Dr. Xiaolin Cao, Ph.D.
Raman spectroscopic technique has made tremendous progress in the
past decade with respect to its sensitivity, functionality and versatility. Its
applications in pharmaceutical industry have been expanded markedly
Jianhua Li, Jenny Lee, Murty Varanasi, Ph.D., Kang Ping Xiao, Ph.D.
Developing a robust analytical method for pharmaceutical
products is always challenging. A lot of effort has been devoted to
chromatographic separations, column selections, and quick analysis
turnaround time. On the other hand, less attention has been paid
to sample preparation and/or to the subtle differences in various
chromatographic instrumentation. Matrix effect seems to be more of a
concern in bioanalytical samples or for LC-MS studies [1].
Clare Hoskins, Woei Ping Cheng
Drug efficacy and bioavailability are largely dependent on drug physicochemical
properties such as water solubility, pKa and Log P. Today it is
widely recognized that up to 60% of new drugs in the developmental
stage are water insoluble [1] and this presents a major challenge to the
pharmaceutical industry. For drugs to be administered intravenously,
drugs formulated as aqueous-based injections are most desirable. Thus
drug aqueous solubility is a prerequisite [2]. For oral drug delivery, drugs
must be able to dissolve in the aqueous gastrointestinal fluid before
absorption can take place in the gastrointestinal tract (GIT) [3]. Therefore,
for drugs which have high permeability but with poor solubility (Class II
according to Biopharmaceutics Classification System), rate of dissolution
is a major rate limiting step for the absorption of these drugs via oral
administration. As a result, this undesirable property often leads to poor
oral bioavailability and erratic GIT absorption.
Lada Laenen, Ph.D., Ruth Daniels, Ph.D., Liesbeth Bouchet, Koenraad Swinnen
Genzyme is a global biopharmaceutical company with 7 major
approved products and serving patients in more than 100 countries.
Genzyme has substantial experience in medical, clinical and regulatory
affairs. In April 2011, Genzyme became a wholly owned company of
Sanofi, one of the world’s largest pharmaceutical companies. Sanofi’s
portfolio of products includes: prescription medicines, vaccines,
generics, consumer health care, and animal health. Genzyme is Sanofi’s
global center of excellence in rare diseases and multiple sclerosis (MS).
Genzyme’ major marketed therapeutic products: specific recombinant
enzymes for the treatment of the rare, genetic, lysosomal storage
disorders (Gaucher, Fabry, MPSI and Pompe disease), a recombinant
protein hormone for use in the management of thyroid cancer and a
recently approved oral therapy for Multiple Sclerosis (MS). Genzyme has
another late stage product for the treatment of MS and an innovative,
late stage product in the field of familial hypercholesterolemia.
Shouvik Roy, Ph.D., Christian Ruitberg, Ananth Sethuraman, Ph.D.
Lyophilization is widely used for pharmaceuticals / biopharmaceuticals
to improve stability and provide adequate shelf life. In spite of wellestablished
records of process development [1-8] scale-up/tech-transfer,
[9-16] and validation [17] of optimized lyophilization process, deviations
to the validated process still occur during commercial manufacturing.
Each process deviation requires an assessment of the impact to product
quality and stability.
Cara N. Wilder, Ph.D.,, Elizabeth Kerrigan
Microbial contamination of parenteral products is one of the most serious issues currently facing
the pharmaceutical industry. Injectable drugs, which are administered directly into the circulatory
system, bypass a number of innate human immune defenses associated with the gastrointestinal
system. Therefore, to ensure the sterility of each of these products prior to patient administration,
pharmaceutical companies must adhere to strict government regulations regarding quality
control. Maintaining and following a robust quality control program is integral to quality standards
and meeting regulatory requirements.
Kurt Nielsen
The Catalent Applied Drug Delivery Institute brings together the knowledge of the world’s leading
experts in drug development, delivery and formulation—within Catalent, the industry and academia.
This collaborative approach is designed to help bring better treatments to market by advancing the
development and adoption of applied drug delivery technologies.
Robert Mattes
Near-infrared spectroscopy (NIRS) is an analytical technique based on absorption measured in the
near-infrared region of the electromagnetic spectrum that is between the visible and the mid-infrared
regions. The fundamental absorption bands of functional groups occur in the mid-infrared and are very
strong. The overtone absorptions of these fundamental bands occur in the near-infrared (NIR) spectral
region and allow direct measurement without sample preparation due to the relative weakness of
absorption. The OH, CH, NH and SH bonds have the strongest overtone absorbance in the NIR region. [1]
Dr. Shaukat Ali, Dr. Karl Kolter
Over 60% of new chemical entities that are poorly soluble qualify either as BCS Class II or Class IV and
they provide challenges as well as opportunities to scientists working in formulation development [1].
The conventional solubilization approaches such as physical modifications of drug crystals (surface
alteration of API, micronization or micro-milling) usually lead to a limited dissolution and solubility
enhancement, but when developing a medium or high dosed formulation, the non-conventional
formulation approaches are often required particularly when dealing with almost water-insoluble
compounds usually characterized by a high melting point and/or very high lipophilicity [2].
Dawn Yang, Robert Thomas
In recent years, Raman Spectroscopy has gained a reputation in market segments that require the rapid
identification of unknown compounds, such as the testing of high purity chemicals, measurement
of pharmaceutical ingredients and the characterization of polymer materials. The reasons behind
this surge of interest, is that modern Raman instrumentation using intelligent decision-making
software and on-board spectral libraries, is an ideal technique for molecular fingerprinting purposes.
Thomas H. Chrzanowski, Ronald L. Smith
The equivalence of two test methods that detect microbiological contamination was evaluated by comparing the rate of positive and negative results obtained from identical samples. The methods were a rapid, Amplified-ATP bioluminescence (ATP+) method and the compendial plate count method. The study measured the degree to which the methods agreed when performed repeatedly on multiple lots of the same product.
Adam Goldstein, Michael Pohlscheidt, Jacqueline Loesch, Kellen Mazzarella, Boris Bieger, Philippe Lam, Joey Teshima
Recombinant DNA technology has enabled the industrial production of monoclonal antibodies and
recombinant proteins for targeted treatments of several diseases like cancer, viral infections, and so
on. Therefore, the production of biotherapeutics is of increasing importance for the pharmaceutical
industry. Recently, a large number of monoclonal antibodies and therapeutic proteins have been
approved and will be the major source of revenue for the industry in upcoming years [1-5]. The
expression system of choice for the production of complex recombinant proteins and antibodies
are mammalian cells cultivated in suspension [6-9]. Manufacturing scales up to 25 m3 operated in a
batch, fed batch or repeated batch mode are state of the art in the industry. Following the cell culture
process, a sequence of chromatography, filtration and concentration steps are performed and the
purified bulk drug substance is frozen for improved long-term stability [10, 11] - a typical antibody
production process is shown in Shukla and Thömmes 2010 [12].