Pharma Blog
Why Protein Folding Matters?
Proteins are tiny machines that must fold into the right shape to work. Imagine folding a piece of paper into a paper airplane. If the folds are done right, you get a perfect flying airplane. One wrong fold? It doesn’t fly—it falls apart. That’s exactly how proteins behave. Why Is ... Read More
DNA Extraction Process
DNA extraction is more than just a lab technique; it’s a process rooted in biochemistry and molecular biology principles. 1. DNA extraction A process of isolating DNA from cells or tissues to study its structure, sequence, or function. This process involves breaking open cells, separating DNA from other cellular components, ... Read More
What Makes a Protein Functional?
Proteins are not just strings of amino acids they are complex, highly structured, dynamic molecule that must fold correctly to function properly. But what exactly determines whether a protein is functional? Here are some factors that determine proteins functionality: Primary Structure Protein Folding Post-Translational Modifications (PTMs) Molecular Interactions Environmental factors ... Read More
Conducting BE Studies for NTI Drugs
Here’s a detailed explanation of how bioequivalence (BE) studies are conducted for narrow therapeutic index (NTI) drugs, including regulatory expectations, study design, analytical methods, and statistical analysis: Detailed Overview: Bioequivalence Study for NTI Drugs What are NTI Drugs? NTI (Narrow Therapeutic Index) drugs are those where small differences in dose ... Read More
DCP vs. MRP | Choosing the Right Regulatory Pathway in the EU
Navigating the European regulatory landscape can be complex, especially when seeking approval for medicinal products across multiple countries. Two key procedures streamline this process: Decentralized Procedure (DCP) and Mutual Recognition Procedure (MRP). While both facilitate multi-country approvals, understanding their differences is essential for strategic regulatory planning. Decentralized Procedure (DCP) DCP ... Read More
Handling Conflicting Regulatory Requirements | A Strategic Approach
In global regulatory affairs, one of the most complex challenges we face is resolving conflicting requirements from different regulatory bodies. Each agency has its own set of expectations, shaped by regional regulations, scientific perspectives, and risk tolerance. Navigating these differences requires a strategic, risk-based approach to ensure compliance while maintaining ... Read More
The Secrets of Good Peak Shape in HPLC
Achieving good peak shape in HPLC is essential for accurate quantitation, improved resolution, and extended column lifetime. A well-shaped peak is symmetrical, with a tailing factor of ~1.0, high efficiency, and narrow peak width. Key Factors Influencing Peak Shape Column Selection & Chemistry Silica Purity & Acidity: Specialized Phases: Mobile ... Read More
Ways to Extend the Lifespan of C18 Columns & Guard Columns
Use a Guard Column Filter and Degas Mobile Phase Use Proper pH and Buffer Conditions Regular Column Flushing Avoid Prolonged Exposure to Aqueous Buffers Inject Clean Samples Optimize Flow Rate and Pressure General Precautions Before Cleaning Initial Rinse (Removing Buffer and Salts) Purpose: To remove any buffer salts that may ... Read More
Fumigation in Pharmaceutical Industry
Fumigation is an important process in maintaining sterile conditions in pharmaceutical manufacturing areas. Here’s an overview of fumigation in sterile areas within the pharmaceutical industry: Purpose of Fumigation Common Fumigants Fumigation Process Steps Preparation: Sealing the Area: Application: Exposure Time: Ventilation: Safety Considerations Regulatory Compliance Documentation and Validation Read also: ... Read More
Seamless Technology Transfer in Topical Products
Technology transfer (TT) is crucial for ensuring product consistency, compliance, and scalability in topical formulations (creams, gels, ointments). A structured TT minimizes risks in scale-up, process validation, and site transfers. R&D to Manufacturing Transfer Site-to-Site Transfer Successful TT requires QbD-driven process control, cross-functional collaboration, and regulatory alignment to ensure smooth ... Read More
Clean-in-Place in pharmaceutical Industry
CIP, or Clean-in-Place, is a critical process in the pharmaceutical industry, ensuring that equipment and systems are effectively cleaned without disassembly. Importance of CIP in Pharmaceuticals Key Components of CIP Systems Steps in a CIP Process Read also: Resource Person: Omar Salah