PII

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CTM Manufacturing

With a focus on the science of drug development, our goal is to move the compound from the preclinical into the clinical development stage as quickly as possible.

 

disso Pii manufactures a wide range of dosage forms for CTM supplies to support Phase I-IV studies including:

  • Solid
  • Liquid
  • Semi-solid
  • Sterile (IV, Syringe, and Lyophilized)
  • Inhalation (pMDI and DPI fills)

Pii has the capability to manufacture Clinical Trial Materials (CTM) from less than 1 kilogram to small scale commercial batch sizes.  Pii also provides packaging in bottles and/or blister packs that can be labeled for open and/or blinded clinical studies. Pii is equipped with the expertise, experience, and equipment needed to meet your clinical manufacturing needs.

Our range of equipment and depth of capacity enables us to manufacture clinical trial materials  through commercial production. For oral dosage forms, processing  equipment options include softgel encapsulators, fluid-bed processors, roller  compactors, spray dryers, hot melt extruders, and a full range of compression  equipment including bi-layer and tablet-in-tablet presses. Liquid and  semi-solid processing includes semi-automatic and automatic tube filling. For  sterile dosage forms, capabilities include vial and syringe filling and  lyophilization.  Additionally, our United  Kingdom facility offers development and manufacturing services for dry powder  and pressurized metered dose inhalers (DPIs & pMDIs) as well as intranasal  products. Click here for our current manufacturing equipment list.

Potent Compounds

With state-of-the-art containment suites, Pii is capable of handling specialized compounds including potent APIs and steroids.

U.S. Drug Enforcement Administration (DEA) Scheduled Compounds

Pii can develop and manufacture CTM supplies for schedules I, II, III, IV and V DEA scheduled compounds.

Comparator Supplies

Products can be blinded for clinical studies using over-encapsulation and banded to be tamper-evident.  Matching placebos can be formulated and manufactured for comparative studies.

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