Christine E. Farrance, PhD, Sunhee Hong, PhD
Bacterial Identification in the biopharmaceutical industry, especially in manufacturing facilities, is very important because an occurrence of a problematic microorganism in the final product could be harmful for the end user and detrimental to a company’s finances and reputation. Environmental Monitoring (EM) programs are the cornerstone of understanding the microbial ecology in a manufacturing facility and have become a regulatory requirement for most manufacturers. The EM program is a biological surveillance system which enables companies to quickly identify organisms which are transient or resident in their facilities before these organisms have an opportunity to contaminate a product. A properly executed EM program provides an early warning of potential contamination problems due to equipment failure, inadequate cleaning, or deficiencies in staff hygiene training, for example, so that problems can be corrected to prevent adulteration of the end product. The Food and Drug Administration (FDA) has publi
Kevin Williams
Excipients are integral components of solid oral dosage formulations
(SODF). Therapeutic efficacies of these dosages are dependent upon
the excipients’ function and method of use, and also their interactions
with active ingredients (APIs).
Kevin Williams
Recent conferences have demonstrated the polarizing nature of the Low Endotoxin Recovery debate, including those in Berlin (PDA Europe), Iselin, NJ (PMF Bacterial Endotoxin Summit), and Bethesda, MD (PDA Global Micro).
Cara N. Wilder, Ph.D.,, Yvonne Reid, PhD
Mycoplasma contamination constitutes a serious concern for cell culturists as these bacterial strains are a common cause of cell line contamination affecting roughly 15-35% of cell cultures and endangering almost all aspects of cell physiology.
Kathryn Martin Remington, PhD, Robert Kelly, PhD, John Zehmer, PhD
A key component of the viral safety strategy for a biopharmaceutical
is an evaluation of the viral clearance potential of the manufacturing
process. Certain steps of the process can provide inactivation or
removal of a potential viral contaminant, and some steps are wholly
dedicated to viral inactivation or removal. Low pH incubation is
included in a manufacturing process to provide inactivation of
enveloped viruses, and the virus reduction filtration step serves to
provide removal of viruses larger than the nominal filter pore size.
James F. Cooper
Endotoxins in gram negative bacteria (GNB) are remarkably complex
biomolecules that share a common architecture. Endotoxin is
only found in the outer layer of GNB. It exists as vesicles containing
lipopolysaccharide (LPS) molecules embedded in surface proteins,
lipoproteins and phospholipids. Lipopolysaccharide (LPS) is the
biologically active component in endotoxin, but in its pure form,
does not exist in nature. Should endotoxin gain access to body
tissues, it induces dose-dependent biological effects from mild to
life-threatening conditions.
Peter R. Griffiths
Molecular vibrations undergoing a transition from the ground state to
the first excited state absorb radiation in the mid-infrared region of
the spectrum, which extends from a wavelength of 2.5 µm (4000 cm-1)
to 25 µm (400 cm-1).
Marko Salo
The pharmaceutical industry is by definition highly innovative. New
therapies are constantly being developed that treat diseases via novel
mechanisms of action. Not surprisingly, though, innovation has lagged
somewhat when it comes to drug manufacturing. The production
of biologic and small-molecule medicines involves highly complex,
multi-step processes, and ensuring the safety of every formulated drug
product that is delivered to a patient is a top priority for pharmaceutical
companies and regulatory agencies. New technologies must be
carefully and extensively evaluated to confirm that they do not have
a negative impact on drug performance (safety and efficacy).
Limin Zhang, John Fiske, Hui Zhao, Harshad Patel, Scott Jennings
A fixed-dose combination (FDC) drug product is a formulation of
two or more active ingredients combined in a single dosage form in
certain fixed doses.
Nigel Walker
Excipients, once considered as far less important than the active
pharmaceutical ingredient (API) in formulated medicines, today are
receiving significantly more attention from both manufacturers and
regulators. Many excipient technologies are no longer considered as
simply inactive ingredients.
Dr. Xiaolin Cao, Ph.D., Zai-qing Wen, Ph.D., Tony Wang, Dave Meriage, Lise Ann Craig, Katie Parks, Cenk Undey
Raman spectroscopy has taken large strides in recent years as more Raman vendors have developed handheld Raman units capable
of carrying out raw material identification or verification.
Sven Stegemann, Sudershan Vishwanath, Ravi Kumar, Dominique Cade, Missy Lowery, Keith Hutchison, Michael Morgen, Chang Lee, Aaron Goodwin
Rapid and consistent in-vivo drug dissolution is critical for drug
absorption. In-vitro dissolution tests are used to predict in-vivo
disintegration and dissolution properties of drug products. The in-vitro
disintegration and dissolution times of tablets and capsules can vary
significantly based on their composition and processing.