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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|FORMULATION|

Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations

This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
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Characterization and Formulation Screening of mAb and ADCs by High-Throughput DLS

High-throughput dynamic light scattering effectively screens for optimal ADC formulations by investigating the effects of buffer conditions and temperature on aggregation.
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|QUALITY|

Leveraging Change for Continuous Process Improvement

Managing change and overcoming employee resistance and fear requires a proactive approach.
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|PROCESS CONTROL|

Connecting MES to Process Control

Using ISA-88 batch architecture standards can simplify communication between manufacturing execution and process control systems to improve the efficiency of such human activities as sampling and electronic batch recordkeeping.
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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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|OUTSOURCING OUTLOOK|

Small-Molecule API CMOs Are Thriving

Despite emergence of biologics, small-molecule APIs benefit from industry growth.
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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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|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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|ASK THE EXPERT|

Investigating Biologics

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.
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|VIEWPOINT|

Evolving to Meet Industry Changes

In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.
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|Webcasts|

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.

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.