Manufacture of clinical trial materials

Project management

A project manager is appointed for each assignment, who is responsible for coordination of all activities. The project manager is your main contact at APL during the course of the project. We carry out all activities, such as planning, purchase of raw materials and packaging materials, design of specification and preparation for transport.

Aseptic, sterile and non-sterile

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

Automatic or manual filling

How the product is filled is also determined by what is needed in a clinical trial, how stable the product is and how it will be transported to a trial site.

Differing 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.

Randomising

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

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

Labelling

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

Packaging

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

Analysis

Every product manufactured goes through a pre-defined list of analyses to safeguard the product’s quality and identity. These analyses are carried out at a QC (Quality Control) laboratory that is independent from the manufacturing unit.

QP

When the analysis is completed, our certified QPs (Qualified Person) carry 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 SOPs (Standard Operating Procedures) and instructions, the product is released for a clinical trial. We release products to be used in clinical trials approved by EMA (European Medicines Agency) or other recognised Health Authorities globally.

We have one or more QPs at each manufacturing unit.