Clearing the pathway to clinical trials
Pre-clinical Manufacturing Services
LLS Health understands that your goal is to get your drug product into the clinic. Our pre-clinical manufacturing services include R&D, engineering, and GLP test article manufacturing along with full analytical services for sterile and non-sterile products, BCS II – IV molecules, and long-acting drug products such as microsphere depot injections and implants including highly potent active pharmaceutical ingredients (HPAPIs) or DEA-controlled substances (Schedules I-V).
Using a variety of technologies including emulsions, gels, micro and nano-particulates, drug-device combination products, solid solutions and others, we can produce and characterize virtually any dosage form for any route of administration to get you on your way with material suitable for in vitro and in vivo testing. And when you are ready for clinical trial materials we have the infrastructure, quality systems, and personnel to move your product through the clinic and into commercial manufacturing – a complete and seamless development through manufacturing solution.
With you every step of the way
We work closely with you on the path towards clinical trials, from developing and selecting a lead formulation prototype to scaling up for GLP toxicology studies. At LLS Health, we routinely work on challenging projects, including novel drug delivery platforms and new chemical entities (NCEs). For early-stage complex drug products, there may not be FDA guidance or similar drug products to reference. In these cases, we develop new processes to enable progression through the development pipeline.
From the outset of the preclinical phase of your project, we work closely with you to develop a range of formulation prototypes so that you can evaluate them through in vivo and in vitro models. This allows you to efficiently identify a lead drug product formulation.
After that, we have the full in-house capabilities to scale up for manufacturing of GLP test articles along with the appropriate quality assurance (QA) oversight to ensure that all regulatory requirements are met.
Half of our development work is pre-clinical
Half of the development that we do is focused on this crucial pre-clinical phase. We are experts in efficiently evaluating drug delivery approaches to give your molecule the best chance of success and to help you reach key milestones.
A seamless path for complex formulations
We have the equipment, engineering, and facility flexibility to design and produce R&D material for even the most complex formulations, including sterile products, emulsions, and implants.
In-house analytical and engineering capability
Our in-house analytical services start with early stage method development that progresses in parallel with formulation development. Our in-house engineering team then develops scalable processes that enable clinical manufacturing.
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.