Month: May 2024

Did you know that sterile filtration can cause a negative mass content on detergents?

At ProJect Pharmaceutics, we specialize in conducting process-mock up studies prior to technology transfer to the designated contract manufacturing organization (CMO). In a process mock-up case study about “Adsorption of detergents (kinetics and amount) during sterile filtration”, the detergent content was monitored before and after the first and second round of sterile filtration. The result was identical: the detergent content decreased directly at the beginning of sterile filtration until the filter material was saturated and then reached the initial concentration towards the end of the filtration volume.
To avoid this, follow our expert tip on double sterile filtration:

  • Either discard the first x mL of the compounded, detergent-containing solution, or
  • Precondition the filter material with x mL of the mixed solution.
detergent adsorption filtration

Did you know that according to ICHQ6 guideline the molar extinction coefficient needs to be determined experimentally for a biological drug product at least once?

Determination of the theoretical (!) molar extinction coefficient by the amino acid sequence of a biomolecule is i.a. well known in pharmaceutical industry. However, according to ICHQ6 guidelines the theoretical value ought to be supported by an empirically (!) determined value for the drug product at least once.
At ProJect Pharmaceutics, we are able to determine the extinction coefficient experimentally using an absolute gravimetric determination approach. Thereby, we are able to consider not only the protein primary sequence but also glycosylation as part of the overall protein mass.
If you also need support determining the molar extinction coefficient of your biological product empirically, contact us.

29 ext coeff

Have you ever wondered about the lyo process temperature profile of your drug product?

Here at ProJect Pharmaceutics, we can monitor temperature kinetics & distribution during lyophilization (freezing, primary & secondary drying) using our contactless infrared (IR) thermal camera system. Monitoring drying kinetics during lyophilization can support evaluation of heat transfer into vial, confirmation of product temperature in vial and optimization of the overall freeze drying process.
Using the IR thermal camera system, we can also monitor the thawing kinetics in the drug substance batch and thus i.e. detect inhomogeneous thawing behavior in the drug substance bulk container or overall duration of the thawing process.
Curious? Then check out some videos on IR camera monitoring on our YouTube channel https://www.youtube.com/watch?v=lK1fszYFjD4

ProJect Pharmaceutics’ announces extension of service offering: In-use stability studies

ProJect Pharmaceutics has extended its capabilities to conduct in-use stability studies. The current portfolio on in-use stability services was topped by the addition of several perfusor pumps, as well as the operation of a red-light laboratory (to handle light-sensitive substances). We have the necessary laboratories, technical equipment, consumables and expertise to replicate the conditions for a clinical trial so that the stability of a drug can be evaluated in real-life application scenarios. This enables us to conduct in-use stability studies for injectable drug products from as early as during formulation development to as late as ahead of clinical trials.