Source: IMVELA CORP. submitted to
NOVEL BIOPRESERVATIVES TO IMPROVE THE SHELF LIFE OF COTTAGE CHEESE
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
ACTIVE
Funding Source
Reporting Frequency
Annual
Accession No.
1031188
Grant No.
2023-39410-40787
Cumulative Award Amt.
$649,926.00
Proposal No.
2023-03948
Multistate No.
(N/A)
Project Start Date
Sep 1, 2023
Project End Date
Aug 31, 2025
Grant Year
2023
Program Code
[8.5]- Food Science & Nutrition
Project Director
Sheth, R.
Recipient Organization
IMVELA CORP.
141 FLUSHING AVE BLDG 77 STE 907
BROOKLYN,NY 112051338
Performing Department
(N/A)
Non Technical Summary
Dairy products are part of a healthy diet for ~80% of Americans. However they have a short shelf life due to microbial spoilage, making them expensive and restricting access to American citizens. In addition, consumers increasingly demand natural products and do not desire products with artificial chemical preservatives, which are extensively utilized in the dairy industry.Funded by this USDA Phase II SBIR award, we will develop a novel ingredient, a biopreservative, that can extend the shelf life of dairy products, starting with soft cheeses such as cottage cheese. We will employ our unique technology platform to optimize and deliver this ingredient. In particular, this research and development will make use of our extensive biobank of tens of thousands of natural microbes, state of the art measurement technologies targeted towards microbial spoilage, computational/machine learning approaches to select combinations of natural microbes, and advanced bioprocess manufacturing technologies for producing natural ingredients.If successful, this product and the ultimate outcome of the award would decrease food waste and increase food manufacturer distribution and product accessibility, in particular to low income consumers. We project this ingredient could generate ingredient sales for our company of 1-3M/year in the cottage cheese market after launch and up to 43M/year in the broader dairy industry at product line maturity.
Animal Health Component
100%
Research Effort Categories
Basic
(N/A)
Applied
100%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
50240991100100%
Knowledge Area
502 - New and Improved Food Products;

Subject Of Investigation
4099 - Microorganisms, general/other;

Field Of Science
1100 - Bacteriology;
Goals / Objectives
The goal of this award is to develop a biopreservative ingredient that extends the shelf life food products, starting with soft cheeses such as cottage cheese. Dairy products are part of a healthy diet for ~80% of Americans, providing essential protein, calcium, and vitamins. Dairy foods are highly susceptible to microbial spoilage, but chemical preservatives used in dairy foods are increasingly restricted, due to safety concerns. Thus, dairy manufacturers urgently need effective natural alternatives, known as "biopreservatives", which use microbial fermentation to naturally inhibit spoilage organism growth. Whereas chemical preservatives are single molecules with one antimicrobial mechanism of action (MoA), our product combines multiple MoA through rationally selected microbial communities, or "SupercultureTM ingredients" (SCI). Our USDA SBIR PhI research used computational methods and high-throughput screening to identify a novel lead antifungal ingredient. Preliminary Phase I characterization demonstrated that prototype performance significantly exceeds in-market leading biopreservative products and that ingredient production could be scaled up to pilot fermentor volumes. In this Phase II award, we will build on these exciting results by optimizing performance and production, to verify performance at commercial scales, enabling broad commercialization of this high performance biopreservative ingredient, and ultimately reducing spoilage of dairy products.To achieve this goal, we will pursue the following technical objectives (TOs):TO1: Optimize lead ingredient from PhI research and establish economic bioprocess for upstream and downstream manufacturing at commercial scales. Validate one SCI retains similar or better activity with locked-in upstream and downstream processes: production at 10L pilot scales and following spray drying.TO2: Optimize biopreservative performance via focused screening and iteration. Identify at least 3 new lead ingredients which provide 25% improvement in growth inhibition across ≥50% of high priority dairy spoilage organisms tested (ie 15+ strains) compared to current biopreservative solutions.TO3: Test efficacy biopreservative product in realistic dairy matrices. Validate PhI lead in preliminary pilot plant testing at the outset of PhII work, to inform baseline performance in real-world conditions. Internal benchtop application testing in cottage cheese matrix assay to select lead PhII SCI for advancement to 2nd round customer pilot plant trial. Demonstrate PhII lead hit SCI efficacy in full scale commercial pilot in customer plant: target >25% shelf life extension in accelerated shelf life assay. Validate lead SCI in at least one additional soft cheese matrix (>25% shelf life extension in challenge assay compared to current solution)
Project Methods
The key research efforts that will be conducted employ a range of state of the art methods:Bioprocess optimization of fermentation processes, including upstream fermentation and downstream product formulation. This work will utilize state of the art fermentation and bioprocess capacities for natural microorganisms that the company has unique access to. In particular this research will employ design of experiment approaches to reduce experimental burden based on established statistical approaches.High throughput screening and optimization of novel biopreservative ingredients. We will apply our extensive microbial biobank that contains many tens of thousands of unique, food safe, microorganisms to screen for novel ingredients with bioprotectant qualities. In particular, high throughput screening of the biobank against dozens of spoilage organisms and associated statistical analysis will be applied.Combinatorial optimization and assembly of meaningful strain combinations for enhanced ingredient performance. A variety of novel computational and bioinformatic techniques will be applied to the collected datasets to identify lead Superculture ingredients (combinations of natural strains) to advance to further optimization and validation.The key evaluation criteria of the product include:Quantitative measurement of growth inhibition of ingredient against a panel key dairy spoilage organisms (3 new lead ingredients which provide 25% improvement in growth inhibition across ≥50% of high priority dairy spoilage organisms tested)Technoeconomic analysis of the production efficiencies of the identified ingredient (meets internal economic targets for ingredient profitability)Validation of the efficacy of the ingredient in dairy matrices via accelerated and standard shelf life study assays (target >25% shelf life extension in challenge assay compared to current solution)

