Acumen BioPharma
Consultancy connecting legal teams and pharmaceutical companies with academic and industry experts to support intellectual property and antitrust litigation, technical due diligence, laboratory testing, process troubleshooting, and regulatory strategy. Services emphasize materials and product characterization, manufacturing process analysis, and expert testimony backed by academic laboratory capabilities and project management.
Industries
Nr. of Employees
small (1-50)
Acumen BioPharma
Oceanport, New Jersey, United States
Products
Manufactured test articles and formulations
Production of direct compression, wet/dry granulated, and hot-melt extruded tablets; capsules; films; suspensions; solutions; emulsions; ointments; ophthalmic and injectable formulations for testing purposes.
Immediate and modified release product variants
Immediate-release, sustained-release, delayed-release (enteric), modified-release, and tamper-resistant product forms produced for evaluation and testing.
Manufactured test articles and formulations
Production of direct compression, wet/dry granulated, and hot-melt extruded tablets; capsules; films; suspensions; solutions; emulsions; ointments; ophthalmic and injectable formulations for testing purposes.
Immediate and modified release product variants
Immediate-release, sustained-release, delayed-release (enteric), modified-release, and tamper-resistant product forms produced for evaluation and testing.
Services
Selection and management of experts, scientific strategy development, expert reports, deposition and trial testimony.
Preparation and testing of ingredients, blends, and unit dosage forms with documentation and chain-of-custody procedures for litigation or QA purposes.
Investigation of product failures, root-cause analysis, design of testing plans, and remediation to achieve and maintain regulatory compliance.
Training on formulation methodologies, PAT, continuous manufacturing, material characterization, and statistical methods for development and manufacturing teams.
Analysis of patent landscapes, infringement risk assessments, support for IND/NDA/ANDA strategy, bioequivalence and REMS planning.
Selection and management of experts, scientific strategy development, expert reports, deposition and trial testimony.
Preparation and testing of ingredients, blends, and unit dosage forms with documentation and chain-of-custody procedures for litigation or QA purposes.
Investigation of product failures, root-cause analysis, design of testing plans, and remediation to achieve and maintain regulatory compliance.
Training on formulation methodologies, PAT, continuous manufacturing, material characterization, and statistical methods for development and manufacturing teams.
Analysis of patent landscapes, infringement risk assessments, support for IND/NDA/ANDA strategy, bioequivalence and REMS planning.
Expertise Areas
- Pharmaceutical product and process design
- Pharmaceutical manufacturing and continuous processing
- Materials and particle characterization
- Analytical method development and testing
Key Technologies
- Scanning Electron Microscopy (SEM) with EDX/EDS
- Transmission Electron Microscopy (TEM)
- Atomic Force Microscopy (AFM)
- Raman spectroscopy and 3D Raman chemical imaging
News & Updates
Company representative served as moderator for a three-part webinar series covering PIV/biosimilars, patent infringement lawsuits, and IP litigation settlement/antitrust litigation.
Principal consultant provided testimony to the House Health Subcommittee on advanced manufacturing and drug shortages.
Announcement of new business unit focused on consulting for continuous pharmaceutical manufacturing processes and implementation.
Contributed opinion article by principal consultant advocating automation in manufacturing as a means to reduce healthcare costs.
Principal consultant and associated research center received a chairman's award recognizing contributions to research and development.
Principal consultant recognized by New Jersey Inventors Hall of Fame with Inventor of the Year Award.
Company representative served as moderator for a three-part webinar series covering PIV/biosimilars, patent infringement lawsuits, and IP litigation settlement/antitrust litigation.
Principal consultant provided testimony to the House Health Subcommittee on advanced manufacturing and drug shortages.
Announcement of new business unit focused on consulting for continuous pharmaceutical manufacturing processes and implementation.
Contributed opinion article by principal consultant advocating automation in manufacturing as a means to reduce healthcare costs.
Principal consultant and associated research center received a chairman's award recognizing contributions to research and development.
Principal consultant recognized by New Jersey Inventors Hall of Fame with Inventor of the Year Award.