Authors
Latest:
Final Word: The Public Side of Science: The Cloning Three Ring CircusIn this century, we are unlikely to face biomedical issues more complex and controversial than that of human cloning coupled with embryonic stem cell research. With the stakes so high — promises of cures and therapies for a host of devastating diseases and medical conditions set against impassioned disputes about when life begins — the cloning debate has evolved beyond the realm of scientific discourse and into the spotlight of public opinion. Unfortunately, this intense scrutiny, largely fueled by the media, has resulted in the misrepresentation of facts, and the twisting of scientific opinions as statements about cloning are often taken out of their appropriate context. In an attempt to counteract this damaging trend, The Science Advisory Board decided to poll its members about some of the most controversial aspects of the cloning debate.
Latest:
Downstream Processing: A Revalidation Study of Viral Clearance in the Purification of Monoclonal Antibody CB.Hep-1The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.
Latest:
Introduction: An Overview of Intellectual PropertyBiopharmaceutical companies need to consider intellectual property issues early on, even at the start-up stage.
Latest:
Domestic Patents - Questions You Should Ask Your Patent AttorneyYour research and development team has just shouted "Eureka!" after long and expensive years of research, exclaiming they have developed a next-generation pain reliever. What do you do next? This article explores and suggests your next steps and identifies pertinent questions to ask a patent attorney. The focus is on intellectual property; this article does not address the myriad regulatory issues that must be resolved.
Latest:
Final Word: Think Safety and Use Common Sense to Meet New IND GMP RegulationsOn January 17, 2006, the FDA released new regulations, effective June 1, 2006, which affect the production of most investigational drug and biologic products intended for phase 1 clinical trials. These regulations are much broader in scope than the Exploratory IND guidance released on the same day, and which apply only to low-risk, CDER-regulated clinical studies.
Latest:
PEGylation of Proteins: A Structural ApproachThe type of reactive moiety controls the site and stability of the covalent link and also the total number of PEGylation sites on a given protein.
Latest:
Enhanced Packaging and Reformulations Give New Life to BiologicsFormulations for pulmonary inhalation comprise spherical, porous particles that are 1–3 microns in diameter.
Latest:
Violet Diode-Assisted Photoporation and Transfection of CellsVarious methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
Latest:
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.
Latest:
Intellectual Property LitigationPatents are litigated in the biopharmaceutical industry perhaps more often than any other form of IP
Latest:
Filter Clogging Issues in Sterile FiltrationA case study investigated the root cause of failures in sterile filtration by evaluating the effects and interactions of four operating parameters.
Latest:
Chromatography Process Development Using 96-Well Microplate FormatsUsing packed columns in process development activities limits the scope for appraising a large and diverse range of media.
Latest:
Applying Continuous Improvement (CI) ManufacturingContinuous Improvement requires a sound philosophy. Is your company following the correct principles?
Latest:
Development of a Novel Platform TFF System for Insect Cell Culture HarvestThe overall average flux rate for the concentration and diafiltration step was 41 L m–2 h–1.
Latest:
Violet Diode-Assisted Photoporation and Transfection of CellsVarious methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
Latest:
The Laboratory Control System: Fulfilling cGMP RequirementsReserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.
Latest:
Best Practices in Demand and Inventory PlanningThe foundation of a sound supply chain planning infrastructure requires implementing a strong, systematic forecasting process.
Latest:
Expediting the Technical Transfer of Biopharmaceutical ProductsEstablished, fully validated methodology and SOPs are required prior to initiation of any training activities.
Latest:
The Value of a Supplier AllianceThese latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to the need to create smarter manufacturing operations
Latest:
Discovering Value in Outsourcing Facilities ManagementYour company's job is to make biopharmaceutical products. Managing facilities is a function supporting the main task. General manufacturing companies discovered this long ago, but pharmaceutical producers have been lagging. Once you consider the outsouring of non-core activities like facility management (FM), office services, space planning, and utilities management, you can focus on core business functions that make profits.
Latest:
Final Word: Collaborate to Compete?Daunting but common challenges currently face many biotech, pharmaceutical, and device firms. These companies are encountering a restless public, worried investors, and a skeptical, publicity-hungry Congress that are all concerned about product safety and the reliability of regulators' scrutiny.
Latest:
Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
Latest:
Assuring the Effective Use of Standard Operating Procedures (SOPs) In Today's WorkforceSOPs are written job aids that detail the procedure of how to do a specific job task correctly.
Latest:
Boosting Mammalian Cell-line Manufacturing Pilot Plant—A Case ReportCell-line and process development expertise, along with disposable systems, assist in implementing strategies for fast expression enhancements.
Latest:
A Systems-Based Team Approach to GMP ComplianceCompanies faced with real or threatened FDA sanctions are usually least prepared to react effectively.
Latest:
GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological ReagentDevelopment guidelines for MAbs serve as a blueprint for their manufacture, safety, and efficacy testing.
Latest:
Closing Gaps in Quality Control of Electronic DataAll potential uses and supporting endeavors of the data must be examined and then defined as a virtual process stream.
