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- About Us
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:
Full analytical services are available for analytical method development and validation, inclusive of:
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.
Our clinical supply solutions offering includes:
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.
Pre-Formulation Team Lead
We offer a comprehensive range of hard capsule filling equipment for R&D investigations, clinical batches and commercial scale applications. For a comprehensive equipment list, please contact us.
Fills hard capsules with powder, tablets, micro-tablets, pellets, capsules or combinations. Precise weighing guarantees highest quality products.
Integrated with OPTEL PharmaProof vision system and OPTEL Semi-Automated Pack station-fully capable of serializing and aggregating bottles or blisters in cartons.