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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 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) based on our proprietary Xcelodose® Precision Powder Micro-Dosing Technology. We have 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.
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 micro-dosing services, these tests facilitate the identification of the most suitable formulation options for your compounds.
Our Tampa site 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
Worldwide distribution, storage, and logistics
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
We are a pioneer in the utilization of Lonza Xcelodose® Precision Powder Micro-dosing Systems for rapid FIH studies utilizing powder-in-capsule (PIC) approach. 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 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 and low dose applications.
Tampa serves as a Center of Excellence for PIC studies utilizing ten Xcelodose® systems under development and cGMP conditions, and is capable of accommodating HPAPI applications to OEB 4/5. Our team has developed best practices based on PIC studies over more than 2,000 batches across a range of molecules and formulation challenges.