The trusted partner that provides solutions from bench to production of sterile & complex drug products
Clinical Drug Product Manufacturing Services
Clinical trials are a crucial phase in the development of your drug product. Having a trusted clinical drug product manufacturing partner on your team to ensure high quality clinical trial supplies is key.
LLS Health offers a breadth of clinical trial manufacturing capabilities that complement our formulation and pre-clinical manufacturing expertise. Our integrated approach offers a smooth transition from the bench to production.
From the simple to the complex, we have a range of technologies and delivery platforms that can accommodate your drug product to achieve your technical and commercial goals.
The clinical drug product manufacture of sterile and complex drug products requires additional expertise to meet GMP requirements.
With the ability to handle aseptic processes and complex dosage forms, we are positioned to take on the clinical manufacturing projects that other CMOs reject. We do not shy away from challenging projects that require more than just an off-the-shelf solution.
As a CDMO that adapts and grows with our clients, we are flexible and innovative in our approach. We will not shoehorn you into a dosage form or technology – we have full service analytical capabilities and a portfolio of drug delivery technologies to find the solution that meets your needs. From there, we can translate robust benchtop formulations into GMP production.
Our ‘can do’ attitude and willingness to think outside of the box enable us to supply high-quality clinical trial material for almost any project.
Ability to handle high potency APIs (HPAPIs)
We have dedicated suites for highly potent compounds and purpose-built containment systems based on isolator technology. We are FDA registered and can work with all schedules of DEA controlled substances (Schedule I-V).
Wide range of dosage forms
We develop and manufacture a wide variety of dosage forms including powders, topical semi-solids, ophthalmic products, injectable solutions, and long-acting implantables, among others.
Strong analytical support
Our Analytical Services group develops robust analytical methods in-house under full cGMPs and in sync with the stage of development.
Our sterile and complex drug product manufacturing capabilities include:
- Aseptic Production: ISO 5 suites for aseptic processing, including filling of vials, ophthalmic bottles, syringes, cartridges, and injector devices. We also have fully closed steam-in-place manufacturing capabilities.
- Lyophilization: We have multiple R&D and small-scale clinical lyophilizers and expertise in developing both complex particulate-based formulations and biologics for lyophilization. If a project progresses into commercial manufacturing, we can scale-up batches for our 120 sq. ft. commercial lyophilizer.
- Particle Size Reduction: We are a leader in nanomilling (wet, dry, and aseptic) and microfluidization technologies. We are the only for-hire organization that can perform nanomilling under aseptic conditions, including scale-up through commercial manufacturing, using our proprietary SteriMill™ technology.
- Polymer Processing: We specialize in drug-device combination product development and manufacturing, including highly potent APIs such as hormones. Our polymer processing capabilities include hot melt extrusion, co-extrusion, and injection molding, and we have established relationships with the world’s leading polymer suppliers, ensuring a seamless path to commercialization.
- Sterile Solutions and Suspensions: We offer comprehensive services in the development and manufacturing of injectable formulations. We are experts at handling both large and small molecules and specialize in developing drug products, such as intra-articular, subcutaneous, or intravitreal injectables.
- Commercial scale-up: With our integrated commercial facility, we can seamlessly transfer your late stage clinical programs into commercial production. However, if preferred, we can also transfer the process to our clients at any stage of the development process.
Supporting Clinical Drug Manufacturing 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 experts in complex sample preparation, and our experienced staff will help you design and execute a phase-appropriate analytical strategy.
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.
Our development and manufacturing services are complemented by well-designed, ICH-compliant stability programs that accommodate a range of temperature and humidity conditions. We have also invested in a state-of-the-art electronic lab management system that enhances data reporting and statistical analysis.