Taking your formulation to the next level
LLS Health understands the physical and chemical properties that make biopharmaceuticals different from small molecules. During formulation, we consider the molecule’s stability requirements, its tertiary structure, and the need to retain biological activity.
The clinical and commercial success of biopharmaceutical products largely depends on the development and validation of robust processes. We are experienced at incorporating these fragile molecules into dosage forms for virtually any route of administration while maintaining biological activity. As with all our formulation offerings, we provide a personalized approach to find the best solution for our clients.
Development, Manufacturing, and Analytical Services
At LLS Health we are adept at the formulation, characterization, scale up, and manufacturing of large molecule therapies such as proteins, peptides, and oligonucleotides. And since most biopharmaceutical molecules are not amenable to terminal sterilization, our facilities are equipped with ISO 5 suites and have isolator technologies suitable for the aseptic processing of these drug products, including lyophilizers in both our clinical and commercial manufacturing suites.
Our biologic characterization techniques range from kit-based protein assays to ELISAs and DNA hybridization assays. We have specialized equipment, dedicated biopharmaceutical laboratory space, and a seasoned analytical staff who carry out development and validation of biopharmaceutical methods for large molecules. We are also accustomed to dealing with the challenges that biomolecules bring to stability-indicating methodology and in vitro release testing.
Taking on the complex
We can tune a delivery profile either to increase bioavailability or to formulate long-acting dosage forms which is key to patient compliance. Some of these concepts translate well into 505(b)(2) products and life cycle management and, in some cases, intellectual property to protect the asset.
Deep expertise in lyophilized products
We are meeting the growing demand for lyophilized complex drug products such as biologics and long-acting injectables. We have both clinical and commercial lyophilizers supported with Clean-In-Place and Steam-In-Place capabilities for aseptic processing.
We support a wide range of dosage forms, while specializing in the parenteral formulations often required for biologic-based drug delivery.
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.
We are experienced in developing, optimizing, and implementing stability indicating methods to reliably measure product performance. Our team focuses on delivering robust analytical data that minimizes risk and supports regulatory approvals.
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.
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.