Manufacturing

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.

Although patient compliance problems have been receiving attention for at least a decade, many medications are still dispensed in bottles that contain a supply intended to last days or weeks and require considerable effort on the part of the patient or caregiver to keep track of the dosing schedule. As a result, when it comes to consistently taking the right dose at the right time for the duration of a prescription, many consumers don't do a very good job.

Two scenarios demonstrate the need to use the percent of parent drug loss rather than the percent of degradation products formed when reconciling mass balance calculations.

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

Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.

One of the world leaders in the manufacture of tablet compression tooling, I Holland, is offering a range of machines for the automatic polishing of tablet compression tooling.

In-process methods are key components of quality control in a chemical manufacturing plant. These methods ensure that a production reaction step conducted by trained operators within the entire validated process will produce a quality chemical entity in the expected yields. The presence of impurities and related compounds (derived from the reaction or secondary reactions) is a critical parameter that determines a synthetic material's quality.

Adding Braille to pharmaceutical packaging should be less of a challenge with the use of Esko-Graphics' Scope solution. EC Directive 2004/27/CE requires Braille labelling and information to be provided with pharmaceutical products for human use, and companies are scrambling to implement this by 31 October.

Picking may occur when granulation becomes imbedded on a punch surface and does not freely release when the compressing event has finished.

Dust extraction and centralized vacuum cleaning systems vary in their design, performance and costs. Different companies have different approaches to their design, however, there are some basic rules that must be followed if these systems are going to be immediately effective and avoid future problems.

The global pharmaceutical industry is currently in a state of flux according to Frost & Sullivan.

A CMO in Singapore manufacturing commercial biopharmaceuticals is the result of a partnership between two biopharmaceutical companies.

FDA Places All Andrx ANDAs on Hold

Biogen to Cut Jobs

Draxis Resumes Production

Sun Pharma Buys US, Hungarian Drug Plants from Valeant

Warning Letter: Similasan

A fleet of pharmaceutical manufacturers have green lighted new bar coding and e-pedigree pilots using electronic barcodes. But is Industry ready for full-scale RFID?

Cephalon partners with hardware and software providers to test item-level tagging.

Rapidly increasing cell-culture yields have thrown an increasing burden on downstream processes just as price pressures are pushing process developers to look for economies in every purification protocol. The time-honored, effective, and expensive war-horse, Protein A, is beginning to feel some competition from small-molecule mimetics.

Pharmaceutical science and technology innovation

Genecor Wins Vaccine-Development Contract

FDA Calls Chiron Facility Acceptable; GSK Gets Green Light For Flu Vaccine

Because disposable systems offer benefits that can impact the time for development as well as for the cost of production, the biotech sector is expected to continue to use these technologies ...

This article provides an overview of the important factors associated with air handling systems within pharmaceutical and biopharmaceutical facilities. It provides information on the need for these systems, design considerations and advice on the approach to commissioning and qualification.

Planning manufacturing capacity in the pharmaceutical industry is not for the faint-hearted. How can process designers help their clients to overcome some of the problems they face when planning to introduce new capacity? This article sets out to explain some of the techniques that are being employed in the early stages of project development.

Bavarian Nordic Sues Acambis for Patent Infringement

Acambis and Bavarian Nordic Vie for Smallpox Vaccine Contract

GSK Releases Flu Vaccine Production Strategies