BioPharm International, February 2006

Featured Article

Near-Infrared Analysis of Critical Parameters in Lyophilized Materials

By Jeffrey Hirsch

Lyophilized, or freeze-dried, materials are challenging samples for quality assurance and quality control (QA/QC) measurement because of the inability to open the container without corrupting the product. Near-infrared analysis presents itself as the QC method of choice for lyophilized materials due to its ability to penetrate glass or plastic containers to analyze the sample in a non-destructive manner. This study demonstrates the performance of a Fourier transform near-infrared (FT-NIR) spectrometer used in analyzing lyophilized samples of thrombin, a topical coagulant commonly used in the medical and dental fields. Key stability parameters for lyophilized thrombin include moisture and potency, which can be predicted simultaneously from a single spectrum using multivariate analysis.

Articles

GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological Reagent

By Biunayki Reyes , Rodolfo Valdés , Cristina García , Tatiana Alvarez , Ma del Rosario Alemán , Andrés Tamayo , Sigifredo A Padilla , José A Montero , Gisela Cálas , Marcos González , Maria del Carmen Abrahantes-Pérez

Development guidelines for MAbs serve as a blueprint for their manufacture, safety, and efficacy testing.

Equipment Cleaning Validation Within a Multi-Product Manufacturing Facility

By José A. Morales Sánchez

Before designing cleaning procedures, it's vital to know all physical and chemical characteristics of the product ingredients.

Columns and Departments

Legal Forum: Responding to the Avian Flu Threat: Balancing Risks and Rewards

By Michael J. Shuster

Human infections with avian flu strain H5N1 are occurring in a number of southeast Asian countries that have experienced large outbreaks of avian influenza. How great a risk to the human population is posed by this virus, and what steps can be taken to minimize its impact? Preventive vaccines have great potential to avert the spread of avian flu and other infectious diseases. What are the factors affecting the creation of new vaccines, and how can they be optimized to promote public health?

StreetTalk: Will Venture Capital Firms Turn Their Backs on Stem-Cell Research?

By Brian O'Connell

Like a snowball rolling down Mt. Everest, stem- cell research was gaining momentum, not only in political and medical arenas, but on Wall Street, too.

Outsourcing: DSM Redefines its Biomanufacturing Strategy

By Jim Miller

Moving aggressively to implement its Vision 2010 strategy, which debuted in October 2005, DSM N.V. (Heerlen, Netherlands) announced in December 2005 that it would shut down its Montreal biomanufacturing facility in early 2006. The move doesn't signal an exit from manufacturing, however, but a change in focus; DSM will simultaneously expand its expression-technology relationship with Crucell (Leiden, the Netherlands). Both moves reflect changing circumstances in the biomanufacturing sector.

Final Word: Statisticians Tackle More Than Clinical Trials

By Steven Walfish

Statisticians partner with technical experts to design statistically valid studies to construct the appropriate analysis.

Regulatory Beat: FDA Moves to Renew User Fees and Promote Preparedness

By Jill Wechsler

The Food and Drug Administration's Prescription Drug User Fee program (PDUFA) has to be reauthorized by Oct. 1, 2007, and all the interested parties are fine-tuning their wish lists for "improvements." Although some consumer advocates and their Congres-sional allies blast user fees for extending industry control over the drug approval process, FDA officials, pharma companies, and patient disease groups applaud the program's success in ending "drug lag" and speeding new drugs and biotech therapies to market.

From the Editor in Chief: Collective and Individual Progress

By Laura Bush

At a recent scientific conference, a group gathered around a table to compare experiences. Participants, in turn, asked their colleagues how to avoid problem X or how to resolve challenge Y. In most cases, those responding said, "I have found method Z to work, but not all the time." In other words, it depends. Hearing about others' approaches is helpful, but each problem still must be solved individually.