PEER-REVIEW RESEARCH

Rethinking Limits in Cleaning Validation

An integrated approach can improve the efficiency of cleaning validation studies.
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REGULATORY WATCH

Serialization Shake Out

The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.
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OUTSOURCING REVIEW

Small-Molecule API CMOs Are Thriving

Despite emergence of biologics, small-molecule APIs benefit from industry growth.
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API SYNTHESIS & MANUFACTURING

Advances in Fluorination Chemistry for API Synthesis

Safer solid reagents and new coupling chemistry are important developments.
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PACKAGING FORUM

Parenteral Packaging Advances

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.
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TROUBLESHOOTING

Identifying Powder Properties that Define Process Performance

Dynamic properties provide insight into powder behavior, such as flow rate in feeders.
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Webcasts

Sample Preparation Technologies for Improved Peptide Quantitation Workflow

Sponsored by Thermo Fisher Scientific
Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.

Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography

Sponsored by Tosoh Bioscience
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.

Addressing Formulation Needs With a Different Technology: Say "Hello" to Ion Exchange Resins

Sponsored by Dow
Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.