Sterile and non-sterile commercial manufacturing for small to medium batch size drug products

Commercial Manufacturing

LLS Health is positioned to fill the market need for commercial manufacturing of smaller batch size drug products as well as the rapidly growing sub-segment of sterile and complex drug products. Our commercial manufacturing facility features purpose-built infrastructure and a highly specialized staff with decades of experience to ensure your drug product gets the care and focus it needs to succeed.

We specialize in the commercial production of a range of dosage forms, including sterile and complex formulations and high-value, lower batch size products such as orphan drugs. We offer flexible, versatile cleanroom space to accommodate your individual project needs—from the simple to the complex – in a dynamic, customer-focused environment.

Help Get My Product To Market

We have the technical know-how and capabilities required to manufacture sterile and complex drug products that simply won’t work with a one-size-fits-all approach.

Flexibility is what sets us apart. We welcome the small to medium commercial batch sizes that other CMOs will not take on, and we pride ourselves on our customer-facing approach. We use our flexible cleanroom space to accommodate both simple and complex processes and procure dedicated equipment where required. We grow with our clients to ensure they have a viable facility for commercial manufacturing—building and acquiring additional capabilities as needed.

Flexible cleanroom space

We offer 3,000 sq. ft. of flexible, purpose-built cleanroom suite space available for your commercial manufacturing project.

Built for small to mid-size batch, sterile or non-sterile drug product

We have flexibile filling capabilities for biologic and small molecule drug products for filling into vials, syringes, cartridges, and bottles.

Customer-focused approach

Our team works closely with you to fully understand your needs and ensure that you achieve the best outcomes for your commercial manufacturing project.

Our commercial facility has a wide range of capabilities built around complex drug product development and manufacturing, including:

  • 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: Our 120 sq. ft. commercial lyophilizer offers both clean-in-place and steam-in-place capabilities allowing for aseptic processing. This builds upon our existing R&D and clinical lyophilization capability, which consists of multiple R&D and small-scale clinical lyophilizers.
  • 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 at a commercial scale.
  • Non-Traditional Dosage Forms: Our background in complex drug product development means that we can handle a wide range of challenging projects that require specialized knowledge, such as nanoparticles, bioabsorbable microspheres, injectable polymeric depots, and lipid-based systems.
  • Fill-Finish Operations:  We manufacture small molecules drug products and biologics such as proteins, peptides, and oligonucleotides, under both sterile and non-sterile conditions, and have filling lines for a variety of containers including vials, syringes, cartridges, and bottles.

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.

ICH-Compliant Stability Programs

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.

Formulation

Our formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing employ 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.