Axel Becker, Anna Petereit, Ph.D., Christoph Saal, Ph.D.
Understanding the biopharmaceutical properties of drug substances has become crucial for different phases of pharmaceutical research and development. One of the major goals during research phases such as lead optimization is to design molecules to allow sufficient absorption of the drug. Therefore, medicinal chemists usually choose an iterative approach to improve drug properties such as solubility, lipophilicity and permeability while maintaining and also improving properties such as potency, selectivity, metabolism and toxicology.
Sulaf Assi, Ph.D.
The objective of this work is to compare handheld to laboratory-based Raman instruments for the identification of counterfeit medicines obtained from the world market. More than 200 tablets of proprietary and generic pharmaceutical products were obtained worldwide. Handheld Raman spectroscopy offered many advantages with respect to cost, rapidity, mobility, operation in wide temperature ranges, on-spot identification of materials and ease of use by non-skilled personnel. However, there were still many drawbacks associated with the use of handheld Raman instruments related to spectral quality, fluorescence and Raman activity. However, this did not affect the accuracy of identification.
Donald C. Singer
Development of pharmaceutical formulations incorporates a complexity of collaborative knowledge from ongoing partnering of scientists, integrated to ensure that quality attributes of a formulation lead to efficacy, purity and patient safety.
Anne Kavanagh, Ph.D., Ian McConvey, Ph.D., Jim McCabe, Ph.D., Helen Blade, Ph.D., Steve Cosgrove, Ph.D.
Amorphous pharmaceuticals represent both opportunity and necessity in pharmaceutical development. The opportunity arises from the potential to improve bioavailability via use of an amorphous form, rather than a crystalline form. On the other hand, it is sometimes the case that no crystalline form is available, in which case it is necessary to deal with the amorphous form. This article will discuss the development of amorphous pharmaceuticals, with reference to three case studies from within AstraZeneca.
Omar L. Sprockel, Ph.D., Douglas Both
Product development using Quality-by-Design principles, as expressed in ICH Q8 (R2), has yielded a wealth of information at the interface between material science and process science. Using this knowledge to implement process controls in commercial production will ensure consistent product quality.
Luis Jimenez, Narendra Rana, Octavio Santiago, Joseph Amalraj, Kimberly Walker
Contamination by Gram-negative bacteria is one of the major reasons for sterile products recalls in the United States [1]. Endotoxins are major structural components in the cell wall of Gram-negative bacteria [2]. If present in injectable biopharmaceuticals, they can trigger reactions leading to extreme morbidity, i.e., fever, or mortality [2, 3]. Some of the potential sources of endotoxin contamination are water, excipients such as solvents, thickening agents, chelating agents, antioxidants, reducing agents, preservatives, buffers, bulking agents, and special additives [2].
Nigel Smart, Ph.D.
After 30 years manufacturing biologicals from recombinant DNA processes, the biotechnology industry is now at a point where commodity principles associated with manufacturing are starting to play an important role. There are several reasons for this and some of the key drivers include the following:
Yeung Chan, Ph.D., Olav Lyngberg, Ph.D.
Purifying early drug candidates by preparative chromatography has become routine practice by drug discovery scientist in recent years. Driven by the desire to shorten development timelines, use of preparative chromatography in pharmaceutical development for kilogram quantity supplies has also become more prevalent.
For over a century, lactose has been one of the most widely used diluents or binders in solid dosage form manufacturing. For the past couple decades, lactose has become an important ingredient in dry powder inhalation drug delivery. Most recently, lactose has found its way into parenterals, where it acts as a drug stabilizer and prevents proteins from denaturing.
Some of this may be common knowledge to your readers, but it is worth reiterating. There is a need for rapid microbiological testing in pharmaceutical manufacturing. Businesses continue to test using methods that were developed more than a century ago. You can understand why the method is so prevalent. It works, and it is a low cost. But, there are drawbacks, one of which is time.
1.In your particular realm of biologics manufacturing services, what are your biggest challenges in general and how are you working to overcome these challenges?
The industry trends we are seeing ask for flexible and cost-effective manufacturing facilities and processes.