BioPharm International, November 2008 - BioPharm International

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BioPharm International, November 2008
Features
Global QA and Regulatory Compliance: The Business Case for an Enterprise-Wide Strategy
By Denise Queffelec , David Peterson
A centralized quality control strategy may be the best solution.
Applying Operational Excellence Concepts to Biopharmaceutical Processing. Supplemental Tables. (PDF)
By Beth H. Junker
Supplemental tables for the above-mentioned article, providing additional information about the application of operational excellence methods.
Applying Operational Excellence Concepts to Biopharmaceutical Processing
By Beth H. Junker
Translate the concepts in to practical applications and reduce waste.
Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory Perspective
By Ruth V. Cordoba-Rodriguez, PhD
FDA perspectives on specs and effective control strategies.
Columns and Departments
The Company at the Crossroads. Part 2: Build or Buy?
By James E. Bonine , Conrad J. Heilman, Jr., PhD , Siddharth J. Advant, PhD
When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.
Top 10 Legal Issues Biotech Start-Ups Must Address
By Jennifer S. Geetter , Kelli Watson Francuzenko , Judith Toffenetti
A top-10 list of critical legal issues that biotech start-ups should make an effort to address, even when the capital squeeze is intense.
Biomanufacturing Capacity Quandary
By Jim Miller
There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.
The Challenges and Benefits of Disposable Technologies
By David Radspinner, PhD
Interview with David Radspinner, director of global marketing & customer applications, bioprocess production at Thermo Fisher Scientific.
Contract Manufacturing in India: Is the CMO Model a Viable Business?
By Eric S. Langer
If Indian biologics manufacturers can establish a track record for recombinant products, enhance quality image, maintain cost competitiveness, and demonstrate technology transfer and regulatory knowhow, they are likely to be in the middle of the next boom in biologics manufacturing.
Statistical Essentials—Part 4: Regression and Design of Experiments
By Steven Walfish
Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study.
The Environmental Impact of Disposables
By Laura Bush
Despite creating plastic waste, the disposables option is better for the environment.
Nanotechnology Creates Opportunities, Challenges for Biotech Manufacturers
By Jill Wechsler
The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products.

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