Cynthia A. Challener

Transition metal-containing catalysts are widely used in organic synthesis, but many are based on expensive, rare metals. Researchers are seeking more sustainable alternatives.

The perceived risks associated with cocrystals may be slowing progress of their industrial application.

Appropriate process design and engineering are critical for the production of small-molecule and biologic HPAPIs.

Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

Once an afterthought, packaging has now become an essential component of biopharmaceutical product development and marketing.

Drug developers are taking a wait-and-see approach to the use of cocrystals.

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

Both upstream and downstream processes can benefit from continuous manufacturing advantages.

Lifecycle management opportunities are impacting the development of controlled-release technologies for solid-dosage drugs.

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.

Advanced drug delivery technologies can increase efficacy and safety, extend patent lives, and provide competitive differentiation for biopharmaceuticals.

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.

In order to ensure a safe drug supply chain, governments have implemented both legislated and voluntary programs designed to address problem areas.

Drug formulators are looking for new excipients to address solubility and bioavailability issues and extend patent protection, but there are hurdles to using novel, specialized ingredients.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

For its use of innovative technology for the production of seasonal and pandemic influenza vaccines, the Novartis Holly Springs, North Carolina facility was the Overall Winner of the 2013 Facility of the Year Award issued by the International Society for Pharmaceutical Engineering (ISPE).

Use of a continuous-flow reaction made it possible to scale up a highly exothermic reaction for the production of a key Suzuki−Miyaura coupling reagent.

Measuring headspace gas composition and pressure allows sterile product manufacturers to simultaneously monitor important quality parameters rapidly and nondestructively.

The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.

EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.

Synthesis of tetracycline derivatives with novel substituents has been challenging. Using an approach based on a Michael-Dieckmann reaction, new compounds with enhanced antibiotic properties are now being prepared on a large scale.

Pharmaceutical industry restructuring has created different strategies for drug manufacturers to consider in managing surplus laboratory and manufacturing assets.

For both small- and large-molecule applications, advances in mass spectrometry are leading to interest in this technique as an alternative to liquid chromatography.

New routes enable the efficient synthesis of enantiopure sulfinamides and structurally and sterically diverse P-chiral phosphine oxides.