Manufacturing

A new FDA policy emphasizes quality control over GMP compliance in producing clinical trial supplies.

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.

Secondary sensors help protect feedback control systems from the effects of sensor drift.

GSK Gains Approval for Rotavirus Vaccine in Infants; FDA Review Extended for Merck’s Shingles Vaccine

The PAT guidance indicates a variety of risk-based approaches to managing the introduction of on-line analysers into existing processes with the aim of minimizing the regulatory burden for the manufacturer and encouraging innovation.

Clean rooms are areas in which it is essential that microorganisms are not allowed to proliferate because they could contaminate pharmaceuticals and directly affect human health.

Pharma companies are forming alliances with less established biotech companies, which significantly drive the technological innovation and the overall market growth.

FDA Recommends Changes for 2006-2007 Flu Vaccine

Baxter Wins Contract to Develop Cell-Based H5N1 Vaccine

Applikon Biotechnology

Cambrex (East Rutherford, NJ) to produce Geron (Menlo Park, CA) telomerase anti-cancer vaccine. Generex (Toronto, ON.) files IND for synthetic vaccine to stimulate cell-mediated immunity to avian influenza. Dow Agrosciences (Indianapolis, IN) wins USDA approval for veterinary vaccine, the first manufactured via plant cell culture. G-8 nations pledge billons for vaccine production.

The Pharmaceutical Industry has been slow in adopting radio frequency technology (RFID) to help control diversion and counterfeiting, according to a recent study by ABI Research (Oyster Bay, NY, www.abiresearch.com). In fact, only 10 drug products are expected to be shipped with RFID tags or smart chips embedded in the labeling in the coming year.

Merck wins approval for rotavirus vaccine as Sanofi ships investigational H5N1 vaccine to NIH and CDC explores new flue diagnostics and novel vaccine-production technology.

Dow AgroSciences Receives Regulatory Approval for Plant-Made Vaccine

The pharmaceutical industry's focus on process understanding, monitoring, and control is driving manufacturers to take greater steps toward identifying possible manufacturing bottlenecks earlier in the development process. For tablet, capsule, and excipient producers, such efforts include taking a closer look at the flow-ability of their powders.

Enterprise information integration delivers needed real-time capability to operational business intelligence.

FDA is proposing revisions to the drug user fee program while it weighs changes for drug safety initiatives and expanded vaccine production.

Cell-Grown Vaccine Protects Against Avian Flu Virus

Using a novel automated microfilling system, the authors demonstrate that roller compaction followed by milling is a viable preprocessing technique for high-dose chemical-in-capsule dosage forms. The process results in higher bulk and tapped densities for drug substances compared with milling alone.

The regulating authorities have, it seems, a preference for the application of multimembrane combinations to maximize organism retentions.

There are over 250 operations in the EU in various stages of development involving tissue engineering, regeneration and subsequent attempts at commercialization.

The type of robot used for placing and stacking the BFS cards is important. Conventional multi-axes designs have limited flexibility, often combined with high inertia that limits operating speeds.

Though dissolution testing has been under scrutiny, it is still a powerful test method.

This article discusses the advantages and disadvantages of using solid-state NMR spectroscopy for the analysis of pharmaceutical solids.

Pfizer Combats Counterfeiters with RFID

Sanofi Pasteur and BD Team Up to Produce Microneedle Vaccines

There is a rapidly growing ageing population that requires sophisticated medical devices and newer drugs. This is likely to result in an increase in the use of robotics to improve manufacturing efficiency. This article looks at the role of SCARA robots in pharmaceutical plants and laboratories.

The medical industry was the first to understand the benefits of using disposable devices, such as needles and syringes, to prevent risks of cross contamination. The technology was then extended to blood transfusion activities, and it was only 10–15 years ago that the biopharmaceutical industry started to use disposables. Initially, most of the applications were limited to storage, involving bags, tubing and filter capsules. Since then, significant progress has been made in the polymer and plastics industry; in particular, a number of organic polymers have been developed that are resistant to gamma irradiation, autoclaving and even sterilization-in-place, rendering the technology attractive and usable by the biopharmaceutical industry. Now, the industry is moving beyond storage-focused disposable technologies to more complex processing applications.

FDA has tightened up the approval of new drugs, ensuring careful scrutiny of clinical data and stringent scanning to analyse the probable side-effects of a new drug

The closed vial has been developed to improve aseptic filling quality and to reduce process complexity. A ready-to-fill closed vial consists of a sterile vial provided with the stopper secured in place. The vial is filled by inserting a non-coring needle through the stopper, which is then resealed by laser.