Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products and can include combinations of the following types: drug-device, biologic-device, drug-biologic and drug-device-biologic. They can be physically or chemically combined, packaged together as a kit, or be separate, cross-labeled products. Examples of combination products include: prefilled syringes, antimicrobial-coated catheters, co-packaged products that are required to be delivered sequentially for therapeutic effect, biologic or synthetic surgical patches that are pre-packaged into delivery devices, and drug-eluting stents.
Combination product manufacturers face numerous challenges getting new products to market, including developing appropriate preclinical and clinical plans to evaluate safety and effectiveness, preparing compelling regulatory submissions, and developing comprehensive post-marketing strategies. From a business standpoint, it is important that clients understand the market and reimbursement strategies for their products under development. Given their multidisciplinary nature, combination products become more challenging with regard to regulatory compliance, product development, intellectual property, and failure analysis.
Exponent provides the highest quality engineering, regulatory, safety assessment, epidemiological, and health economics services to assist our clients with matters related to combination products. We specialize in providing rapid, focused, market-sensitive solutions to complex topics.
Combination Drug Product Development Assistance
We assist with combination drug product development and CMC issues during pre-clinical, clinical, and post-marketing development phases, including primary container selection and development, container closure development and testing, drug delivery system (DDS) selection and development, toxicology, pharmacology, formulation development, and improvement; compatibility of the DDS with the targeted formulations, primary container and DDS manufacturing and process scale-up; development of DDS sections of combination product clinical trials, instrument development/validation and data analysis for DDS systems during clinical trials, DDS therapy modeling, stability of drug delivery combination products, product performance optimization and improvement, and product safety and reliability.
Device-related infections are a serious complication associated with many types of implantable devices, including catheters and stents. Antimicrobial applications may be an effective approach for inhibiting microbial adhesion to and colonization of devices. Exponent staff have extensive experience in the development and evaluation of antimicrobial-device combinations, including coatings and bio-responsive polymers.
Regulatory Agency Assistance
Exponent has successful experience with the regulatory agency interactions and communication with healthcare professionals for new single entity, as well as fixed-dose combination product submissions.
Exponent Combination Product Service Areas
Our multidisciplinary team is experienced in many service areas that can assist you throughout the development and commercialization phases of combination products:
- Biocompatibility & Thromboresistance
- Cardiovascular, Neurovascular, Peripheral Endovascular, Pulmonary, Tracheal-bronchial, Biliary & Renal (CVNP) Implantable Devices
- Clinical Epidemiology
- CMC Drug Substance and Product Development
- Contamination Control in Medical Devices, Pharmaceutical & Biotechnology Manufacturing Operations
- Disposable device development for vial access devices, spikes, reconstitution systems, infusion sets and components such as rigid/flexible container access sub-assemblies / tubing / air elimination filters / check valves / luer activated devices (LADs) / slide clamps / connectors and catheter systems and subcutaneous delivery sets
- Dose-response Modeling
- Drug-biomaterial Compatibility Assessments
- Finite Element Analysis for Medical Devices & Biomaterials
- Health Economics and Outcomes Research
- Intellectual Property
- Manufacturing Process Control / Quality Assurance
- Medical & Economic Assessment of Medical Devices
- Medical Device Regulatory Compliance & Recall
- Medical Devices, Implants & Surgical Tools
- Medical Technology Acquisition
- Medical Implant Wear, Fatigue & Corrosion Testing
- MRI Compatibility Testing
- Pharmaceutics and Drug Delivery Systems
- Pharmacokinetic & Physiologically Based Pharmacokinetic (PBPK) Analysis
- Philadelphia Medical Device Laboratories
- Development and Third Party Evaluation of ambulatory infusion pump, disposable elastomeric pumps, path pumps, implantable pumps and self-contained delivery devices
- Preclinical Development
- Primary containers (pre-filled syringes and cartridges, flexible containers, vials, ampoules and Aluminum bottles) and closure development and assessment
- Probabilistic Risk Assessment
- Regulatory and Quality Assurance Support
- Risk Communication
- Tissue Science and Engineering.
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