Powders for Injection, Inhalation, and Oral Applications
LLS Health is experienced in the development of dry powder formulations. We work with you to develop formulations to be administered in a range of delivery devices, regardless of whether they are proprietary or commercially available.
Powders for all routes of administration
LLS Health can develop powder formulations for all routes of administration, including sterile powders for reconstitution and injection, nasal inhalation, and oral. Our expertise in complex formulations means that we are uniquely positioned to design powder systems that deliver the desired target product profile and overcome obstacles such as poor water solubility.
Lyophilized powders for injection
We offer lyophilization from R&D through clinical and commercial scale. Our team is strong in developing lyophilization cycles for both standard solutions and complex drug products such as nanoparticles, liposomes, and biologics. We are equally adept at technology transfers and bringing those processes into GMP production. Our formulation, manufacturing, and analytical teams work closely together to ensure chemical and physical properties are maintained throughout process development and scale-up. And our commercial lyophilizer has both Clean-In-Place and Steam-In-Place capabilities, allowing for aseptic processing to manufacture sterile powders for reconstitution.
LLS Health is also experienced with dry powder formulations for nasal administration. Previous work in this area includes the formulation development of a BCS II drug substance by nanomilling and spray drying with an inert carrier that produced a larger particle size. This formulation demonstrated effective nasal deposition and eliminated unwanted delivery of the API into the patient’s lungs.
LLS Health is the world’s largest manufacturer of pharmaceutical-grade carbomers (Carbopol® products) and polycarbophil (Noveon® AA-1). We have been manufacturing pharmaceutical excipients for more than 40 years and have experience formulating and characterizing powders for oral solid dosage forms. We provide granulation, fluid bed coating, spray drying, jet milling, nanomilling, and lyophilization services.
We understand the physical and chemical properties that make biopharmaceuticals and biosimilars different from small molecules. Our team is adept at formulating large molecule therapeutics such as proteins, peptides, and oligonucleotides while maintaining biological activity. We also offer characterization, formulation, and aseptic manufacturing services.
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.