Displaying 1–25 of 37 results for Angelo De Palma, Ph.D., Contributing Editor

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Materials Tracking: It's All in the Data

(Article)

Drugmakers are using MES and ERP more effectively and harnessing the power of new data acquisition tools.

Surviving Adverse Events (of the Corporate Kind)

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The waning of the Blockbuster Era has brought massive restructuring, challenging drug makers to foster innovation, teamwork and morale. Merck serves as an example of what can be done.

Vaccine Manufacturing Reborn

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Innovation is shortening time to market, reducing capacity requirements and improving yields

Tech Transfer: Don't Fumble the Hand Off

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Technology transfer was once taken for granted as something that would “get done anyway.” Now it’s an indicator of manufacturing excellence and a core competency for drug innovators.

Drug Delivery: The "Great Equalizer"

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Critical to improving performance and extending patent life, drug delivery is the only area where the small often trump megapharmas.

QbD Takes Biopharma by Storm

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Quality by Design has lost its buzzword status as it becomes a reality for more biopharma companies. Contributing Editor Angelo De Palma, Ph.D., examines how Wyeth, Schering and other companies are advancing the concept, and interviews FDA’s Moheb Nasr for his perspective.

When Less is Much, Much More

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Microreactors are challenging the concept of "economies of scale."

Transgenics: A Glimpse into Bioprocessing’s Future

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Transgenics offers significant process advantages both upstream and down, but few companies are willing to take on biotech’s entrenched culture.

Process Optimization Reality Checks

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What works in the lab may not always work after scaleup, says contributing editor Angelo De Palma.

Controlled Release Moves Beyond Patent Extension

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Prized for benefits that include reduced toxicity, controlled release — and the “manufacturability” issues it raises — is being considered much earlier in drug development process.

Green Processing

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After a long struggle, chemical manufacturers have recognized the economic value of green chemistry. Now, pharmaceutical manufacturers are following their lead, guided by the U.S. Environmental Protection Agency’s principles of green chemistry. In the process, they’re achieving significant ...

Drug Development Through the Looking Glass

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Contract manufacturers and intermediates suppliers are raising the bar for chiral chemistry in pharmaceutical development.

A Wave, Suspended: Follow-on Biologics

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FDA has yet to issue guidance on biosimilars, but scientific advances promise to aid regulators and enable “quality by design.”

A New Vaccine Supply Strategy

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Not one solution, but a combination of new technologies and simple approaches will be needed to prepare for the onslaught of flu and other diseases.

Cost-Driven Chromatography

(Article)

Pharmaceutical processing & engineering: Economics is driving bioseparations that minimize waste and maximize output, and moving continuous chromatography into some small-molecule niches.

All Aboard the Cold Chain

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Pharmaceutical processing & engineering: As liability risks increase, drug manufacturers are assuming greater ownership of the “cold chain” for transporting valuable biologics.

Tuning in to New Solvents

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Tunable solvents, including supercritical fluids and ionic liquids, may not be in your stockroom — yet — but they offer significant environmental and manufacturing benefits.

Ending the Paper Chase

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Electronic notebooks (ELNs) have become a fixture of drug discovery laboratories in the pharmaceutical industry, improving search capabilities, simplifying report generation, enhancing intellectual property protection and facilitating collaboration.

Liquid Mixing: Solid Challenges

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Pharmaceutical processing & engineering: Liquid mixing and blending would seem to be among the most straightforward of pharmaceutical manufacturing unit operations. Mechanical process mixers have been on the market for more than 100 years, and not much separates mixers for drug making from those ...

Powder Blending From Art to Science

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Dry powder blending may be the most widely recognized unit operation in pharmaceutical manufacturing, but it’s also one of the least understood. The uniqueness of each individual drug formulation assures that no two blending processes can ever be identical.

Fermentation and Cell Culture: Get it Right

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Fermentation & Cell Culture: Careful planning and design are key. Small and midsize bioreactors and disposables offer flexibility.

Handling Highly Active Ingredients

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Material handling: The latest containment systems and disposables are reducing compliance costs.

Pharmacogenomics and the Brave New World of Personalized Medicine

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FDA’s recent guidance on pharmacogenomics reduces manufacturers’ risks in evaluating genomic data. Will it spur development of more targeted therapies?

Personalized Medicine: Next Big Hope or Next Big Hype?

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Oncology drugs are driving the marketplace closer to the vision of personalized medicine, but major infrastructure change is still needed.

Downstream Bioprocessing: More is More

(Article)

Pharmaceutical processing & engineering: What's good for upstream processes -- higher concentration levels for MAbs and proteins -- can strain downstream operations, forcing manufacturers to rethink the purification train.

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