Taking your discovery to a clinic-ready product
Stability Indicating Method Development Services
LLS Health understands that the ability to detect chemical, physical, or microbiological property changes in an active pharmaceutical ingredient (API) is crucial during the drug development and commercialization process. Our chemists have a comprehensive grasp of what comprises a robust method and strive to generate meaningful, accurate data to support your target product profile.
For over 20 years, we have been developing a wide range of dosage forms for nearly every route of administration and have seen hundreds of small and large molecules such as peptides, proteins, and oligonucleotides. As a result, we have built up a skill set and a knowledge base that only experience provides.
We can both develop stability indicating methods from inception and can optimize the performance of client-provided methods to ensure compatibility with the formulation being developed.
Fully integrated analytical services
At LLS Health, communication between the analytical services and formulation teams starts early in a project and occurs consistently as a project progresses, allowing us to develop methods that generate early prototype data and facilitate quicker and more streamlined product development.
We deliver methods that are suitable for downstream use as a project progresses towards later development stages. Our goal is to minimize the risk associated with any significant changes in methods which can make data comparison difficult adding cost, time, and complexity to the product development cycle.
Our team ensures the delivery of accurate, high quality analytical data, and sound formulation characterization to support regulatory approval.
Unrivaled expertise in novel and complex dosage forms
Willingness to take on a wide variety of projects has allowed our chemists to build up a robust skill set to work with a range of products:
- Small molecule APIs and biopharmaceuticals
- Functional excipients like preservatives to polymer characterization
- Emulsions and nanosuspensions to elastomeric drug-eluting devices.
Development of validatable methods
Over the last five years, we have executed over 50 GMP validation protocols for complex dosage forms.
Wide range of analytical equipment
Our scientists have access to an array of chromatographic detectors such as PDA (photodiode array), to evaporative light scattering, refractive index, and mass spectrometry for a wide range of molecules.
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 formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing a range of technologies to maximize bioavailability, control release rate, and enhance stability. Our scientists work on projects from early-stage development through scale-up and transition to our clinical and commercial manufacturing teams.
We offer GMP manufacturing for many dosage forms, and our integrated approach creates a smooth transition from pre-clinical activities through clinical validation. We have GMP manufacturing space that is supported by in-house analytical services, bioanalytical services, physicochemical characterization, and ICH-compliant stability programs.
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.