Cynthia A. Challener

Methods must be suitable at each development phase, robust, and effective on multiple platforms.

New practical approaches to the synthesis of complex heterocycles are reviewed.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

Defining critical parameters and processing large quantities of data can be a challenge.

Supply chain security and quality group Rx-360 driven by patient safety.

Fluorination can significantly impact the bioavailability of drug substances, however, safer fluorinating reagents and access to GMP fluorination capabilities remain challenges.

New investments, expansions, and company rebranding are discussed at CPhI.

The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.

While advances in chemocatalysis for chiral synthesis continue apace, many companies have focused attention on the development of a wider array of enzymes that can be used under commercial manufacturing conditions for the selective conversion of various substrates into more complex intermediates.

The last 12 months have seen a number of major acquisitions in the contract manufacturing space.

Safer fluorinating reagents and access to GMP fluorination capabilities remain challenges in API synthesis.

Advances in solid and liquid formulation techniques are providing more options.

Multidirectional collaboration is critical for the new pharma business model; cloud-based information services can offer a communications alternative.

With a quality-by-design approach, robust processes can help deliver quality product consistently.

A literature survey underscores the breadth of chiral chemocatalysis and interesting new techniques for the selective preparation of asymmetric compounds.

A survey of the recent literature reveals numerous advances in asymmetric chemocatalysis.

With a quality-by-design approach, robust processes consistently can help deliver quality product.

Biopharma manufacturers must reduce risk in their complex supply chains and establish effective monitoring and control systems.

Changing regulations are impacting the identification and monitoring of variable materials in excipients.

New excipients and improvements to existing excipients are needed to facilitate access to new drugs for patients.

Biopharma are looking to reduce risk, increase performance, and optimize productivity in raw material development.

Biopharma companies seeking to leverage opportunities in African market must adopt the right strategy to achieve success.

Biopharma manufacturers must reduce the risk in their complex supply chains

The pharma industry makes slow, but steady moves toward commercial-scale continuous processes for small-molecule API manufacturing.

Customers are looking to reduce risk, increase performance, and optimize productivity.

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.

The pharma industry is moving toward commercial-scale continuous processes for small-molecule API manufacturing.

The Modular Automated Sampling Technology platform allows sampling of bioreactors.

The Modular Automated Sampling Technology platform takes online samples from bioreactors and transfers them directly to analytical devices.

Industry seeks alternatives to costly and toxic precious metals used to form the catalysts for organic synthesis.