Scaling up from the lab bench to commercial manufacturing is one of the most critical steps in pharmaceutical development. It is not just about making a bigger batch but it is about proving consistency, ensuring quality, and meeting regulatory expectations. Below a simple checklist that often guides scale-up and exhibit batch execution: Pre-Scale Up: finalize…
Surfactants play a key role in improving solubility and maintaining sink conditions, but using too much can artificially speed up drug release. If you get similar dissolution results across different concentrations, it’s best to go with the lowest level that is still physiologically relevant. Reproducibility matters – choose a concentration that gives consistent results across…
One of the areas of the most focus in the dissolution world right now is the Apex vessel, which was formerly called the Peak vessel. With all of this new attention, I thought it would be good to answer some of the most common customers I get from scientists about this unique vessel. When should…
In the development of generic pharmaceutical products, aligning formulation design and regulatory strategy with prior approved data significantly improves the chances of first-time-right submissions. One highly effective method to gain such insight is through the use of biopharmaceutical review documents obtained via FOI requests. These documents, available publicly through regulatory agencies such as the USFDA…
Affinity Chromatography is one of the most powerful and precise techniques for the analysis and separation of biomolecules such as proteins, enzymes, and antibodies. Due to its high specificity and ability to isolate specific compounds from complex mixtures, it is highly popular in pharmaceutical industries, biotechnology, and biological research. Principle of Affinity Chromatography In this…
In the Bacterial Endotoxins Test (BET), incubating reaction tubes at 37°C ± 1 for exactly 60 ± 2 minutes is a key step. But why such specific conditions? Let’s dive in. 1. Optimal Enzyme Activity The heart of BET lies in the Limulus Amebocyte Lysate (LAL) reagent, sourced from horseshoe crab blood. This enzyme reacts…
In pharmaceutical formulation development, finalizing the tablet weight is not a routine or arbitrary decision. It is a strategic choice that can significantly impact bioequivalence outcomes, patient compliance, manufacturing efficiency, and regulatory acceptance. This decision is influenced by multiple factors. Here’s how development teams typically approach it: Innovator (RLD) Tablet Weight as a Benchmark The…
In pharmaceutical tablet manufacturing granule size plays a critical role in ensuring smooth processing, uniformity, flowability, and compressibility. The optimal granule size depends on multiple factors, including the tablet weight, dosage form type, API properties, and manufacturing method. While there is no strict one-size-fits-all rule, certain guidelines are generally followed based on tablet weight ranges….