Progress 09/01/23 to 08/31/24

Outputs
Target Audience:The target audiences for the product (a biopreservative ingredient) developed during this reporting period are: 1) food manufacturers (our target customer) that will incorporate the biopreservative ingredient into finished products to improve product quality and reduce distribution costs through extended shelf life and reduced barrier packaging allowed by our solution and 2) end-consumers who will indirectly benefit from this technology via reduced product costs, increased food accessibility, reduction of artificial chemical consumption and associated potential health benefits. The initial target market for this product is cottage cheese manufacturers, and then subsequently manufacturers of soft cheese and natural cheeses. We have extensively validated the market opportunity through extensive conversations with medium to large manufacturers. Each of these customers has identified an urgent need for clean-label and efficacious biopreservatives that prevent the spoilage of dairy products. They've noted that this need exists due to: 1) increased regulation and scrutiny surrounding the deleterious effects of chemical preservatives 2) increased consumer demand for natural clean label ingredients and 3) the substantial loss of revenue due to food spoilage. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?The project has provided ample opportunities for team members to developapplied expertise across multiple disciplines critical to food biotechnology. In particular, under this award, team members gained additional hands-on experience withpilot-scale fermentation equipment, bioprocess optimization, and food preservation assay development. How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?In the next reporting period, we will follow our technical work plan towards developing this ingredient. In particular, we will focus on fermentation process development (TO1) and further validation of the ingredient in various contexts and scales (TO3). Lead ingredientsidentified under TO2 will be advanced to process development (TO1) and validation (TO3) to further assess their viability. In particular, the work during this reporting period have highlighted the importance of meeting specific targets for ingredient potency and production process cost; creative strategies to meet these constraints will be of special focus in the upcoming reporting period.

Impacts
What was accomplished under these goals? We have made strong progress towards developing a natural biopreservative for dairy products utilizing our unique technology ofrationally selected microbial communities, or "SupercultureTM ingredients" (SCI). Against technical objective (TO) 1,significant progress has been made in developing robust manufacturing processes for our biopreservative ingredient. We have scaled production to pilot level (10L) upstream fermentation, establishing preliminary process parameters for consistent production. In addition, downstream processing optimization for drying was completed while mantaining product activity. This process development represents crucial steps toward establishing viable commercial production of the ingredient. For TO2, our screening identified multiple promising candidate ingredients that show improved activity against dairy spoilage organisms. In particular, a diverse panel of spoilage organisms relevant to dairy applications was onboarded and implemented in the systematic screening pipeline.Additionally, this work has provided valuable insights into optimization opportunities and mechanisms of action. For TO3, we have completed initial testing in relevant dairy matrices, particularly focusing on cottage cheese applications. These real-world application studies have provided critical insights into product performance under actual use conditions and helped identify key parameters for optimization. These accomplishments represent significant progress toward our overall goal of developing natural preservation solutions for the dairy industry.

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