Analytics

More CMOs look to proprietary delivery technologies to enhance profitability.

The presence of very low levels of residues (including solvents) in excipients is becoming an important issue for users, and the presence of very low levels of ?non-lactose? species in DPI lactose may pose challenges to suppliers and users.

Arlington, VA (Sept. 12)-At the American Association of Pharmaceutical Scientists meeting here, &quote;Real World Applications of PAT and QbD in Drug Process Development and Approval" (Sept. 11-12), chemical engineer and process modeler Michael L. Thompson, PhD, described how Procter & Gamble (West Chester, OH, www.pg.com) applies these mathematical tools to increase product quality and reduce development and trouble-shooting time for consumer and pharmaceutical products.

Washington, DC (Sept. 12)-The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

Quantitative data from the literature show strong relationships among average particle size, powder densification, tensile strength, and hardness.

A group of researchers from Georgia Institute of Technology (Atlanta, GA) are using high-throughput ionization techniques to identify and measure the ingredients in counterfeit drugs.

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.

Accurate characterization of active pharmaceutical ingredients (APIs) is a critical part of the drug development process. The approaches used to characterize APIs with respect to structure, identification of impurities, and the solid-state were discussed by Andrew C. Kolbert, manager, molecular structure and spectroscopy, Cardinal Health (Dublin, OH).

The laboratory supplier landscape is undergoing a radical makeover.

Thermal effusivity and power consumption may help predict granulation end point in high-shear granulators. In this study, power consumption was monitored and compared with percent relative standard deviation (RSD) on thermal effusivity measured at-line. Lactose monohydrate, microcrystalline cellulose, and magnesium oxide were granulated, and the effect of load size on granule growth in a fixed-volume granulator was evaluated using three load levels. Load size, liquid addition rate, and impeller speed were measured, and the correlation among RSD on effusivity, power consumption, mean granule specific surface area, and granule compressibility index were determined.

Chemir Analytical Services (Maryland Heights, MO) acquired Gateway Chemical Technology, Inc., (St. Louis, MO), a provider of custom synthesis and process development services.

On May 8, Thermo Electron Corporation (Waltham, MA) and Fisher Scientific International Inc. (Hampton, NH) announced they would merge in a tax-free, stock-for-stock exchange.

Using Bezier curves, an experimental process controller has been developed for biosynthesis applications in which the inactivity of a pH-sensitive enzyme must be decreased. By taking into account various control scenarios of pH and growth rate, as well as the physical and chemical characteristics of the environment, a suitable human-machine interface can be developed.

This article examines the development of a business case to secure coveted funding for a LIMS implementation. Information on hard cost savings and soft benefits of implementing a LIMS system, and managing the compilation of the cost justification are covered.

The evolution of sophisticated monitoring systems has been accelerated because of stringent EU legislation surrounding the pharmaceutical industry and the escalating demand for preventative maintenance techniques. This article gives an overview of the benefits of implementing these systems in pharmaceutical manufacturing.

A laboratory information management system (LIMS) can control, manage, organize and document information thus saving time and money.

This article looks at the different types of marking and coding techniques used in the pharmaceutical supply chain and their role in helping to prevent counterfeiting.

The survival of Bacillus subtilis spores in dicalcium phosphate, lactose, and corn starch and in their binary mixtures depends on the compressional properties of these materials and on parameters involved during the tableting process, including compression speed.

At Convention 2005, USP's constituents ratified resolutions to continue and expand USP's international activities.

This review article discusses orally disintegrating tablets and their manufacturing technologies, development issues, and future trends.

Performing D-value and population verification is critical in the acceptance criteria for allowing a new lot of biological indicators into a facility before acceptance and use of the lot in validation work or routine monitoring of sterilization cycles.

Guidance for reducing the risk of dissolved ozone measurement and addresses proper installation, calibration, and verification to ensure the best possible answers from dissolved ozone analysis.

Could compounds in chocolate yield new pharmaceutical approaches to major disorders?

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

Pellets are a multiparticle, solid form of medication. The individual pellets are almost spherical with diameters usually between 100 and 2000 ?m.

Creation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4

The pharmaceutical sector is a billion dollar industry with a huge responsibility towards its customers and investors. The main tools for fulfilment of this responsibility are ensurance of compliance and maintenance of control. It is a time-consuming job to uphold these responsibilities, and many important decisions regarding this subject are taken every day. It is important to make carefully considered decisions and follow them up. It is also essential to stop once in a while and reconsider their validity and relevance.

Implementing a PAT Strategy

Human 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 therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.