Nisana Andersen, Lisa Vampola, Rashmi Jain, Melissa Alvarez, Scott Chamberlain, Amy Hilderbrand
Inherent to protein biosynthesis, including the synthesis of therapeutic monoclonal antibodies (mAbs), are heterogeneous protein products.
Such heterogeneities include post-translational modifications (PTMs), misincorporations, and mistranslations. mAbs are also susceptible
to chemical degradation throughout production, purification, formulation, transportation, storage, and use. To ensure product quality and safety, pharmaceutical regulatory authorities require
extensive characterization of physiochemical and biological properties of manufactured drug substances and drug products during pharmaceutical development
Katherine Bergmann, PhD
Viral contamination events have occurred in a number of production processes over the last
20 years. In most cases, the source was either proven or suspected to be a raw material component.
Most of the contamination events have occurred with non-enveloped viruses, which lack an outer lipid envelope.
James Bruno
If you entered a modern factory, it would look a lot like a factory of the 20th century. In fact, the basic design of a stirred tank reactor has changed little over the last one hundred years. Today, things are really starting to change. In the future, manufacturing trains may look more like a Rube Goldberg device that the factory of the 20th century.
Beth DiPaolo, MA, SPHR
It’s no secret that during the past decade or so, the Bio/Pharmaceutical industry has been challenged
to balance market demands and revenue fluctuations with fixed drug development costs, whereby
fiscally staying a step ahead can be daunting due to a myriad of scenarios. Facing ever present patent
cliff headwinds, major drug companies around the world continue to grapple with increasing generic
competition, resulting in rapid revenue loss and inefficient utilization of manufacturing capacity.
Factor in the healthcare flux as more health insurance payers—in an effort to control their own costs, as well as cover the most effective treatments—may favor covering less expensive generics while placing performance metrics on medications, thereby potentially impacting what is prescribed and/or patient drug choice.
Charles Ducker, PhD, Michelle Kolodziejski, MS, Mai Jacques, PhD, Jennifer Roark, Andrew Blakinger, Thomas Lehman, PhD
The screening of the final packaging components of human drug products for extractables and
leachables has become commonplace in the 15 years since the FDA released their Container
Closure Systems for Packaging Human Drugs and Biologics.
Gary Romberger, Mihn Do, David Lavrich, PhD, Kim Gallagher, Brian Kozlowski, Erin Hein
Content uniformity testing of solid dosage forms is a critical test in almost all aspects of the drug development process. In both early- and late-phase development, uniformity testing meets a regulatory
requirement for clinical release as directed by agencies globally. In scale-up efforts and design of experiment (DOE) tests in formulation
development, it aids in the understanding of the effects of variation of parameters involved in solid dose formulation, including excipient compositions, blend rates, drying times, and tablet compression forces.
As an increasing number of variables are examined in such testing, the
number of individual dosage form units which need to be examined
in chemical assays can become considerably large. Additionally, the
manpower and reagents needed to carry out this testing become
resource intensive as the amount of testing expands.
Rajesh K. Gupta, PhD
The microbiological quality of drugs and biologics is necessary for their efficacy and patient safety, because microbial contamination of drugs causes immediate adverse effects on patient health in terms of morbidity and mortality,as well as long-term adverse effects, such as cancer, autoimmune, and other diseases.
Melanie Hofmann, Matthias Winzer, Christian Weber, Henning Gieseler
HCF are frequently required for subcutaneous or intramuscular administration. Subcutaneous administration, for instance, is a well-established approach for the application of therapeutic proteins in autoimmune and inflammatory diseases, since self-administration at home improves compliance for chronic disease. For this reason, HCF has become more and more important for novel therapeutic approaches in those therapeutic areas.
This fall, Eurofins Lancaster Laboratories is expanding its current cell banking capabilities by doubling the number of cell banking clean-room suites from two to four, by adding long-term cell banking storage for both production and non-production cell banks, by increasing the
maximum bank size from 400 to >1000 vials, and by offering insect cell bank production and testing services.
Jon S. Kauffman, PhD
As the pipeline of biologics continues to grow, biopharmaceutical organizations are outsourcing
an increasing number of stability studies. Careful consideration must be given when choosing a
partner for these programs due to their inherent complexity. Several key points to consider, including
capability, capacity, protocol development, and project management, are discussed here.
Ralph Lipp, Ph.D.
Early work on transdermal drug delivery (TDD) goes back to the 1960s, and in 1971 the seminal US Patent titled “Bandage for Administering
Drugs” was granted to ALZA Corporation. Since then, significant investments into research and development of TDD have resulted in a strong increase in scientific output, with more than 1000 scientific articles and book chapters on this topic in the calendar year 2013 alone. Today, transdermal medicines, like the fentanyl patch and others, provide
significant patient benefits. Correspondingly, the global market for TDD is attractive and growing. It generated revenues of approximately $25 bn in 2013 and is expected to exceed $40 bn by 2018.
Weihong Wang, PhD
Potency determination refers to the quantitative measurement of the biological activity of a
given product. Biological activity is a critical quality attribute; therefore, potency testing is an
essential component of quality control. Various procedures, including animal-based assays,
ligand and receptor binding assays, cell culture-based assays, or other biochemical assays (such as enzymatic assays), may be used for potency testing based on the mechanism of action of
the product. This article provides a review of the more commonly adopted assays—specifically ligand and receptor binding and cell-based potency assays, as well as recent advancements in statistical analysis for potency determination and strategies for phase appropriate method development and validation.
Anna Luczak, PhD, Ravi Kalyanaraman, Ph.D.
This article focuses on the capability of portable and benchtop Raman spectrometers for the conformation of authenticity of pharmaceutical products, including the detection of counterfeit products. Counterfeiting is an ongoing global problem for the pharmaceutical
industry.
Rodolfo J. Romañach, PhD, Eduardo Hernández Torres, Andres Roman Ospino, Isamar Pastrana Otero, Fabiola M. Semidei Ortiz
The implementation of the PAT Guidance as A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality
Assurance requires thorough process understanding of pharmaceutical processes.
Tim Sandle, PhD
A review of warning letters U.S. Food and Drug Administration indicates that contamination events associated with Bacillus species represents
a relatively high proportion of microbiological related citations. During the period March 2013 to August 2014, warning letters relating to contamination from spore-forming bacteria were issued.