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.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.
Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls.
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 way to lower the suspension viscosity of a drug is through the use of highly-concentrated crystalline suspensions, or protein crystals.
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.
Almac has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.
A tale of two molecules, both designed to treat the same condition, both with solubility challenges. Two biopharma companies racing to be first.
This case study demonstrates how a commercial manufacturing partnership between Alkermes Contract Pharma Services (Alkermes) and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent (HP) Active Pharmaceutical Ingredients (APIs).
When a client needed to manufacture softgel capsule clinical supplies in a low cost, highly dose flexible manner, they turned to Velesco Pharmaceutical Services for MTOSoftgels.
With locations throughout the United States, Asia and Europe, AMRI has an unmatched ability to provide globally integrated solutions using flexible business models.
Pfanstiehl is the premier manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications. In addition, Pfanstiehl is a leading contract development and manufacturing organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule Active Pharmaceutical Ingredients (API), in gram to multi-ton commercial quantities. While most ingredient manufacturers or resellers focus on other industries such as food, cosmetics, agriculture, and/or nutritional supplements, offering only a subset of “pharma grade” ingredients, Pfanstiehl is Pharma Grade through and through. It’s all we do. Pfanstiehl’s ICH Q7 compliant manufacturing facility is centrally located just north of Chicago, and only 35 minutes by car from O’Hare International Airport.
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.
Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.