Mike Auerbach
In general terms, the word Luddite was originally coined to describe someone who is against the march of technology and its effects on the working force.
Cell culture medium plays a crucial role in industrial biopharmaceutical processes since it provides essential nutrients and the proper environment for high viable cell density and efficient therapeutic protein expression. Besides growth and productivity, other media performance aspects should be considered, such as product quality and medium powder manufacturability. In the past few decades, industrial cell culture media have evolved from formulations containing animal-derived or plant-derived components to chemically defined (CD) formulations to reduce potential for adventitious agent introduction and to reduce raw material variability. This review focuses on media development for Chinese Hamster Ovary (CHO) cell cultures, including a brief history of mammalian cell culture medium, general media development strategies and considerations, as well as some more recent progress in CHO media development.
Chiara Celli, Fabrizio Lecce, Flavio Peroglio
Pyrogens comprise a heterogeneous group of fever inducing compounds derived from microorganisms and non-microbial substances. This kind of contamination is considered a serious public health issue and can result in symptoms ranging from vascular alterations to shock and death.
American Pharmaceutical asked our readers several questions regarding the technologies and processes they use, and the issues they face, when developing oral solid dosage (OSD) products. The results of our survey are below and provide an insight into the challenges manufacturers face when bringing new OSD products to market.
R.P. “Kris” Iyer, PhD
More than 300 million patients worldwide are infected with hepatitis B virus (HBV). Each year, more than a million of these patients die from the virus, which is also major cause of liver cancer and cirrhosis. Worldwide, cancer claims the lives of millions more. Chronic HBV, cancer, and a variety of inflammatory diseases are caused by immune dysfunction at the cellular level. Now, the power of nucleic acid technology is being harnessed to design small molecule nucleic acid hybrid (SMNH) drugs that harness the patient’s own immune system to defeat these cancers and cure viral diseases at global scales.
Dr. Duncan Stacey
Many pharmaceutical materials are developed in solid form for practical reasons, such as
storage and transportation and ease of administration. However, for them to be effectively
absorbed by the body, they must be soluble in an aqueous environment.
We meet formulators’ needs by providing an unparalleled range of excipients and technologies, as well as longstanding polymer expertise and technical support for oral solids. our knowledge of the structure function of polymers, combined with our extensive product line of tablet binders, film coatings, disintegrants, and drug solubilizers can help bind, coat, dissolve, and effectively deliver complex drug molecules where and when they’re needed.
Tom Buchanan, Dr. Sara Carillo, Jonathan Bones, PhD
Thanks to their high target specificity and long half-life in humans, therapeutic monoclonal antibodies (mAbs) have grown steadily in use to become the leading biotherapeutic product class. Over the past three decades, more than 80 mAbs have received regulatory approval for the treatment of a broad range of diseases, including inflammatory, autoimmune and cardiovascular conditions as well as cancer. The therapeutic impact of mAbs is set to further increase, with the market expected to grow by almost 7% annually to reach an estimated US$174 billion by 2026.
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.
Christopher W. Lester, J. Timothy Ramsey, Jonathon S. Salsbury
Lipid-based drug products present complications for bacterial endotoxins testing because the Limulus-based detection system functions only in an aqueous environment. By taking advantage of the amphipathic nature of lipopolysaccharides, an oil-water extraction process may be used to separate endotoxins from oily drug formulations. This article presents the results of an endotoxin spiking study that demonstrates the effectiveness of this method, with consideration of the testing parameters that can affect endotoxin recovery.
As the pharmaceutical industry continues to strive toward modernization, meeting regulatory expectations, and preserving patient safety, organizations are seeing the benefits of intra-industry collaboration and sharing of best practices.
Dr. Johannes Kiefer
Co-crystallization is commonly applied in the formulation of pharmaceutical products. Coformer screening, process monitoring, and product analysis before, during, and after the production of cocrystals however is not straightforward. This article aims at shedding light at the analytical capabilities offered by optical spectroscopic techniques with a focus on absorption and scattering methods across a wide spectral range.
The number of programs receiving accelerated review are on the rise, helping to get therapies to patients sooner, but developers and manufacturers need to prepare to move quickly through clinical trials.
Most people are aware of the requirements of the code of federal regulations 21 CFR Part 11 for computer software security, which have been a major pharmaceutical IT focus for approximately 10 years.
T. McCoy, R. Affleck, D. Khamar
Lyophilization (Freeze Drying) is a drug product manufacturing unit operation, used to stabilize active pharmaceutical ingredients such as proteins, many of which are unstable in the liquid state. It is the most commonly used method of stabilization of pharmaceutical drug products and has been the traditional approach for many years (Tang and Pikal 2004). Lyophilization is a process by which a liquid formulation, usually filled into a container such as a type 1 glass vial, undergoes a series of controlled temperature and vacuum steps, by cooling/heating a shelf with heat transfer fluid or controlling vacuum pressure by using a vacuum pump and nitrogen.
Gregg Schorner, Xiangrui Li, Aditya Tulsyan, Tony Wang, Myra Coufal
The use of Raman spectroscopy in cell culture bioprocesses can provide in-situ analysis of critical process parameters when partnered with chemometric modeling. Traditionally, each parameter to be analyzed is individually modeled, with each model being calibrated to specific regions of the Raman spectra. SIMCA [Umetrics; Malmo, Sweden] is a software commonly used in biomanufacturing for calibrating and deploying chemometric Raman models. The chemometric model building process is time consuming and follows the same steps.
Commercial manufacturing of biologics such as monoclonal antibodies (mAbs) and recombinant proteins requires robust, reliable processes which cost-efficiently deliver high yields of a safe and effective product.
Pharmaceutical laboratories ultimately want to make sure their products are safe. They need to ensure the quality of the media they are using for testing, monitor laboratory equipment and obtain good samples.
Any variant in our line of confocal Raman microscopes can be used in pharmaceutical research.
Sunny Christian, MS, 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 US Patent Office in September-October 2019.