Latest Developments and Insights

Cell and gene therapy development has entered a transformative era, bringing unprecedented challenges and opportunities in Chemistry, Manufacturing, and Controls (CMC). As these revolutionary treatments progress from clinical trials to commercial manufacturing, the future of CMC in cell gene therapy…

Sujata Kulkarni Why did you choose a career in biopharma? Growing up, I didn’t have the option to pursue medicine due to various reasons, so I had to select a field that aligned with my interests. This is when my…

Stability studies are essential to pharmaceutical development, providing the data needed to make sure drugs remain safe and effective throughout their shelf life. These studies evaluate how environmental factors like temperature, humidity, and light impact a drug’s quality over time.…

The biopharmaceutical industry stands at a pivotal intersection of regulatory evolution and technological advancement. Companies that successfully adapt to these changes while maintaining robust compliance frameworks will be best positioned to deliver innovative therapies to patients safely and efficiently.  …

A strong CMC strategy is crucial for biotech startups moving into clinical trials. Regulatory agencies expect detailed documentation to confirm a drug’s safety, consistency, and quality, which means early planning can prevent costly delays. Startups that take a proactive approach…

The pharmaceutical landscape has evolved dramatically since the first synthetic drugs were developed over a century ago, highlighting the ongoing debate of biologics and small molecules. Today, healthcare providers can choose between traditional small-molecule drugs and sophisticated biological therapies, each…