Xcelerate Development Services:
Accelerating and de-risking the product development process
Aptar CSP Technologies is a true innovation partner, offering a complete suite of services to assist our customers from concept ideation through commercialization. Our experienced teams can support you throughout any stage of the development process and apply their depth of expertise to assure your projects have the best possible outcomes.
Our advanced technology allows us to create custom solutions that will meet the most stringent customer specifications and our comprehensive approach allows customers to get the most effective system design on the market.
Xcelerate Development Services, which was named a 2019 All-Star Innovator by Pharma Manufacturing magazine, expedites time-to-market with a “right-the-first time” approach to solution design and active packaging development. The suite of services includes:
Feasibility Assessment & Compatibility Studies
Our Feasibility Assessment & Compatibility Studies services are the foundation of assuring expedited, high-quality development of the ideal solution for your needs. Aptar CSP’s engineers work closely with your development team to analyze your technical requirements early in development to assure our proposed solutions deliver optimal protection. This detailed analysis enables us to establish the precise microclimate required to meet stability and shelf life needs, evaluate how temperature and other environmental factors can impact performance, and understand how potential release of gasses from the product affect compatibility.
For oral solid dose projects, we leverage FreeThink Technologies’ ASAPprime® software to model and test optimized active packaging solutions without the need for expensive and time-consuming line trials. This reduces the entire solution design, testing, and implementation process. Drug characterization, evaluation of physical and functional drug product degradation, and feasibility samples are key components of this service.
Solution Design & Development
Based on the feasibility assessment and compatibility study results, Aptar CSP Technologies develops preliminary configurations that are customized to meet the unique needs of each drug, drug delivery system, medical device, or diagnostic test that needs protection. Proven solutions currently on the market range from primary active packaging for oral solid dose drugs and probiotics, to Activ-Film™ technology integrated into packaging materials, medical devices, diagnostic strips, or dermal delivery methods, to custom active molded polymer components that replace a current polymer part in a drug delivery device. The possibilities are endless.
Regardless of the challenge, we work together with our customers to develop a custom solution with a precise formulation to meet their specific needs, resulting in the most effective component and system design possible. This service includes design and renderings of the proposed solution, prototyping the designs for stability testing, robustness studies, regulatory compliance statements and more.
Extractables & Finished Product Characterization Testing
Evaluating the potential for various chemicals to migrate from container closure systems, drug delivery devices, or manufacturing components into pharmaceuticals is a critical step in the drug development process. Extractables & leachables testing is required by regulatory agencies prior to drug approval in order to identify any risks to the product’s integrity and safety. Our Extractables & Finished Product Characterization Testing services confirm that integration of our technology into our customers’ solutions will provide the optimal protection needed without jeopardizing the product’s efficacy or safety. We conduct thorough testing to assure that the compounds we use in our active polymer solutions will not migrate from the contact surface under the most aggressive conditions, such as elevated temperature, extended contact time, or aggressive solvent systems.
Stability Studies & Validation/Specification Development
Once a design is chosen, Aptar CSP supports sample preparation of the packaged product for stability and clinical studies. This includes GMP batches/product, assembly design consulting, technology transfer to the company conducting filling operations (CMO) for the stability assessment if needed, and temperature cycling using finished products. We conduct routine testing and analysis in every aspect of the development and manufacturing process to ensure our customized material science solutions meet or exceed your critical requirements for product stability. Our commitment to scientific innovation and quality processes ensures our solutions deliver the highest levels of stability performance under real world conditions. Robustness studies, stress testing, ISTA shipping studies and drop characterizations are important elements of this service.
Design/Tooling Validation & Human Factors/User Studies
Human factors and user studies are a key component to assuring the safety of any device or drug delivery system. Aptar CSP offers support and consulting services, including training on product handling and on-site support for human factor and user studies. We will provide a formative report that can be included in the drug or device’s FDA submission. From a design/tooling validation standpoint, we work with our customers to create specifications, develop instructions for use, and study capacity loss in the production environment to assure there are no surprises at time of commercialization.
Commercial & Regulatory Submission Readiness
Aptar CSP offers global regulatory compliance and support throughout the development process, providing our customers in the pharmaceutical, medical device, diagnostics, and food safety industries with strict adherence to regulatory guidelines. During the pre-submission process, we partner with our customers to navigate through the regulatory landscape to help expedite preparation for FDA submission. Key services include DMF access authorization letters, pre-inspection preparation, and compliance statements. We can also serve as your consulting partner, collaborating with regulators and facilitating discussions with the FDA pre-NDA submission.
In addition to this support, you can rest easy knowing that Aptar CSP Technologies’ manufacturing plants meet requirements set forth by the U.S. FDA and are compliant with the FDA’s Current Good Manufacturing Practice (cGMP) regulations. Our proprietary 3-Phase Activ-Polymer™ formulations are included in the US Drug Master File (DMF #14789). Aptar CSP’s facilities are ISO-9001, ISO-13485 and ISO-14001 certified.
Market Launch & Post Commercialization Support
At Aptar CSP Technologies, we know your journey doesn’t end at market launch. That’s why we offer support services that take you to launch date and go beyond. Aptar CSP is your partner for pre-inspection preparation including participating in mock audits or providing on-site support during actual audits. We provide support during FDA inspection, and documentation and record review during on-site audits to help assure your success. When desired, Aptar CSP can also partner with you for risk evaluation and mitigation strategy, investigation management, change control management (internal maintenance), record controls, design history file and management, and data trending for Critical Quality Attributes.