Tampa, Florida, USA

Service center for formulation, clinical and commercial manufacturing

Our facilities in Tampa (FL) US are an integral component of our design, development and manufacturing network for drug substances and specialized drug products. Working collaboratively with our customers, our Tampa team designs, develops and manufactures tablets and encapsulated formulations for immediate and modified release applications. The site provides a full range of services from preformulation and formulation development through clinical and commercial scale production of specialized drug products, inclusive of analytical method development, and packaging and logistics services for clinical supplies.

Tampa also serves as our US Center of Excellence for rapid first-in-human services utilizing Powder-in-Capsule (PIC) and Powder-in-Bottle (PIB) formulations based on our proprietary Xcelodose® Precision Powder Micro-Dosing Technology. Together with our European PIC Center of Excellence in Ploërmel France, Lonza has Xcelodose® capacity in place for non-cGMP development studies and cGMP clinical manufacturing. Larger scale encapsulation (Harro Hoefliger Modu C) processing is also in place to ensure accelerated pathway to commercialization where required. 

Services

At Tampa, we provide a full suite of development and manufacturing services inclusive of clinical packaging, labeling and logistics.

Our preformulation and formulation services are tailored to your needs and range from physicochemical testing to screening drug compounds. In addition to our powder-in-capsule / powder-in-bottle micro-dosing services, these tests facilitate the identification of the most suitable formulation options for your compounds.

Lonza-Tampa specializes in non-GMP development and in phase I-III cGMP manufacturing for oral solid and inhaled applications. Immediate and modified release tablets and encapsulated powder and multiparticulate formulations are routinely developed and manufactured. Our GMP processes include:

• Compounding
• Blending
• Milling and micronization
• Direct compression
• Wet and dry granulations
• High shear granulation
• Extrusion / spheronization
• Fluid bed coating and drying
• Bilayer tabletting
• Pan coating

Full analytical services are available for analytical method development and validation, inclusive of:

• API characterization
• Preformulation
• Phase-appropriate methods
• Method transfer
• Protocol-driven stability studies
• Release testing
• Reference material qualification and characterization

Our clinical supply services provide comprehensive, global solutions for your clinical trial needs. We provide primary and secondary packaging across a broad spectrum of clinical projects. This includes worldwide distribution, storage, and logistics under climate-controlled conditions, and clinical retains, returns, reconciliation, and destruction services.

• Primary packaging for oral dosage forms using bottling or blister packaging
• Secondary packaging and labeling services
• Kit assembly including ancillary supplies
• Blister card / wallet sealing
• Comparator sourcing
• Cold room labeling
• Clinical labeling options

Our clinical supply solutions offering includes:

• Cold chain storage
• Shipment of temperature-controlled products worldwide
• Controlled substance storage
• Customized distribution protocols
• Integration with third-party IRT systems
• International depot set-up
• Clinical returns, reconciliations and destruction

PIC center of excellence in FIH studies

Our Tampa site has been a pioneer in the utilization of Lonza Xcelodose® Precision Powder Micro-dosing Systems for rapid FIH studies utilizing powder-in-capsule (PIC) or powder-in-bottle (PIB) approaches. By eliminating the need for excipients and associated studies, we have found that phase I studies can be reached 45% faster than alternative formulation approaches. PIC/PIB capabilities are a key component of our SimpliFiH™ Solutions first-in-human services which integrate drug substance, particle engineering, technology selection and phase-appropriate drug product for phase I studies.

Xcelodose® technology has proven capabilities to precisely and consistently dose capsules from 0.1 to 120 mg at less than 2% RSD. This micro-dosing capability facilitates rapid FIH studies for candidate compounds and especially suited for highly potent / low dose applications.

Together with our Ploërmel, France facility in Tampa serves as a Center of Excellence for PIC/PIB studies utilizing ten Xcelodose® systems under development and cGMP conditions, and is capable of accommodating HPAPI applications to OEB 4/5. Our Tampa team has developed best practices based on PIC/PIB studies over more than 700 batches across a range of molecules and formulation challenges.

Working with Lonza, you gain access to premier PIC/PIB evaluations, as well as full development, analytical, manufacturing and clinical supply services to support your early phase work. Our integrated services provide for a seamless commercial pathway, transferring PIC evaluations to later phase clinical / commercial manufacture for PIC formulations or tableting.

Reach IND submission in 12 weeks

Using our Xcelodose® systems and services, we can provide an IND package in 12 weeks from receipt of API. This service offer includes 4000 capsules across two dosage strengths, and all supporting CMC documentation for IND/IMPD submissions. Additional services are tailored to your specific needs and drug program.

*Tampa experience