations to be shipped to SC overnight on ice or ice packs (2-8oC) by FEDEX with tracking number. Samples to be shipped on a Monday or Tuesday to ensure arrival at Soldier Center no later than

1430 and by Thursday. Packages (up to 70 lbs.) delivered to SC mail room will be picked up by SC personnel and stored refrigerated (2-8oC).

I. Purchase of 50 bottles containing phage in optimized formulation. Components include

PhageShield cocktail (concentration >1E8 PFU/ml), phage buffer (pH 7 to 7.5), stabilizer(s), preservative(s)/enhancer, moisturizer(s) (humectants/emollients).

a. Prototypes to be shipped to SC overnight on ice or ice packs (2-8oC) by FEDEX with tracking number. Samples need to arrive at Soldier Center no later than 1430 and by

Thursday. Package (up to 70 lbs. delivered to SC mail room will be picked up by SC personnel and stored refrigerated (2-8oC).

II. Purchase of 50 bottles containing optimized formulation only, no phage. Components include, phage buffer (pH 7 to 7.5), stabilizer(s), preservative(s)/enhancer, moisturizer(s)

(humectants/emollients).

a. Prototypes to be shipped to SC overnight on ice or ice packs (2-8oC) by FEDEX with tracking number. Samples need to arrive at Soldier Center no later than 1430 and by

Thursday. Package (up to 70 lbs. delivered to SC mail room will be picked up by SC personnel and stored refrigerated (2-8oC).

Milestone

Description & Deliverables Completion

Window

Payment

Percentage

Formulation Iteration 1 Delivery & Preliminary

Evaluation

• Shipment of 50 mL Iteration 1 formulation on ice or ice packs (2–8°C) with bottle in an insulated cooler within a cardboard box.

Delivery documentation and component list/concentrations per Table 2.

• Completion of 3-cycle freeze/thaw and accelerated thermal stability data.

• Completion of Preservative Challenge

Testing and Ingredients Toxicity Study.

Weeks 4–8

25%

Formulation Optimization & Regulatory Safety

Testing

• Delivery of subsequent formulations

(Iterations 2 & 3, 50 mL on ice or ice packs (2–8°C) with bottle in an insulated cooler within a cardboard box.).

• Completion of 3-cycle freeze/thaw and accelerated thermal stability data.

• Completion of Preservative Challenge

Testing and Ingredients Toxicity Study.

• Human Repeated Insult Patch Test (HRIPT) results and final formula selection.

Weeks 16–28

40%

III. Spray bottle having fine mist pump delivery.

IV. Spray bottle material: opaque plastic bottles.

E. Delivery

Up to 40 weeks after contract award, based on task time frame:

• Three (3) iterations of formulation design/optimization = 4-6 weeks

• Stability testing for each iteration = 2-4 weeks

• Once formulation is final, testing and prototype spray production = 8 weeks

F. Acceptance criteria

a) Formulations: Turnaround time for inspection and acceptance will be up to 1 week. Acceptance criteria will be:

1. Package undamaged.

2. Bottle packaging intact.

3. Bottles not damaged or leaking.

4. Bottle contents at the appropriate volume (50 ml).

5. Samples are on ice or ice packs (2-8oC). Turnaround time for SC to supply data on phage titer stability from 2-6 weeks after iteration receipt.

b) Prototypes: Turnaround time for inspection and acceptance will be up to 1 week. Acceptance criteria will be:

1. Shipping package undamaged.

2. Bottle packaging intact.

3. Opaque bottles not damaged or leaking.

4. Bottle contents at the appropriate volume (14 ml).

5. Samples are on ice or ice packs (2-8oC). Turnaround time for SC to supply data on phage titer stability from 2-6 weeks after iteration receipt.

G. Period of performance

Milestone 3

Final Prototype Spray Bottle Delivery &

Acceptance

• Delivery of 100 prototype bottles (50 bottles with PhageShield cocktail in optimized formulation, 50 bottles formulation only) meeting specifications (HDPE, fine mist, 360° actuator, heat-shrunk seal).

• Shipment verification on ice or ice packs (2–

8°C) with bottle in an insulated cooler within a cardboard box within delivery time windows.

Weeks 36–40

35%

10 months after contract award.

H: Place of performance

Desert in Bloom Cosmetic Labs LLC, Santa Fe, NM.

I: IP/Data Rights

SC will retain IP and data rights from stability patent application (18/081,461). No additional IP is anticipated.

J: Invoicing

This contract is a Firm-Fixed-Price (FFP) completion contract. Desert in Bloom (DiB) shall submit invoices upon the formal inspection and written acceptance by DEVCOM Soldier Center (SC) of designated milestones outlined in deliverables section above. Invoices shall not be submitted in advance of deliverable acceptance. Each invoice must reference the contract number, project title (Procurement of prototype phage hygiene spray bottles), specific milestone(s) completed, and associated acceptance documentation.