A flexible approach to formulation

Micro and Nanotechnology

LLS Health is a leader in the fields of micro and nanotechnology for pharmaceuticals. We don’t take a one-size-fits-all approach; we design programs based on each individual molecule and overall end goals of the drug product.

Our scientists have extensive experience in developing microsphere and nanoparticulate suspensions, and we are uniquely positioned to transfer in proprietary or academic technologies/processes and bring them into GMP production. When it comes to solubility enhancement, we are the leaders in the use of nanomilling, employing both commercial milling equipment and our own proprietary mills.

This flexibility in formulation and process design combined with access to cutting edge technologies ensures the best possible outcome for your drug product.

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Broad offerings, deep expertise

LLS Health employs several micro and nanotechnology approaches during formulation selection. This allow us to consider different options to achieve your technical and commercial goals. Once we develop a formulation, we have the facilities and equipment to produce clinical and commercial-scale materials for all phases of drug development.

From improving bioavailability or stability, formulating higher doses, improving safety and patient compliance, managing toxicity, controlling release rates, or protecting unstable APIs from degradation, we can create a viable formulation that is scalable and effective.
Our expertise include the following technologies:

  • High energy media milling and micronization
  • Emulsion-solvent evaporation/extraction
  • Homogenization
  • Microfluidization
  • Tangential flow filtration (TFF)
  • Spray drying
  • Augmented drip casting
  • Lyophilization
  • LyoCells®

We have experience in manufacturing microparticle depot injections and developing nanoparticulate suspensions for a wide variety of projects involving new chemical entities (NCEs) and generics—505(b)(2)s and ANDAs. Our deep expertise in complex formulations and breadth of technologies make us ideally suited to take on unique challenges.

Decades of experience

We were one of the first companies to scale and commercialize a nanoparticle with our work on zinc oxide (Z-Cote®) for skincare products in 1990s. Over the years, our scientists have worked on hundreds of nanoparticulate projects, including highly potent APIs and controlled substances.

Expert in long-acting drug delivery

We are expert in the development of bioabsorbable microparticles to achieve long-acting drug release. Our team has strong relationships with the leading suppliers of bioabsorbable polymers and the leading equipment manufacturers for microparticle production and processing.

Aseptic and sterile capabilities

We are the only CDMO that can perform nanomilling under aseptic conditions, including commercial production, and our cleanroom facilities are equipped with processing space that can accommodate even the most complex microparticle production lines.

LLS Health is a leader in nanomilling—an efficient, reproducible, and scalable approach for improving the rate of dissolution and bioavailability of BCS Class II and IV compounds. In just 8 weeks, our Nanomilling Feasibility Program (NFP) allows us to:

  • Develop a target product profile and screen your API for nanomilling with GRAS excipients
  • Generate particle size distribution and short-term stability data for each formulation
  • Identify promising formulation(s) and provide material for small animal pharmacokinetic (PK) studies.

Nanomilling is a proven, commercially-validated process for formulating just about any poorly water-soluble API. Numerous BCS class II and IV APIs have benefited from this technology and 10+ nanomilled drug products have gained FDA approval since 2000, including both solid and liquid dosage forms. The key to nanomilling is particle size reduction, which increases the surface area of an API and improves dissolution rate.

LLS Health has decades of experience developing nanoparticulate suspensions, and we are the only CDMO capable of performing nanomilling under aseptic conditions. If you choose to move forward with your nanomilling project, we have the personnel, facilities, and equipment to produce clinical and commercial scale nanomilled formulations. If you have an insoluble API, contact us today to learn how nanomilling can help to solve your formulation challenges, and let us take your product from concept to commercial.

Supporting 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.

Formulation

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.

Clinical Manufacturing

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.

 

Commercial Manufacturing

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.