Identifying the optimal formulation and dose form which shows an increase more than 20 times in the oral bioavailability of Salmon Calcitonin.
As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms.
Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.
Technology transfer involves manufacturing drug product with increasing batch sizes on larger equipment or using continuous processing on pilot scale equipment.
Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.
Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.
Using workflow based software solutions to guide scientists through various processes in low to high throughput screening campaigns.
Predicting potential problems serves no purpose if it is not accompanied by adequate corrective actions or mitigation strategies to address them. This webinar will also discuss risk mitigation options for both early and late stage development programs.
Piramal Pharma Solutions (PPS) is pleased to welcome Ash Stevens LLC as a part of the Piramal Group. Leveraging five decades of Ash Stevens’s operational experience and technical expertise, Piramal’s service offering now includes High Potency API (HPAPI) development and manufacturing capabilities. Located in Riverview, USA, our state-of the-art FDA licensed cGMP facility offers a full range of scale and containment options for high potency API manufacturing.
Data-driven risk assessment enables smart decisions on development strategy.
Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd with a vast network of development and manufacturing facilities located in North America, Europe and Asia.