BioStone > MH Bacterin-toxoid Vaccine Collaboration Opportunities > Mannheimia haemolytica MLV Diluent and Combination Vaccine Opportunity

Mannheimia haemolytica MLV Diluent and Combination Vaccine Opportunity

BioStone Animal Health is seeking U.S. and international partners interested in evaluating a Mannheimia haemolytica bacterin-toxoid component for use with modified-live-virus (MLV) bovine respiratory disease (BRD) vaccines.

This program is based on G905.02, a further-manufacturing format derived from BioStone’s Mannheimia haemolytica bacterin-toxoid platform. G905.02 may be evaluated as a biologically active companion component or reconstitution diluent for an MLV BRD vaccine, allowing a partner’s viral vaccine platform to be paired with M. haemolytica coverage.

BioStone welcomes discussions with vaccine manufacturers, MLV platform owners, commercial distributors, and licensing partners interested in combination-product development, distribution, regulatory support, or future commercialization.

This opportunity may be especially relevant for companies that already have an MLV bovine respiratory vaccine platform and are looking to add or strengthen M. haemolytica coverage through a compatible bacterial component.

Additional information about G905.02 is provided below.

PRODUCT INFORMATION

Product type: Mannheimia haemolytica bacterin-toxoid, for further-manufacturing (FFM) format
USDA Product Code: G905.02
Related standalone product code: 7905.02
Target species: Cattle
Potential use: Companion component or reconstitution diluent for MLV bovine respiratory disease vaccines
Biological component: Leukotoxoid and cell-associated antigens from multiple M. haemolytica isolates

COLLABORATION OPPORTUNITY

BioStone is interested in partnering with companies that have:

• Existing MLV bovine respiratory vaccine platforms
• Distribution channels for cattle vaccines
• Interest in adding M. haemolytica coverage to a BRD vaccine program
• Capability to support partner-specific compatibility or non-interference studies
• Interest in U.S. or international commercialization
• Potential collaboration structures may include co-development, licensing, distribution, regulatory support, manufacturing, or further-manufacturing partnerships.

POTENTIAL BENEFITS

• May allow an MLV bovine respiratory vaccine to be paired with an active M. haemolytica bacterin-toxoid component
• Contains leukotoxoid and cell-associated antigens from multiple isolates
• Designed as a ready-to-use further-manufacturing component
• Historical non-interference and combination-product experience available for qualified partner review
• Potential opportunity for companies seeking an MH-only bacterial component without developing one internally

POTENTIAL APPLICATION

G905.02 may be evaluated as a companion component or reconstitution diluent for modified-live-virus bovine respiratory disease vaccines.

When used with an MLV vaccine, G905.02 would be expected to require partner-specific technical and regulatory review, which may include compatibility, safety, potency, efficacy, and non-interference evaluation depending on the partner’s product and intended market.

DEVELOPMENT AND REGULATORY STATUS

G905.02 is currently being presented as a development and collaboration opportunity. Future use with a partner’s MLV vaccine platform would be subject to applicable technical studies, regulatory review, and partner-specific requirements.

BioStone is also evaluating updated manufacturing procedures, endotoxin performance, immune-response data, and reference qualification for the related M. haemolytica bacterin-toxoid platform.

PARTNER DATA REVIEW

Qualified partners may request technical discussions regarding available historical data, product background, development status, and potential study requirements.

Depending on the intended collaboration, BioStone may be able to discuss:

• Historical safety, potency, and efficacy information
• Prior experience with combination-product approaches
• Endotoxin testing and updated manufacturing work
• Immune-response comparison studies
• Potential non-interference study design
• Regulatory and commercialization strategy

IMPORTANT DEVELOPMENT NOTICE

This product is not currently being offered for commercial sale. Future manufacture, distribution, combination use, or commercialization is subject to completion of applicable technical studies, reference qualification, partner-specific compatibility work, and regulatory authorization.

DISCUSS A COLLABORATION

Companies interested in evaluating G905.02 as an MLV companion component or further-manufacturing opportunity are invited to contact BioStone Animal Health.