Manufacturing

Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA?s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.

Pharmaceutical companies are responding to the high cost of introducing new drugs to market in different ways.

Careful mixing during a product's distillation can help avert trouble from a strong concoction.

Researchers develop various catalytic approaches for improving yield, purity, stereoselectivity, and process conditions.

Novartis AG and Novartis Pharmaceuticals Corporation have been focusing research efforts on rare diseases since the company was established in 1996.

Pharma companies and their suppliers are tasked with managing an evermore complex clinical-trial material supply chain.

New product reviews for November 2011.

Biosimilar manufacturers need better expression systems and analytical tools to compete.

The study evaluates near-infrared analysis of tablets nominally containing 4 mg of chlorpheniramine maleate and 10 mg of phenylephrine hydrochloride per dose.

The authors describe the operational qualification of test accuracy with regard to temperature drift using a thermal-compensation algorithm on several freeze dryers.

The fifth in a series of eight case studies from the Product Quality Research Institute focuses on nonsterile facility cleaning requirements.

Russia is aiming to provide an alternative to China and India for drug manufacturing, including APIs.

The authors propose a plan to keep the US pharma industry afloat and in the lead.

The US Pharmacopeia (USP) proposes to lower the maximum permissible limits of trace elements in pharmaceuticals and recommends that impurities be measured through automated instrumentation-based methods. The proposed regulations specify inductively coupled plasma–mass spectrometry (ICP–MS) and inductively coupled plasma–optical emission spectrometry (ICP–OES) as the techniques of choice. This article discusses the benefits of ICP–MS and ICP–OES for the accurate detection of trace elements in pharmaceutical products, in compliance with the proposed USP chapters.

The authors discuss the analytical methods and related testing for bioequivalence studies of ADCs.

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

Combining olfactometry analysis with multidimensional gas chromatography–mass spectrometry provides an extremely useful analytical method for identifying aroma or odor notes from a sample.

Counterfeit medicines are an increasing threat to the EU supply chain and there is need for a standard identification solution across Europe.

A Technical Forum Moderated by Patricia Van Arnum, featuring contributions from PerkinElmer, BioTools, Chiral Technologies, Shimadzu Scientific Instruments, GE Analytical Instruments, and Waters.

This article focuses on the history of glass delamination and methods that detect it, both from a compendial and a research perspective.

The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median aerodynamic diameter, one of the metrics routinely used for comparative testing.

The authors investigate the effect of low pH and ionic strength on aggregation using turbidity measurements and size-exclusion–high-performance liquid chromatography.

The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry.