Manufacturers Face Key Policy and Regulatory Challenges

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Lessons Learned from FDA Inspections of Foreign API Facilities

A study of recent inspection observations allows for baseline trending and continuous improvement.
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FORMULATION

A Matter of Taste

Experts spoke to Pharmaceutical Technology Europe about the different approaches used in taste-masking and the challenges involved.
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EXCIPIENTS

Excipient Selection for Protein Stabilization

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.
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FACILITY DESIGN

Getting Flexible with Manufacturing

The industry is moving towards more flexible manufacturing with the use of modular facilities and single-use systems.
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Generating Savings from Room Declassification

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.
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API SYNTHESIS & MANUFACTURING

Going Low Temperature

More complex drug candidates require more specialized and selective chemistry.
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OUTSOURCING REVIEW

CMOs Concerned With Cost of Single-Use Equipment

Suppliers indicate prices for single-use equipment are likely to increase.
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TROUBLESHOOTING

Cleaning a Vial Filling Line

Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile pharmaceutical manufacturing process, including vial filling; operators share best practices for cleaning.
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ASK THE EXPERT

Computerized Systems Validation

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
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Webcasts

Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs

Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and offers high production capacity in a small footprint. Learn how to improve the solubility of poorly water-soluble active ingredient using twin-screw wet granulation and proper excipients.
Sponsored by BASF

Controlling Contamination in Biopharmaceutical Manufacturing

In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.
Sponsored by SGS Life Science Services

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

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.
Sponsored by Tosoh Bioscience