process development
Tag details
Welcome to the 'process development' tag page at Technorati. This page features content from the farthest reaches of the Blogosphere that authors have "tagged" with 'process development'.
Latest blogosphere posts tagged “process development”
-
Rapid Process Development for High Yield Plasmid DNA Fed-batch Fermentation
Pharmainfo.net —
Authority: 165
To commercialize DNA medicines, industrial plasmid DNA manufacturing processes that meet the quality, economy, and scale requirements projected for future products are needed. We have developed cell bank and fermentation process unit operation innovations that reduce plasmid-mediated metabolic burden, enabling ...1 day ago -
To FIT or Not to FIT, That is the Question
Pharmainfo.net —
Authority: 165
Throughout the industry, there are questions regarding when to integrity test filters in the purification and buffer preparation areas. This includes liquid filters as well as vent and air filters. The requirement to warrant a filter integrity test (FIT) is based on compliance with the validated claim of microbial ...1 day ago -
Quality by Design for Biotechnology Products—Part 1
Pharmainfo.net —
Authority: 165
The International Conference on Harmonization ( ICH ) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, involves some nuances and complexities. Advertisement: Author(s): ...1 day ago -
Advancing Chiral Chemistry in API Synthesis
Pharmainfo.net —
Authority: 165
Researchers at the Graduate School of Engineering at Nagoya University in Nagoya, Japan, recently reported that they developed an asymmetric catalyst that assembles spontaneously, a development that lays the groundwork for further designing functional supramolecular catalysts. Their work involved using chiral organic ...1 day ago -
Moisture-Activated Dry Granulation—Part I: A Guide to Excipient and Equipment Selection and Formulation Development
Pharmainfo.net —
Authority: 165
In the pharmaceutical industry, the three most common granulation processes for solid dosage form production are wet granulation, dry granulation (i.e., roller compaction), and direct blending. In spite of their popularity, each of the processes raise concerns as they are currently practiced. Advertisement: ...1 day ago -
A Robust, Automated Karl Fischer Titration System
Pharmainfo.net —
Authority: 165
Karl Fischer titration is one of the few assay techniques recognized by the US Food and Drug Administration for the determination of residual moisture in lyophilized pharmaceutical products (1). Because the iodine–water reaction is specific and quantitative, this technique provides high accuracy and precision. ...1 day ago -
Sharing Supply-Chain Security
Pharmainfo.net —
Authority: 165
Van Trieste is vice-president of quality at Amgen (Thousand Oaks, CA) and interim director of Rx-360, the recently established international pharmaceutical supply-chain consortium. Advertisement: Author(s): Angie Drakulich Journal: ...1 day ago -
Whatever Happened to Classical Chemistry?
Pharmainfo.net —
Authority: 165
The contributions of classical chemistry to biotechnology are sometimes forgotten, and its advances are less recognized than those of recombinant DNA technology for the production of therapeutic proteins. The hard work of thousands of scientists and researchers in the solution chemistry of proteins has quietly ...1 day ago -
Position Paper: Are We Abandoning IQ and OQ?
Pharmainfo.net —
Authority: 165
It has been quite apparent to some of us in the pharmaceutical and medical-device industries that there appears to have been a directed effort over the past number of years to eliminate the concept of and need for the installation qualification (IQ) and the operational qualification (OQ). Advertisement: ...1 day ago -
Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives
Pharmainfo.net —
Authority: 165
The National Institute for Pharmaceutical Technology and Education (NIPTE) was formed in June 2007 as an independent nonprofit organization by 11 major US universities. Advertisement: Author(s): Angie Drakulich Journal: ...5 days ago -
Building a Framework for Quality by Design
Pharmainfo.net —
Authority: 165
Driven by greater global competition and the growing impact of information technology, the pharmaceutical industry faces a need to improve its performance. Speed to market, product quality, regulatory compliance, cost reduction, waste, and cycle time are among the concerns that must be addressed in a systematic, ...5 days ago -
Question-Based Review: An FDA Reviewers Perspective
Pharmainfo.net —
Authority: 165
The Office of Generic Drugs (OGD) fully implemented Question-based Review (QbR) in 2007 with the broad goal of encouraging sponsors to include quality-by-design (QbD) principles in their product and process development and to communicate this knowledge in their submissions. Advertisement: Author(s): ...5 days ago -
Biotech Remains Updeat During the Summer
Pharmainfo.net —
Authority: 165
Traditionally, the summer months tend to be quiet for the biotech sector. However, the general markets experienced three solid months of gains as investors started to believe that the worst of the economic woes were over. Advertisement: Author(s): G. STEVEN BURRILL ...1 week ago -
Apply the "Butterfly Effect" to Streamline Your Supply Chain
Pharmainfo.net —
Authority: 165
A butterfly flapping its wings over Brazil can influence the direction and severity of a storm in New England. Called the "butterfly effect," mathematic models have shown that even very small changes in one area of a system can create large variations downstream. Advertisement: Author(s): ...1 week ago -
FDA Leaders Stress Science and Compliance
Pharmainfo.net —
Authority: 165
The new leadership at the US Food and Drug Administration is wasting little time in taking steps to make the agency more efficient and effective. The FDA is announcing new rules and policies almost daily and strengthening enforcement of manufacturing and marketing requirements to show the industry it means business. ...1 week ago -
Harvesting the Benefits of LEAN in Biopharmaceutical Manufacturing
Pharmainfo.net —
Authority: 165
The LEAN manufacturing and management model, developed from the Toyota Production System (TPS), has triggered major transformations in various manufacturing industries. Implementation in the field of biopharmaceuticals, however, has been limited to date. Advertisement: Author(s): ...1 week ago -
Biopharmaceuticals: Approval Trends in 2008
Pharmainfo.net —
Authority: 165
Advertisement: Author(s): GARY WALSH, PHD Journal: BioPharm International, October 2009 Copyright: © Advanstar Communications, Inc.. ...1 week ago -
A Closer Look at Automated In-Line Dilution
Pharmainfo.net —
Authority: 165
Automated in-line dilution is an increasingly popular technology in the biopharmaceutical industry. In-line dilution is a process that can help solve capacity, financial, and quality concerns that biopharmaceutical manufacturing plants may be facing regarding process solution preparation and delivery. Advertisement: ...1 week ago -
Spectroscopy Ramps Up as the Year Winds Down
Pharmainfo.net —
Authority: 165
t has been said that time seems to move faster the older you get, and judging by how quickly we have reached the end of 2009, I would say this cliché is certainly valid. Advertisement: Author(s): David Walsh Journal: ...1 week ago -
Discrimination of Complex Substances with Laser-Induced Breakdown Spectroscopy
Pharmainfo.net —
Authority: 165
Laser-induced breakdown spectroscopy (LIBS) analysis begins with a focused laser beam that ablates the specimen (sample), generating a small spark. The light, optical emission from the spark, which contains spectral information about the composition of the sample, is collected by an optical system. These spectral data ...1 week ago
