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 formulations need to be adjusted in terms of 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, such as mixing, homogenising and filling the products. 

Knowledge transfer

We transfer knowledge on production formulation, manufacturing processes and QC (Quality Control) analyses and also on raw materials and primary packaging materials. This information may come from another manufacturing unit or from a development laboratory. In some cases, further development and supplementing of the various steps are necessary to adapt them to new manufacturing conditions. A close dialogue between specialists within the various areas is often needed to ensure all details agree.

Approved suppliers

Our special 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 both official pharmacopeias (Ph Eur, USP, BP, etc.) and according to adapted
specifications. The methods are developed and validated according to applicable ICH guidelines.

Batch protocols

All our medicines 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 is 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 primary packaging selected, such as bottles, vials or tubes, and then sealed.

We label and pack the filled units for onwards transport.

QC laboratory

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. By far the most analyses are carried out at APL. In some cases, we outsource analyses to approved suppliers.

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.