FEATURED ARTICLES

  • The Process Map To Ensure Biopharma Raw Materials Supply

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

WHITE PAPERS & CASE STUDIES

  • High Concentration Monoclonal Antibody Drugs Manufacturing Challenges

    A review of high-conentration mAb manufacturing challenges including viscosity, aggregation, instability, and the effect of excipients on formulation, filtration, and fill and finish and bioavailability.

  • Agglomerate-Free Dispersion For Hand Sanitizers

    Obtaining an agglomerate-free dispersion is essential to ensure a clear, bright gel after neutralization but low density powders such as Carbopol can be difficult to incorporate into liquids with a conventional agitator. The high shear mixing of a Silverson mixer ensures rapid incorporation and dispersion of powders to form an agglomerate-free solution, with minimized aeration.

PRODUCTS & SERVICES

The patented loading system for freeze dryers ensures maximum process safety, while saving a considerable amount of space. Thanks to its new front pusher design, the system loads vials into the freeze dryer using the linear pushing and pulling motion of a transfer arm. Unlike other systems, the innovative transfer bar is not moved by a hydraulic push rod, but by a mechanical servo drive.

Pharmatec Process Systems for Biopharmaceutical Production are designed for the production of liquid medicines. Production of pharmaceutical liquids is carried out in temperature-controlled stainless steel tanks with stirring units under addition of chemicals with or without nutrient solutions. All valid pharmaceutical (e. g. USP, EP) and technical rules and standards (e. g. DIN, ASME, GMP and FDA / ISPE Guidelines) are followed and applied.