The development process for biosimilars involves an extensive testing period in order to establish similarity to the reference biologic. To ensure that the drug doesn’t have unwanted side effects, there is a broad regulatory framework developers o...
Active Pharmaceutical Ingredients (APIs) are the backbone of pharmaceutical formulations, serving as the primary component responsible for the therapeutic effects of medications. However, many APIs are sensitive to environmental factors such as...
Before it even comes to vaccine manufacturing, the vaccine must first be developed. The obstacles are manifold and the fragility of supply chains or requirements in cold chain management are just two of the challenges in vaccine development. Al...
Drug substance vs. drug product: the difference might not be clear for people that are not trained in the fields of life sciences, chemistry or pharmaceutical sciences. While the term “drug substance” is limited to the active pharmaceutical ing...
The filtration and filling of drug substances, if not done correctly, can cause severe problems. If the production steps in drug substance management from compounding to filling, labeling and dispensing of a drug substance leaves space for cont...
While one of the main goals of bulk drug substance management is to ensure quality control, safety during manufacturing, storage and transportation are of great importance. Nevertheless, the safe handling of bulk drug substances is a necessary ...
Thawing drug substances or active pharmaceutical ingredients as they are also known is a routine biotech process in practically every drug product manufacturing campaign. Freezing and thawing biologics are considered necessary process steps to ...
During the manufacturing process, delivery, or long term storage, freezing drug substance is a necessary step to ensure product quality. However, various process parameters in freezing/thawing methods are related to overall product quality. One...
In recent years, if not decades, gene therapies have proven to be key drivers of growth in the pharmaceutical industry. Production is often complex, challenging manufacturers with new hurdles: The fragile nature of medical drug products has fo...
Frozen storage and shipping of drug substances is indispensable in the biopharma industry. Nevertheless, drug substances are precious and sensitive, not only requiring careful handling but also reliable protection throughout the entire logistic...
