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BioPharm International-11-01-2008
BioPharm International
Biomanufacturing Capacity Quandary
November 01, 2008
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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.
Applying Operational Excellence Concepts to Biopharmaceutical Processing
November 01, 2008
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Translate the concepts in to practical applications and reduce waste.
Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory Perspective
November 01, 2008
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FDA perspectives on specs and effective control strategies.
Contract Manufacturing in India: Is the CMO Model a Viable Business?
November 01, 2008
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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.
Nanotechnology Creates Opportunities, Challenges for Biotech Manufacturers
November 01, 2008
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The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products.
The Environmental Impact of Disposables
November 01, 2008
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Despite creating plastic waste, the disposables option is better for the environment.
Top 10 Legal Issues Biotech Start-Ups Must Address
November 01, 2008
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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.
The Challenges and Benefits of Disposable Technologies
November 01, 2008
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Interview with David Radspinner, director of global marketing & customer applications, bioprocess production at Thermo Fisher Scientific.
Statistical Essentials—Part 4: Regression and Design of Experiments
November 01, 2008
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Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study.
Applying Operational Excellence Concepts to Biopharmaceutical Processing. Supplemental Tables. (PDF)
November 01, 2008
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Supplemental tables for the above-mentioned article, providing additional information about the application of operational excellence methods.
The Company at the Crossroads. Part 2: Build or Buy?
November 01, 2008
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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.