Authors
Latest:
The United Kingdom: Leading the Global Competition for BiotechAs a company that performs site selection for biopharmaceutical companies worldwide, Fluor Global Location Strategies has witnessed one country truly distinguishing itself from the competition as a worldwide leader in the industry: the United Kingdom. The global competition for biotech investments has been at a fever pitch over the past few years, with varied results.
Latest:
Final Word: NIH-Biopharm Interactions and the New NIH Conflict-of-Interest Regulations. . . These new stringent rules will strongly impact the pipeline of scientific talent the NIH has provided the biopharm industry.
Latest:
Expediting the Technical Transfer of Biopharmaceutical ProductsEstablished, fully validated methodology and SOPs are required prior to initiation of any training activities.
Latest:
Final Word: Creative Solutions Can Ensure Pandemic Flu PreparednessCertain areas of the vaccine market appear to be in vogue again, revitalized by blockbusters such as Prevnar, the pneumococcal pneumonia vaccine that reaped $1.5 billion in sales last year, and the human papilloma virus vaccines, which are projected to reach $4 billion per year.
Latest:
Biowaste Management During Biopharmaceutical Plant Start-Up: From Regulatory Guidance to Verified Inactivation MethodsUntil now, there was little data on chemical inactivation of CHO cells and other GMM.
Latest:
Production of Recombinant Therapeutic Proteins in the Milk of Transgenic AnimalsCapital investments in production plants represent a significant portion of the cost of new recombinant drugs
Latest:
From Smart Tags to Brilliant Tags: Advances in Drug Stability Monitoring"Smart" tags speak only when spoken to. "Brilliant" tags are capable of independent decision-making.
Latest:
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.
Latest:
Monoclonal Antibodies for CancerCancer treatment has grown into a multibillion-dollar business responsible for saving and improving the lives of countless patients each year. One of the approaches generating a flurry of interest is monoclonal antibodies.
Latest:
The Art and Process of Successful In-LicensingUtilizing a measured approach can increase the probability for identifying search criteria that fulfill a company’s strategy.
Latest:
Part 11 Is Not Going Away: The New Electronic Records Draft Guidanceby Wolfgang Winter, Agilent Technologies GmbH and Ludwig Huber, Agilent Technologies GmbH The rules for electronic records and signatures still remain in effect. The change means that companies must now justify their decisions on whether or not to implement specific electronic controls with documented risk assessments and considerations of the record requirements detailed in the corresponding predicate rule.
Latest:
Orderly Documentation Management During StartupOne of the critical early tasks of the documentation team is coordinating plans and requirements with the start-up team.
Latest:
Project Management Services MatterProject management is a specific set of skills and processes administered to meet the specific complexities of a project.
Latest:
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.
Latest:
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
Latest:
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.
Latest:
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:
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.
Latest:
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.
Latest:
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.
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.
Latest:
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.
Latest:
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.
Latest:
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:
Prepare Your Computer System for InspectionOrganizations can mitigate the risk of failure during regulatory inspections by identifying and correcting deficiencies before an inspection occurs.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
