Long-Acting Drug Delivery CDMO
Long-acting drug delivery systems, such as implants and combination products, are an increasingly popular approach for sustained drug delivery, offering the potential for targeted drug release, lower dosage requirements, and improved patient compliance. A well-designed drug-eluting system can positively impact bioavailability, stability, and pharmacokinetics of an active pharmaceutical ingredient (API) while also offering potential intellectual property and life-cycle management opportunities.
Experienced with a range of polymers and APIs
The Health business of Lubrizol Life Science (LLS) is a leading solutions provider for long-acting injectables and implants. Whether you are looking to design a novel drug product, create a generic (505(b)(2), ANDA), or add a drug to an existing medical device to improve performance, we are here to help.
LLS Health is equipped with the technologies and expertise to handle the design, formulation, and production of long-acting drug delivery systems, including those that contain highly potent APIs (hormones, steroids, cytotoxics), controlled substances (Schedule I-V), and large molecules (proteins, peptides, nucleotides).
We understand the importance of polymer control and supply for drug-eluting systems and have established strong relationships with the world’s leading suppliers of biodurable and biodegradable polymers. We regularly work with poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), thermoplastic polyurethane (TPU), ethylene vinyl acetate (EVA), and silicones (LSR and HCR). LLS Health can assist in polymer evaluation and selection of the proper grade to support a combination product.
We handle both large and small molecules and work on a broad range of long-acting drug products, including:
- Antiretroviral-loaded intravaginal rings
- Hormonal subcutaneous implants
- Long-acting injectable suspensions
- Drug-eluting pacemaker leads
- Drug-coated balloon catheters
A breadth of formulation and manufacturing capabilities
Long-acting drug delivery systems are complex products that can take several forms, including implantable and injectable preparations. LLS Health utilizes a range of techniques to design formulations that meet our customers’ target product profiles. Whatever the goal of a drug-eluting system, the drug incorporation method, material selection, and product performance is optimized by our experienced team to achieve the desired drug release rate. Our in-house formulation and manufacturing capabilities include:
- Extensive statistical-based modelling
- Hot melt extrusion (HME)
- Co-extrusion (core-sheath devices or multi-layer extrusions)
- Injection molding
- Cryo-milling and jet milling
- Surface dip and spray coating
- High-shear mixing
Taking your long-acting drug delivery system from concept to commercialization
Complex drug product manufacturing is performed in on-site clinical and commercial GMP manufacturing suites, including dedicated cleanroom space for processing highly potent APIs. We are experts in bringing processes into a GMP environment, whether through a technology transfer or as part of a larger development project.
Both our formulation and manufacturing efforts are supported by a full suite of analytical and bioanalytical services. Our analytical staff specialize in method development and validation and focus on critical quality attributes such as in vitro drug elution and chemical stability. They also support both our accelerated and long-term ICH stability programs. Together, our formulation, manufacturing, analytical, and quality teams comprise a multidisciplinary team dedicated to your success.
We have decades of experience in the design, development, manufacturing, and characterization of drug-device combination products, including those that contain highly potent APIs and controlled substances. We offer advanced modeling tools, polymer processing, and sterile manufacturing to support new chemical entities, 505(b)(2) applications, and ANDAs.
We employ several nanotechnology approaches, designing custom programs around specific APIs and client goals. Our team is uniquely positioned to transfer in proprietary technologies or processes and bring them into GMP production. We can produce nanoparticle dosage forms under aseptic conditions at clinical and commercial scale.
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 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.