Manufacture of clinical trial materials

Project management

A project manager is appointed for each assignment and is responsible for coordinating all activities. The project manager is your main contact at APL during the project. We carry out all activities, such as planning, purchasing raw materials and packaging materials, designing specifications and preparing for transport.

Aseptic, sterile and non-sterile

APL manufactures clinical trial medicines and placebos in most dosage forms. On our GMP-classed manufacturing premises, we carry out aseptic, sterile and non-sterile filling of products. Injections are always filled using a sterile and aseptic method. If the product to be filled is temperature sensitive, it is always filled aseptically.

Automatic or manual filling

How the product is filled is also determined by the clinical trial requirements, the stability of the product and the method of transport to a trial site.

Different amounts of filled units are required, depending on how many patients or trial subjects are included in a clinical trial. In most cases, the most cost-effective method is to fill them automatically using a filling line. For a small trial, we can fill products manually.

Randomizing

At a clinical trial, the active trial medication and the corresponding placebo are usually given in a randomized order. We can randomize, label and package for single-blind or double-blind trials, or crossover trials.

• Double-blind: To achieve the greatest possible scientific credibility, a trial is randomized so that neither the trial subjects nor the trial manager know which subjects are given the active trial medication or the placebo.
• Single-blind: Here, either the trial subjects or the trial managers are unaware of which subject in the study receives the trial medication or the corresponding placebo.
• Crossover study: The trial subjects are given both the active trial medication and the corresponding placebo at different stages of a study.

Labeling

The manufactured products are marked with a label that links them to a list and only an independent party knows which trial subject receives which treatment in the study.

Packaging

The labeled products are placed in secondary and transport packaging for transport to the trial site or to a distribution center, which transports them to the trial site.

Analysis

Every manufactured product goes through a predefined list of analyses to safeguard the product’s quality and identity. These analyses are carried out at a quality control (QC) laboratory, which is independent of the manufacturing facility.

QP

When the analysis is completed, our certified Qualified Person (QP) carries out a detailed review of all documentation associated with the reception of raw materials, manufacture and analysis of the product. If all has been done according to GMP and corresponds to our standard operating procedures (SOPs) and instructions, the product is released for a clinical trial. We release products to be used in clinical trials approved by the European Medicines Agency (EMA) or other recognized health authorities globally.

We have one or more QPs at each manufacturing facility.