Edinburgh, Scotland

Center of excellence for the development and manufacture of specialized drug products based on liquid-filled hard capsule (LFHC) technology

Our Edinburgh facility is one of the world's largest dedicated sites for the design, development and manufacture of liquid and semi-solid pharmaceutical products using liquid-filled hard capsule (LFHC) technology. The site is fully integrated and supports all aspects of product and process development, scale-up and manufacture of LFHC products. The Lonza Edinburgh team has over 25 years’ experience in developing and commercializing these innovative products using LFHC technology and specialized production techniques.

LFHC technology is utilized to address a number of formulation challenges including:

• Poorly soluble compounds using lipid / solvent / co-solvent based formulations
• Safe handling and consistent dosing for highly potent / low dose applications
• Targeted delivery to the colon
• Abuse deterrent formulations 

LFHC technology also offers a rapid formulation tool for first-in-human studies and is an integral part of our SimpliFiH™ Solutions package. LFHC formulations are typically used for solubility and food effect challenges associated with highly lipophilic compounds.

Pharmaceutical LFHC products are also developed and manufactured at our Ploermel France location. Additional LFHC development and production sites for the consumer health & nutrition markets are located in Colmar (France) Greenwood (US) and Sagamihara (Japan). Best practices related to product development and process development, capsule filling and sealing, and scale-up are routinely shared within our LFHC network.

Manufacturing and expertise

We have pioneered the use of liquid-filled hard capsule technology for addressing complex formulation challenges. Our focus on science & engineering has also led to the development of proprietary equipment and processing techniques to improve the efficiency, reliability and productivity of our LFHC manufacturing.  Specialized filling and sealing or banding techniques are in place which ensure leak-free performance.

Our product development teams utilize an array of pharmaceutically-approved lipid and non-lipid excipients, offering unprecedented formulation flexibility in meeting target product profiles.  Flexibility in development and manufacturing is also in place, ensuring rapid scale-up from concept to clinical and commercial production:

• Dedicated non-GMP development suites
• Pilot and commercial scale GMP production lines
• Multiple production lines with capacity > 100M LFHC dosage forms / year
• Specialized isolation capabilities for HPAPI and cytotoxic applications (OEB 4-5)
• In-line printing capabilities
• Specialized capsule coating capabilities
• Primary and secondary packaging

Lonza Edinburgh is approved by the FDA and holds a manufacturing license from MHRA.

Low dose / HPAPI applications

Highly potent compounds proliferate the drug development pipeline.  LFHC formulations offer a safe, simple and efficient formulation approach for oral dosing with low dose / HPAPI applications. Dose consistency is better ensured using liquid fill vs. powder formulation approaches, and operator safety is also assured through the avoidance of powder handling. Lonza Edinburgh has extensive experience and capabilities in the efficient development and manufacture of LFHC products based on HPAPI.