“We focus on bringing our client's products from drug discovery and advancing them to our clinical manufacturing area by developing an appropriate product specific formulation and a robust lyophilization process. Our goal is to move the product through to making clinical material in a seamless streamlined process. We achieve this with high quality due to the truly exceptional team of dedicated people I work with every day.”
– Carrie Shults, Research Scientist, Group Leader
Development and Process Laboratories
Development services are conducted with a product quality and manufacturing mindset. This entails considering product administration, stability and processing requirements from the start. Clients and project sponsors realize numerous benefits from the focus on lyophilization, with access to a comprehensive range of services available from a single source.
Low temperature thermal analysis (LT-TA) evaluates the bulk solution behavior during freezing and drying using varied thermoanalytic techniques at low temperatures. The goal is to quantify critical thermal transitions in preparation for freeze drying. This activity provides significant data and warrants focus as a distinct step in the development process. Learn more.
The route of administration and other unique requirements of the product are considered during whole product design. This approach ensures the final product is practical and efficient, in addition to effective, in order to limit changes during the lifespan of the product. Taking advantage of great relationships with vendors of varied container closure systems and other industry experts, LTI can assist in conceiving, selecting and/or evaluating a wide range of potential product designs to meet your needs.
Based on the physico-chemical requirements of the active compound, multiple variations of a formulation are investigated to yield a preparation having superior finished product attributes and adequate long term stability.
Cycle Design / Refinement
LTI is an expert in establishing processing procedures for clients that are safe, effective, and sufficiently robust for integrating into commercial manufacturing. Process refinement, troubleshooting, and aid in technical transfer are additional services we conduct.
Lyophilized finished product should be evaluated for critical quality attributes (CQAs) specific to a lyophilized preparation. This can include physical appearance, quality of the constituted solution, residual moisture content and thermal properties. Learn more.
Isolation / Containment
LTI is uniquely equipped to handle highly potent toxic and biohazardous materials. From product characterization and cycle design to scale-up and clinical trial material preparation, we can safely and effectively meet your containment needs.
Pilot Plant Scale-up
Scale-up of an early stage manufacturing process provides unique challenges. LTI conducts all development studies with a manufacturing mindset from the start and is uniquely adept at facilitating the technical transfer process. From Development through Clinical Trial Material preparation, lyophilization occurs in pilot and small manufacturing size units with comprehensive automation and process monitoring. This allows for aid in scale up and technical transfer.
Toxicology materials, requiring controlled bioburden conditions, are prepared with care in order to meet your pre-clinical needs. There is also the option to manufacture sterile toxicology materials in the GMP sterile suite of the Clinical Manufacturing Area.
Dedicated / disposable product contact items/equipment
Batch sizes to 40L (Aqueous / Organic Solvents)
Vials from 2 to 160 mL and novel delivery systems
Cartridges/syringes from 1 to 50 mL - Video
Bulk Lyophilization or Drying
Containment capabilities for handling cytotoxic/high potent APIs including biologics and oncology products
Lyophilizers ranging from 2 m² to 24 m² (ISO 5 / Class 100 Environment)
ControLyo™, Nucleation On Demand
DEA Registration to handle Controlled Substances
Our distinct GMP compliant, development and process laboratories are well equipped for conducting a diverse range of experiments encompassing formulation development, cycle design, process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale manufacturing environment. Critical areas for fill/finish are all within a certified HEPA environment, emulating aseptic operations for sterile product. Our comprehensive development reports readily support your regulatory submissions.
To get your project started or to see how a project progresses at LTI, click here.