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  • Tampa, FL, USA

Tampa, FL, USA

At our facility in Tampa we provide a full suite of development and manufacturing services inclusive of clinical packaging, labeling and logistics. We specialize in non-GMP development and 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.
4910 Savarese Circle
Tampa, Florida 33634
United States of America

25+

Years

Part of the Lonza network since 2017.


300+

Molecules

Supported in drug product development and clinical trials.


~200

Employees

Skilled people, dedicated to excellence, creating the medicines of tomorrow.


Contact us
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.

front of Tampa building with flags

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.

FormulationCapsule or bottle fillingAnalytical
Meet the expert

“Tampa is the center of excellence for all Powder in Capsule needs using the Xcelodose® system; spanning from development to manufacturing.”

Mark Cappucci serves as the Preformulation Team Lead at Lonza’s site in Tampa, Florida, USA. He has more than 23 years of experience in the pharmaceutical industry, with expertise in areas including drug substance characterization, polymorph identification, and microdosing techniques using Lonza’s Xcelodose® system. Mark joined Lonza in 2004, after working for Amgen and Bausch & Lomb in positions of increasing authority. He received his B.S. in Chemistry from The Ohio State University.
Mark Cappucci

Pre-Formulation Team Lead

Learn more about Mark

Technologies available at this site

Inhalation Formulation Development Services
Particle engineering is critical in achieving the particle size distribution required for effective...
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Drug Product Technologies
Specialized technologies to help you solve your drug product problem statements.
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Micro-dosing for early human clinical studies
Micro-dosing for powder-in-capsule / bottle evaluations can accelerate your phase I & II studies....
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Compatible state-of-the-art equipment

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.

Tampa equipment

Integrated with OPTEL PharmaProof vision system and OPTEL Semi-Automated Pack station-fully capable of serializing and aggregating bottles or blisters in cartons.

Tampa equipment

Sustainability

A recognized, reliable and sustainable partner


We continually strive to reduce our impact on natural systems and the environment, conserve energy and resources, assure safety, health and wellbeing of our employees and help to improve the quality of life in the communities in which we operate.

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