What is Clinical Manufacturing & How Do CDMOs Help Develop FDA-Approved Clinical Trial Materials?

• 1. Have a written pharma quality control plan.
• 2. Maintain a controlled, sterile environment.
• 3. Record accurate and consistent data from the manufacturing process.

Routes of Delivery

Below are the areas that we focus on at UPM:

• Oral (solid and liquid): Taken by mouth, either as tablets, capsules, liquids, or powders.

• Injection: Injected through a needle and syringe. This can be subcutaneous, intramuscular, or intravenous.

• Topical: Applied directly to the skin or mucous membranes.

• Inhalation: Drugs are delivered to the lungs through inhalation, commonly as aerosols or dry powder.

• Transdermal: Delivered through patches or creams applied to the skin, allowing absorption into the bloodstream.

• Inhaled (pulmonary): Administered through inhalation into the lungs using devices such as inhalers or nebulizers.

• Inhaled (nasal): Delivered through the nasal passages using nasal sprays or inhalers.

• Rectal: Drugs are introduced to the body through the rectum, either as suppositories or enemas.

• Intrathecal or Intraventricular: Delivered directly into the spinal canal (intrathecal) or ventricles of the brain (intraventricular).

• Intra-articula: Injected directly into joints, often for the treatment of localized conditions such as arthritis.

Below are the other routes of Delivery that are available in the market: 

• Sublingual and Buccal: Drugs are placed under the tongue (sublingual) or against the cheek (buccal) for absorption through the oral mucosa.

• Intravenous: injected directly into the bloodstream through a vein.

• Parenteral: any route of administration that does not involve the digestive tract, such as intravenous, intramuscular, subcutaneous, or intradermal.

• Intramuscular: injected directly into a muscle.

Phases of Clinical Studies

UPM supports all aspects of your drug product supply for Phase I, II, and III clinical studies:

Phase I

Patient Enrollment:

• Involves 15 to 50 patients.

• Divided into small groups known as cohorts.

Primary Objective: 

• Focus is on safety and proper dosage.

Transition to Phase II:

• Successful completion of Phase I, with an established safe and effective dose, leads to the drug's advancement to Phase II clinical trials.

Phase II: 

Patient Enrollment:

• Typically involves fewer than 100 patients.

Primary Objective:

• Main goal is to assess the efficacy and side effectives of the new treatment.

Transition to Phase III:

• Successful completion of Phase II, with positive efficacy signals and manageable side effects, may lead to the decision to proceed to Phase III clinical trials.

Phase III: 

Patient Enrollment:

• Involves hundreds to thousands of patients globally.

• Patients are randomly assigned to either the control group (standard treatment) or the study group (new treatment).

Primary Objective:

• Test the superiority or non-inferiority of the new treatment compared to the standard treatment.

FDA Review:

• After completion of Phase III, the FDA reviews the clinical trial results.

• Ensures the treatment is both safe and effective for patient use.

Decision for Approval:

• Based on FDA review, a decision is made on whether to approve the treatment for widespread use.