Bend, Oregon, USA

Center of excellence for bioavailability enhancement & drug delivery

Our team in Bend, Oregon (US) specializes, among other things, in addressing solubility challenges and modulating pharmacokinetics to meet target product profiles. The Bend site has specialized expertise, capabilities and infrastructure for spray-dried dispersion (SDD) technology which is increasingly being utilized for advancing poorly soluble molecules (BCS II compounds). A full range of oral drug delivery technologies and processing is also in place for modified and targeted release requirements in monolithic or multiparticulate formats.

The Bend site is staffed and equipped to support you throughout the entire lifecycle of your candidate, from preclinical and first in human to late-stage development and commercial production of drug product intermediates (SDD) and finished drug products.

Spray-dried dispersion technology

Spray-dried dispersion (SDD) technology was pioneered by Bend Research, now Lonza, and is now an intregral part of our integrated drug development services and network. SDDs are single-phase, amorphous molecular dispersions of a drug in a polymer matrix and are obtained by dissolving drug and polymer in an organic solvent and then spray-drying this solution. SDDs have a broad application space across BCS II molecules and demonstrate long-term stability, facile scale-up and excellent manufacturability. Hot melt extrusion (HME) technology is another solid amorphous dispersion option, with the choice between the technologies dependent upon API characteristics, target product profile and/or commercial objectives.

This expertise in particle engineering has been utilized in creating a full-service offering for dry powder inhaler (DPI) formulations. DPI formulations are designed to meet target product profiles using jet milling and/or spray drying. Our integrated services include phase-appropriate encapsulation and specialized analytical services.

Services

We provide integrated services across the design, development and manufacturing of particle-engineered intermediates and specialized drug products. An emphasis on the interaction of formulation physicochemical constraints and process definition allows our teams to minimize timelines and risks early in the development process. State-of the art manufacturing facilities and process expertise ensure that you have access to the right technology and processing to progress your molecule.

Core services include:

• API characterization
• Formulation problem definition
• Process development
• Analytical method development and validation
• Technology selection
• Computational fluid dynamics modeling and custom predictive biomodeling
• Development and cGMP production
• Particle engineering using particle size reduction, spray drying and hot-melt extrusion
• Melt spray congeal technology and fluid bed processing
• Functional tablet coating, bi and tri-layer matrices
• Modified drug delivery inclusive of multiparticulate and osmotic technologies

Integrated product development based on fundamental sciences

Product design & development

Our approach is based on fundamental, model-based product and process development at all stages of the drug development process. We address the interaction between formulation physicochemical constraints and process definition to reduce timeline and development risks in early stages. In late stage, process development models are used to ensure efficiency and robustness.  Science of scale studies and engineering expertise have been utilized to develop specialized processing equipment and techniques to ensure rapid evaluations and scale-up.

The Bend team is integral to our network of product development sites in the US and Europe, where we share best practices to identify optimal technologies and solutions for your specific bioavailability and/or drug delivery challenges.

Manufacturing program:

Our manufacturing facilities and process expertise in Bend give manufacturing facilities and process expertise give our customers access to the right technologies and services to advance their molecules. Manufacturing support is phase-appropriate and tailored to your specific molecule and drug program.

• drug product intermediates and formulations at bench scale for early feasibility work in our laboratories 
• pilot scale quantities of intermediate or drug product
• clinical and commercial supplies in our Good Manufacturing (cGMP) manufacturing facility, specialized in SDD intermediates and oral dosage-form manufacturing
• support drug product intermediates (e.g. SDD, HME) to solid oral dosage forms (tablets, encapsulated products)
• phase-specific supply: production from kilogram to metric tons
• commercial-scale SDD and drug product to support registration lots, commercial launch programs and ongoing supply