Latest Developments and Insights

  Developing biologics can be challenging. Their development protocols are significantly different from small molecule drugs, which provide a general response and comprise as much as 90% of the pharmaceutical drug market. Biologics are more complex, though, with targeted mechanisms…

Large molecule drug products produce highly effective medicines, but formulation can be challenging because of their complexity, sensitivity, and potential for instability. It is crucial that formulation strategies ensure their bioavailability and efficacy to develop new and successful products.

  By: Deb Quick, Ph.D. Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to prevent…

  By Maria Wik, MS VP, CMC Development The ICH Q10 definition for a Control Strategy is: “A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.” Understanding the essence of…

Biomedical startups experience a failure rate of 90% per year for various reasons, including flawed financial strategies, inexperienced management, subpar science, poor timing, and an aversion to risk. Another significant factor is quality control issues stemming from poor team selection…

Personalized medicine is truly that. Based on an individual’s unique genetic profile, it’s used to make precise decisions according to that person’s biologically predetermined factors, and guides the optimum approach to disease prevention, diagnosis, and treatment. It determines the most…