PROCESS CONTROL

Gaining Insight from Process Control Data

Integrated data and cloud-based solutions can be used for process optimization.
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SUPPLY CHAIN

Redefining Pharma Agility

Supply-chain success is measured by how effectively new medications reach patients, and how swiftly manufacturers can react to internal and external changes.
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PEER-REVIEWED RESEARCH

Statistical Tools to Aid in the Assessment of Critical Process Parameters

The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a critical quality attributes is large enough to make a practically meaningful impact.
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FACILITY DESIGN

Flexibility vs. Right-Sizing: Determining the Right Facility Size

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.
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REGULATORY

Tackling Regulatory Challenges of EU’s Variations Framework

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.
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API SYNTHESIS AND MANUFACTURING

Polymorph Screening for Identification of Relevant Crystalline Forms

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.
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TROUBLESHOOTING

Designing a Biomanufacturing Facility Incorporating Single-Use Technologies

Asking the right questions is crucial to establishing a facility design.
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OUTSOURCING OUTLOOK

Pharma Outsourcing Market Expands

The pharma outsourcing market starts 2016 with expansions, acquisitions, and new offerings.
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ASK THE EXPERT

Phase-Appropriate GMP

Siegfried Schmitt, principal consultant, PAREXEL, discusses the regulatory requirements for CGMPs in the different phases of drug development and manufacture.
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FROM THE EDITOR

Harnessing the Potential of Smart Glasses

Smart glasses enhance remote troubleshooting and process management for pharmaceutical manufacturing.
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FEATURES

Qualification and Validation of Single-Use Shipping Systems

The authors provide their perspectives on shipping validation.
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Outsourcing Formulation Development for High-Potency Compounds

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.
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Lab Services: To Outsource or Not to Outsource

Outsourcing lab analysis offers savings, while “workhorse” techniques can improve the efficiency of such core operations as stability testing.
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Keeping It Simple: Collaborating for Success in Drug Delivery

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.
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Quality Metrics and Best Practices for Working with Contract Labs

Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.
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Webcasts

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

On Demand
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.
Sponsored by AMRI

Establishing a Risk Management Plan for Compliance and Pharmacovigilance

On Demand
Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency's Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
Sponsored by EtQ