Commercial manufacture

Adaptation

When upscaling, we either adapt the product formulation, the manufacturing process or both, to manufacture a larger batch.

Adjustment

In some cases, the formulation must be adjusted for compatibility between the active substance and excipients, pH levels in the finished product, viscosity and other characteristics.

The manufacturing process is adapted to allow for the critical process parameters and may include mixing, homogenizing and filling of the products.

Knowledge transfer

We transfer knowledge on production formulation, manufacturing processes and quality control (QC) procedures, as well as raw materials and primary packaging materials. This information may come from another manufacturing facility or a development laboratory. In some cases, further development and supplementing of the various steps are necessary to adapt the process to new manufacturing conditions. A close dialogue between specialists in various fields is often needed to ensure all details are correct.

Approved suppliers

Our purchasing team manages the purchase, analysis and release of raw materials and packaging materials for GMP manufacturing. We work exclusively with approved suppliers to safeguard quick deliveries of necessary materials of GMP quality.

Analysis

All raw materials and packaging materials undergo analysis according to official pharmacopeias (Ph Eur, USP, BP and others) and according to adapted specifications. The methods are developed and validated according to applicable ICH guidelines.

Batch protocols

All our medications and medical devices are manufactured on GMP-classed premises. Ahead of manufacture, we produce and approve a batch protocol, which describes step-by-step how the manufacture will be done. The batch protocol is supplemented during the manufacturing process.

Mixing and filling

Manufacture usually consists of two steps:

1) mixing, where the active substance and excipients are melded together into a finished product mix, and

2) filling, where the finished mix is filled into the selected primary packaging, such as bottles, vials or tubes, which are then sealed.

We label and pack the filled units for onward transport.

QC laboratory

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. The vast majority of analyses are carried out at APL. In some cases, we outsource analysis to approved suppliers.

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.