Taking your discovery to a clinic-ready product
Analytical Method Development and Validation
A core strength of LLS Health is our ability to develop and validate methods to support even the most complex dosage forms. We routinely compile method validation packages that include complicated multi-step sample preparations, considering the recovery of active pharmaceutical ingredients (APIs), impurities, and/or the dissolution performance of your product.
Over the decades we have supported the development of hundreds of small and large molecules such as peptides, proteins and oligonucleotides. We work with a wide range of dosage forms in virtually every route of administration and indication. Our physical and chemical characterization labs are well-equipped and well-staffed to support these efforts.
Fully integrated project teams
Our analytical scientists are fully integrated into our project teams from the beginning allowing full visibility into our clients end goals and target product profiles. From this vantage point, the analytical team works with our formulation team to develop robust methods in a phase-appropriate manner as the project progresses.
Unrivaled expertise in complex dosage forms
Over the last five years we have executed over 50 GMP validation protocols for 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 to biopharmaceuticals
- Functional excipients like preservatives to polymer characterization
- Emulsions and nanosuspensions to elastomeric drug-eluting devices.
Integrated with formulation
Our method development and validation team works closely with our formulation teams to tailor methods to the desired end formulation.
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 experienced formulation team employs a data-driven approach to find solutions for even the most challenging APIs. We employ 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 have over two decades of experience developing and validating release assays for a variety of drug products, including semi-solid formulations, implantable devices, and oral solid dosage forms. Our GMP/GLP facilities are equipped with specialized equipment and seasoned analytical scientists who perform both routine and custom drug release testing.
We are adept in working with complex dosage forms, ranging from intravitreal injectables to topical nanosuspensions to long-acting implantables. Our data-driven approach allows us to develop a robust characterization plan for your product.