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Project Management Services MatterProject management is a specific set of skills and processes administered to meet the specific complexities of a project.
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NASA's Cell Culture Unit Brings Space Station Research Down to EarthA profusion of present-day bioreactor and fermentor systems offers remarkably diverse capabilities, ranging from microfluidics to bulk production vats, simple petri dishes to complex artificial organ cultivators, and suspension, adhesion, perfusion, and many other culture management methods. Each of these systems is well suited to address specific research problems, but few are widely adaptable to diverse experiment demands - such as those conducted in space.
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Green Plants as Biofactories for DrugsGreen plants and production systems that are most removed from conventional commercial food and feed crops are most likely to succeed
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Increasing Plant Efficiency Through CIPUnfortunately, once circuits are commissioned and validated, optimizing - or even adjusting - them is difficult and rarely done because of the time and effort required for revalidation.
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Affinity Chormatography Removes EndotoxinsProtein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
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Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFPHuman plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin, and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of new therapeutic products have recently been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring, and Octagam from Octapharma.
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Strategies for Extending the Life of PatentsPharmaceutical companies today are faced with increased costs for drug discovery and development and aggressive competition from generic drug companies. As research costs skyrocket, generic drug companies sit poised and ready to compete as soon as a patent expires.
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Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFPHuman plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin, and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of new therapeutic products have recently been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring, and Octagam from Octapharma.
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Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) AreasThe complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.
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NASA's Cell Culture Unit Brings Space Station Research Down to EarthA profusion of present-day bioreactor and fermentor systems offers remarkably diverse capabilities, ranging from microfluidics to bulk production vats, simple petri dishes to complex artificial organ cultivators, and suspension, adhesion, perfusion, and many other culture management methods. Each of these systems is well suited to address specific research problems, but few are widely adaptable to diverse experiment demands - such as those conducted in space.
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Conceptualizing, Making, and Selling the BrandIn the increasingly competitive world of drug discovery and development, the role of branding is more important than ever. With all the various sectors - big pharma, generics, specialty pharma, and biotechnology -vying for limited dollars, branding must begin early in the development process and, ultimately, play an integral role not only in taking a product to market, but also in sustaining that product against competition, perceived and real.
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Affinity Chormatography Removes EndotoxinsProtein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
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Prepare Your Computer System for InspectionOrganizations can mitigate the risk of failure during regulatory inspections by identifying and correcting deficiencies before an inspection occurs.
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Final Word: World Firsts — From the Double Helix to Therapeutic CloningThe US will, beyond doubt, remain the world leader in life sciences for the foreseeable future. However, as with other sectors, bioscience - both R&D and business - is increasingly global. For US researchers and business leaders alike, it makes increasing sense to look beyond the shores of America for both expertise and profit-making opportunities. For many, the principal partner of choice has been - and will remain - the United Kingdom. There are sound reasons for this.
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Conducting the Audit - Ready or Not, Here They ComeWhen an FDA inspection is imminent, it pays to have a plan. Start by getting your paper in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And don?t forget to take notes.
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IDT Biologika and Exothera Partner on Viral Vaccines ManufacturingUnder a collaboration, IDT Biologika and Exothera will conduct feasibility studies on scaling up the manufacturing process for viral vector-based vaccines.
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Pleated Membrane Filters Improve Process EconomicsThe drive to develop better, faster, and smaller - in other words, more efficient - products is a universal trend in the modern world. This trend has profoundly impacted many industries from microelectronics to packaging equipment. In the biopharmaceutical industry, the need to speed and simplify the long and complex drug manufacturing processes brings additional challenges, such as meeting regulatory requirements.
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Making Site-specific PEGylation WorkThere are challenges aplenty in purification and analysis of PEGylated protein pharmaceuticals. Here are a variety of technical solutions, many concentrating on the chemistry of the linker.
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Filtration Designs Remove Processing Bottlenecks for High-Yield Biotech DrugsBiotech companies are running into production bottlenecks because standard purification and separation technologies lack the capability to remove the elevated levels of biomass from high titer solutions. Recent developments in filter technology offer the biotech industry a cost-effective solution to processing challenges by reducing bottlenecks, thereby accelerating the time-to-market of new drugs.
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Managing the Global Supply ChainRecent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.
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Green Plants as Biofactories for DrugsGreen plants and production systems that are most removed from conventional commercial food and feed crops are most likely to succeed
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Affinity Chormatography Removes EndotoxinsProtein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
Latest:
Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) AreasThe complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.
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Overseas Outsourcing: The Advantages of IT OffshoringLife sciences firms haven't exactly been jumping on the offshore outsourcing bandwagon. But faced with unprecedented cost constraints, competitive pressures, and regulatory scrutiny, the industry needs new solutions to its business problems. Some experts think information technology (IT) "offshoring" offers a solid alternative; others question the idea.
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Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and FiltrationCreation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes - chromatography and filtration.
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Affinity Chormatography Removes EndotoxinsProtein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
