A trusted partner for pharmaceutical drug product manufacturing services and solutions.
Drug Product Manufacturing Services
LLS Health is a trusted manufacturing partner, offering pre-clinical, clinical, and commercial drug product manufacturing (DPM) services along with supporting analytical method development/validation and ICH stability programs. Our production suites are equipped for both sterile and non-sterile products, and we are experts in aseptic manufacturing. We regularly handle challenging APIs, including BCS Class II-IV molecules, DEA Schedule I-V substances, and highly potent compounds using a risk-based approach.
What types of drug products do we manufacture?
At LLS Health, drug product manufacturing (DPM) encompasses pre-clinical, clinical, and commercial production of a wide variety of dosage forms, including powders, topical semi-solids, ophthalmic products, suspensions, long-acting injectables, and implantable drug delivery systems, among others. Projects range from engineering batch or GLP test article production through phase III and commercial production of smaller batch size drug products as well as the rapidly growing sub-segment of sterile and complex drug products. Along the way, projects are supported with robust, phase-appropriate analytical method development/validation and ICH stability programs.
Benefits of LLS Health’s DPM services
With the ability to handle aseptic processes and complex dosage forms, we are positioned to take on the pre-clinical, clinical, and commercial manufacturing projects that other CDMOs and CMOs reject. We offer flexible, versatile cleanroom space to accommodate your individual project needs—from the simple to the complex—in a dynamic, customer-focused environment. Our manufacturing offering was built on a solid, drug product development foundation allowing our clients a single, streamlined solution to help you get your product to market.
Frequently Asked Questions About Drug Product Manufacturing
What is contract manufacturing?
Contract manufacturing is the outsourcing of drug product manufacturing to a third-party. Contract manufacturing services may be employed for engineering batches, GLP test articles, phase I-III clinical trial material, and commercial drug products.
Why should I use contract manufacturing?
Contract manufacturers (CMOs) such as LLS Health allow you to access specialized manufacturing equipment without the capital investment and resource drain of internal production. CMOs often have a breadth of experience in similar products that can help them when troubleshooting challenges and optimizing client processes.
For companies with limited production capacity, CMOs may provide an accelerated path to market by overcoming internal scheduling limitations for clinical trial material and commercial products.
How do I choose a CMO for my drug product?
An ideal CMO should act as an extension of your existing R&D or manufacturing capabilities, treating your product with the same care and attention as you would. CMOs should possess a reliable quality department to ensure adherence to good manufacturing practices (GMP) and an experienced manufacturing team that can quickly and safely overcome production challenges.
What drug products does LLS Health manufacture?
LLS Health specializes in products with small to mid-size batches, including both sterile and non-sterile dosage forms. We’ve manufactured powders, topical semi-solids, ophthalmic products, injectable solutions, and long-acting implantables, among other products.
What manufacturing services does LLS Health offer?
LLS is a flexible CMO that accommodates a range of formulation techniques and will not attempt to shoehorn you into a specific dosage form or technology. We have capabilities for filling biologic and small molecule drug products into vials, syringes, cartridges, and bottles.
In addition to filling operations, we do aseptic production, lyophilization, particle size reduction, and non-traditional dosage form manufacturing (e.g., nanoparticles, lipid-based systems, and extruded polymeric implants).
What types of active pharmaceutical ingredients (APIs) does LLS Health manufacture?
We work with clients to manufacture new chemical entities (NCEs), ANDAs, 505(b)(2)s, and even over-the-counter (OTC) products in a range of dosage forms.
Our team has experience with both small molecules and biologics, and our focus in complex products means we are often working with BCS Class II-IV compounds. We have dedicated suites for highly potent compound handling and our site is FDA registered to work with DEA controlled substances (Schedule I-V).
How do I start a manufacturing project with LLS Health?
For more information about our contract manufacturing services, visit the links above on this page.
To speak with a representative from LLS Health about your project, please fill out our contact form.