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.
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
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”.
In an effort to accelerate innovation, streamline the R&D process, satisfy healthcare expectations and improve the rate of return, pharmaceutical companies have come to embrace external collaborations and their outsourcing partners as an essential part of their discovery programs. This trend towards externalization is significant with roughly 90% of companies outsourcing some steps of drug discovery, and with half of all drugs now resulting from such partnerships. This white paper, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.
Today’s mAb competition focuses on unmet therapeutic needs and biological mechanisms that have not yet been explored. As a result of this evolution, the purification of biologics is becoming increasingly challenging. This article discusses Lonza’s XS™ expression platform, which addresses the need for next-generation expression systems.
Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years, next-generation biologics have complex designs. If you are first in class or you have a very bespoke up- and downstream process, it also means you will have bigger hurdles to overcome when it comes to regulatory support and filing. At Lonza, these challenges are addressed with the GS™ expression platform.
One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.
Seahorse Bioscience provides analytical instruments, biomanufacturing systems, and consumable labware products for biological research and drug discovery. Seahorse technology is used to advance understanding of the role of cell metabolism in neurodegeneration, aging, cancer, cardiovascular, cell physiology, toxicology and hepatobiology, immunology, infectious diseases, mitochondrial diseases, model organisms, obesity, diabetes, metabolic disorders, screening, and translational medicine.
Many different public and private organizations from across the globe are collaborating on neglected diseases drug-discovery and development projects with the aim of identifying a cure for tropical infectious diseases.
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.
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.
Metabolon, Inc. has advanced the field of metabolomics by pioneering and patenting the industry’s leading biochemical biomarker discovery and profiling platform. It has developed the technology to quickly identify and measure all of the biochemicals in a biological sample through its proprietary global processing method.
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.
