The trusted partner for stability analysis solutions
ICH Stability Programs For Drug Product Manufacturing Plans
LLS Health understands that a well-designed, ICH-compliant stability program is central to every drug development plan. We offer comprehensive data and stability packages that complement our development and manufacturing services.
We have ample storage capacity and our equipment and software are fully compliant with applicable regulations providing you with a one-stop-shop for all your stability testing needs.
Custom ICH programs available
LLS Health’s pharmaceutical stability programs are set up with client requirements in mind and operate under ICH guidelines for GMP batches. We design programs that address the required time and temperature considerations for both the chosen active pharmaceutical ingredient (API) and finished dosage form, including custom programs that are developed as needed.
We can provide you with the stability data required for every stage of regulatory submission from Phase I to filing for marketing authorization.
Semi-permeable and impermeable capacity
We offer storage capacity for the incubation of both semi-permeable and impermeable containers.
Under one roof
We believe that offering a whole suite of services, including stability testing, accelerates the overall drug development cycle and minimizes risk.
Electronic lab management system
We have invested in a state-of-the-art software system for the management of stability programs along with the collection and reporting of data, allowing us to provide comprehensive statistical analysis for clients.
- Stability protocol development
- Sample management during a study
- Stability storage at accelerated and long-term ICH conditions
- Photostability (ICH Q1B)
- Stability table preparation and maintenance
- In-house stability testing
Supporting ICH Stability Program Capabilities
LLS Health is a flexible, full-service CDMO, offering formulation development, drug product manufacturing with supporting analytical services and quality oversight as well as professional project management. We can help you every step of the way from concept through commercialization.
Our analytical services range from early stage method development through commercial validation. We are expert in complex sample preparation, and our experienced staff will help you design and execute a phase-appropriate analytical strategy.
Our services include assay, purity, and conformational assessment, as well as release testing. Our knowledge in developing appropriate sample preparation techniques allows for robust characterization of both components of the formulation, in situ and ex situ.
Our purpose-built commercial manufacturing facility is ideally suited to sterile and complex drug products, including those with small batch sizes and sterility requirements. We have GMP manufacturing space that features a well-equipped processing room as well as Grade A filling and lyophilization suites.