Optimizing Semisolid Dosage Forms

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.
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PEER-REVIEWED RESEARCH

Achieving Balance in Sterile Product Manufacturing

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
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DRUG DEVELOPMENT

Why Training Matters

Investing in worker training is crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.
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REGULATORY WATCH

GMP Challenges for Advanced Therapy Medicinal Products

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
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OUTSOURCING REVIEW

CMO Investors Have More Money Than Places to Spend It

CMO industry consolidation may be frustrated by a dearth of attractive assets.
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API SYNTHESIS & MANUFACTURING

Outlook Bright for Branded and Generic Active Ingredients

A strong API market is expected in 2016 despite fewer new drug approvals.
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TROUBLESHOOTING

Determining Biosimilarity

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes for determining biosimilarity.
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ASK THE EXPERT

Crafting Standard Operating Procedures

Susan Schniepp and Andrew Harrison, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.
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Webcasts

Optimizing M&A Integration for Customer Success: The CMO Perspective

Sponsored by AMRI
Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should be talking to the CMO.

Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

Sponsored by Patheon
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.

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.