Mike Auerbach
Has the COVID-19 vaccine become our Holy Grail?
Tim Sandle, PhD
Rapid microbiological methods continue to advance, with novel technologies appearing on the marketplace albeit more orientated towards general research or to the food quality sector rather than conventional pharmaceutical applications. This article, in acknowledging that pharmaceuticals continue to move forwards, examines some recent advances, drawing on technologies that have not been specifically developed for pharmaceuticals, but which have the potential to be applied in the future.
Dr. Chris Moreton, Ph.D.
The ‘Rule of Five’ (Ro5) is clearly aimed at medicinal chemists. However, in the past 25 years we have seen an increase in the number of poorly water-soluble drug candidates, to the extent that as many as 70 – 80% of small molecule drug candidates may be classified as poorly water-soluble today. This paper will review Ro5 from a formulation scientist’s perspective, and discuss methods used in the formulation of poorly water-soluble drugs as immediate release oral solid dosage forms.
Frits Stulp
The coronavirus response highlighted the need for global data standards in medicine, giving renewed impetus to work on IDMP (Identification of Medicinal Products) standards. Frits Stulp of Iperion Life Sciences Consultancy looks forward to this year’s progress with IDMP in Europe.
In a post-translational modification reaction called glycosylation, living organisms attach carbohydrate residues known as glycans to their proteins. The resulting glycoproteins fulfill numerous functions, including as structural components of cell membranes and mediating cell interactions. Some hormones (e.g., thyrotropin, hCG) and components of the immune system (immunoglobulins, interferons) are also glycoproteins.
Compliance with Good Manufacturing Practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorization. Likewise, the manufacture of investigational medicinal products must be in accordance with GMP. Advanced therapy medicinal products that are administered to patients under Article 3(7) of Directive 2001/83/EC1 (so called “hospital exemption”) must be manufactured under equivalent quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorization.
Ronald A. Rader, Eric S. Langer
Cell culture media and its development have been one of the most vital parameters influencing the performance and facilitating adoption of perfusion bioprocesses.
Going “Green” in today’s business climate where maximizing shareholder equity and conserving capital is a top priority can be difficult, especially if the project increases the overall cost of doing business.
Viral vaccines contain either inactivated or attenuated viruses with the aim of inducing a protective immune response in the recipients against the respective infectious disease. The induction of this immune memory is made up of two parts; antibodies which bind to an invading virus and prevent proliferation and also the cellular immune memory which has multiple pathways to prevent and eliminate viral infection.
Jeanne Moldenhauer
The last two decades started a change in how microbiological methods are being performed, using rapid microbiological methods (RMMs) and alternative microbiological methods. In many places, microbiological identification systems are treated separately from RMMs. Since the completion of the human microbiome project, a need for new tools has been identified for identifying the specific organisms and traits in the various biome applications. While researchers are evaluating the microbiome for various parts of the body, e.g., blood, urinary tract, gut, reproductive tracts, and the like the need for new tools is frequently reported.
Operating through six production sites, IMA Life (Aseptic Processing & Freeze Drying Solutions) is one of the three pharmaceutical divisions of the IMA Group, world leader in the design and manufacture of automatic machines, highly specialized in the production of complete aseptic lines from the initial washing of the bottles, through depyrogenation, filling, capping, decontamination, up to and including secondary packaging.
Jim Polarine, Richard Chai, Harry Kochat, PhD, Paul Jeffry Pulliam, Kaining Zhi, PhD, Kiara Brooks
One of the key quality attributes for evaluating effectiveness of the cleaning and disinfection program is the in-situ validation. The requirement can be accomplished by performing expansive environmental monitoring in the area after a triple clean is conducted. The triple cleaning process does not have a standalone standardized definition in the industry yet. The closest definition of the triple cleaning process reported so far is to use the disinfectant two times followed by the sporicide. There are other processes utilized in the industry for bringing the facility online after a worst-case event such as Vaporized Hydrogen Peroxide® (VHP) bio-decontamination application, fogging application, or a 9X cleaning.
Sample size approaches for container closure integrity testing (CCIT) for routine commercial biopharmaceutical production vary across the industry. Currently, there is no official standard or published procedure to follow for sampling approaches or defining appropriate sample sizes.
Vineet R. Kulkarni, B. Pharm, MS, Anqi Lu, BS, MS, Mohammed Maniruzzaman, PhD, SRPharmS, MAS
Recently, the three-dimensional (3D) printing (3DP) process, often referred to as ‘additive manufacturing’, has gained significant attention across many disciplines. It creates physical objects by successive deposition or addition of material based on a geometrical representation.1 The advent of 3DP and the application of this technology in the pharmaceutical sector has led to a paradigm shift in the way we approach treatment options for patients.
Jennifer Hu, Hai Yue, Timothy G. Johnstone, Christopher Clouser, Taylor Zhang
T cells play important roles in adaptive immunity by serving as sentinels against foreign pathogens. T cells that have been engineered to recognize cancer-specific antigens present a promising treatment option for a number of hematological cancers and solid tumors.
Sydney Jannetta
One of the most meticulous assays in a quality control laboratory is the bacterial endotoxins test. With patient lives at risk, the criticality of the test is tremendous. One failure can result in costly retests, out-of-specification (OOS) investigations, and even substantial recalls.
Neelam Sharma, M.S., Hemant N. Joshi, Ph.D., MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the U.S. Patent Office in September-October 2020.