Tampa, Florida, USA

Capsugel is an award-winning global contract manufacturing and development organization and its Tampa facility offers unparalleled expertise in micro-dosing. The company’s Tampa facility is home to an industry-leading Center for Excellence in PIC Technology, where its Xcelodose™ Precision Powder Micro-Dosing systems and market-leading experience in micro-dosing enable premier PIC evaluations and services for preclinical studies. In addition, the Tampa staff offers a full range of services from preformulation and formulation development through small-scale clinical commercial manufacturing, including packaging of clinical supplies, specialized analytical services, and logistics.

Capsugel’s Xcelodose Precision Powder Micro-dosing Systems, which were developed and advanced at the Tampa facility, are the industry standard for enabling accurate and rapid PIC studies. They allow precision weighing of APIs into capsules from 0.1 mg to 20 mg per dose, depending on the physical characteristics of the API and the capsule size. Best-in-class filling accuracy (2% RSD) is achieved at typical speeds of 200 to 250 capsules per hour, depending on dose specifics. Xcelodose systems also accommodate the widest range of fill material as well as the widest array of receptacle types including capsules, vials, and bottles.

With five Xcelodose units in the U.S. and two in Europe at Ploërmel, France, Capsugel can handle highly potent active pharmaceutical ingredients (HPAPIs) up to occupational exposure bands (OEB) 4 and 5 in both North America and Europe.

At Tampa, Capsugel offers a suite of preformulation and formulation services, ranging from expertise physiochemical testing to screening drug compounds in support of drug substance and drug-product development programs. In addition to the PIC/PIB technology, these tests allow us to help our clients identify the most suitable formulation options for their compound and to make early decisions on compound advancements.

Capsugel’s Tampa facility specializes in Phase I through III Good Manufacturing Practice (GMP) manufacturing for clinical trials and small-scale commercial manufacturing. Our manufacturing capabilities include tablets and capsules, liquid in capsule and non-sterile liquids. 

Full analytical services are also available, including analytical method for development and validation. With more than 20 analytical chemists on staff, our analytical team is committed to providing our clients thorough and expedient methodology to ensure quality of their API and drug products. 

Our analytical development services include

• API characterization,
• preformulation,
• analytical method development and qualification,
• phase-appropriate method validation,
• method transfer,
• protocol-driven stability studies,
• release testing, and
• reference material qualification and characterization.

The Capsugel staff in Tampa provides global clinical supplies packaging, distribution, and logistics for clients. Our global distribution capabilities include

• shipment of temperature controlled products worldwide,
• development of customized distribution protocol,
• partnership and integration with third-party IRT (IVRS/IWR) systems,
• international depot setup.

In addition, we have cold-chain capabilities that include 2°C to 8°C storage and dry ice.

Capsugel also provides point of distribution (POD) labeling and distribution.

Our clinical supply storage (cGMP) and retains capabilities include

• retain storage;
• ambient storage, controlled room temperature (20°C to 25°C);,
• cold chain storage, walk in refrigerator (2°C to 8°C);
• cold chain storage, freezer (-20°C); and
• controlled substance/DEA storage (DEA II-V).

We have expertise in clinical returns, reconciliations, and destruction.

Capsugel-Tampa offers complete primary and secondary packaging services in support of a broad spectrum of clinical projects. This also includes worldwide distribution, storage, and logistics under climate-controlled conditions, and clinical retains, returns, accountability, reconciliation, and destruction. In the U.S. and the U.K., investigator-initiated/lead trials (IIT/ILTs) management and supply and QP release services are available.

Our primary clinical packaging services for oral solid dosage forms include the following.

• Bottling 
  • Bottle filling with a wide range of containers and closures
  • Desiccants
  • Induction sealing
  • In-line printing (including UV technology)
• Blister packaging 
  • Thermoform
  • Cold form
  • Multi-product primary packaging
  • In-line printing (including UV technology)

Our primary and secondary packaging and labeling services include custom clinical packaging solutions, such as

• labeling for a multiple variety of primary containers (i.e. bottles, vials, syringes, inhalers, sachets, pouches and medical devices); 
• kit assembly including ancillary supplies; 
• blister card/wallet sealing;
• comparator sourcing; 
• cold room labeling; and 
• clinical labeling (single, multi-panel, booklet, multilingual).