Osmolality describes the concentration of solute particles in a solution and is a critical parameter for the quality and performance of pharmaceutical products and cell culture media. Cells are highly sensitive to osmolality, as it influences osmotic pressure and the movement of water across cell membranes. Maintaining osmolality within an optimal range is essential for cellular homeostasis, ensuring proper cell function, viability, and overall physiological balance.

According to Ph. Eur. 2.2.35 and USP <785>, we measure osmolality using an osmometer, which determines the freezing-point depression. A small sample is gradually cooled, and the osmometer detects the temperature at which ice crystals first form. This temperature is compared to the freezing point of pure water to calculate the osmolality. A greater freezing point depression indicates a higher osmolality.

Conductivity is a key parameter in the quality control of cell culture media and pharmaceutical solutions, as it provides valuable insights into the ionic composition of a solution. Cells depend on a precise ionic balance for optimal function, making accurate conductivity measurements essential for ensuring product consistency and performance.

In our quality testing center we ensure reliable results according to Ph. Eur. 2.2.38 and USP <644> requirements. A conductivity meter is calibrated using certified control standard solutions and the electrical resistance of the solution is recorded. The obtained values are then compared with expected reference values to verify compliance with specifications.

PAN-Biotech implemented the turbidimetric kinetic method as described in the European Pharmacopoeia (Ph. Eur. 2.6.14, C and USP<85>) to detect and quantify endotoxins originating from Gram-negative bacteria.

This method measures the turbidity of a reaction mixture that forms when endotoxins interact with Limulus Amoebocyte Lysate (LAL). The increase in turbidity is directly proportional to the endotoxin concentration and is continuously monitored using a photometer over time. To determine the endotoxin level in a sample, the measured values are compared against a standard curve, and the results are assessed in relation to the specified product limits.

Mycoplasma are a unique type of bacteria that are challenging to detect due to their small size and lack of a cell wall. Their ability to pass through commercial sterilization filters makes them a persistent risk in cell culture environments. Mycoplasma contamination can lead to significant economic and scientific losses, compromising research integrity and product quality.

To ensure the highest quality standards, we perform Mycoplasma testing in accordance with European Pharmacopoeia 2.6.7 guidelines, which outline a fast and sensitive detection method. DNA is extracted from cell culture media and analyzed using polymerase chain reaction (PCR) with specific primers designed to target mycoplasma DNA sequences. This method enables rapid and reliable detection, preventing contamination before it affects cell cultures and biopharmaceutical products

The use of DNA- and RNA-based pharmaceuticals is becoming an increasingly important area of research for treating various diseases and developing vaccines. These innovative therapies and vaccines rely heavily on the purity and integrity of their nucleic acid components. Therefore, all materials and consumables involved in the production and application of these pharmaceuticals must undergo rigorous testing to confirm the absence of DNases and RNases. PAN-Biotech has implemented and validated a state-of-the-art fluorometric method specifically designed to detect DNases and RNases.

Sterility is a critical quality attribute for pharmaceutical products, cell culture media, and other biotechnological solutions to prevent microbial contamination and ensure product safety and reliability. Bacteria, fungi, and other microorganisms can thrive in nutrient-rich environments, posing risks to cell cultures, therapeutic applications, and research integrity.

At PAN-Biotech GmbH, we perform sterility testing in accordance with Ph. Eur. 2.6.1 by inoculating test samples into suitable culture media and monitoring for microbial growth. This testing process ensures that tested products meet the highest sterility standards, supporting safe and contamination-free applications in biotechnology, pharmaceuticals, and life sciences.

PAN-Biotech implemented Raman spectroscopy as a non-destructive analytical technique to confirm the identity of materials by measuring the vibrational modes of molecules. This method is highly effective for identity testing of raw materials, pharmaceutical products and cell culture media, as it provides a unique molecular fingerprint for each substance. The Raman spectrum generated serves as a reference, allowing for the identification of specific compounds based on their characteristic peaks.

Density is a key property of liquids, influencing their suitability for various applications. At PAN-Biotech, we validated the oscillating U-tube method, which accurately measures liquid density by detecting the frequency of oscillation, which correlates with the sample’s density. The density measurements provide valuable insight into the composition and quality, ensuring that each product meets the required specifications for optimal performance.

For the analysis of key biochemical parameters, colorimetric assays are employed to quantify total protein, glucose, and hemoglobin levels. These components are essential for maintaining a well-balanced nutrient composition, supporting optimal cellular function and metabolic activity in culture systems.

Since lipids play a crucial role in cell metabolism and membrane integrity, the concentrations of triglycerides and cholesterol are analysed using validated enzymatic methods. Accurate quantification of these lipids is necessary to ensure that the serum provides appropriate lipid content for cell growth while avoiding excess levels that could interfere with cellular processes.

Capillary electrophoresis is utilized for the quantitative analysis of various serum proteins, including albumin, alpha-1 globulin, alpha-2 globulin, beta-1 globulin, beta-2 globulin, and gamma globulin. This technique allows for precise separation and measurement of these proteins, providing valuable insights into the serum’s composition and quality.

To enable the detection of lower concentrations of gamma globulins (IgG), PAN-Biotech implemented a direct sandwich ELISA. This highly specific and sensitive assay enhances the accuracy of gamma globulin quantification, ensuring a comprehensive assessment of immunoglobulin levels within the serum.

To confirm the absence of tetracycline, a highly sensitive immunoassay is performed. This test ensures that the serum is free from tetracycline contamination, making it suitable for use in Tet-inducible systems, where the presence of even trace amounts of the antibiotic could interfere with gene expression regulation.