Featured Articles
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Increase Solubility And Bioavailability With Hot Melt Extrusion
3/22/2019
When executed properly, HME advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.
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Exploring Bilayer Tablet Manufacturing
3/21/2019
This Q&A reviews selecting this dosage form, manufacturing challenges and how to overcome them, considerations for evaluating a CDMO, and the typical timeframe for scale-up.
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Is Your CMO Ready For Serialization And Aggregation?
3/20/2019
While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?
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Avoiding HPAPI Contamination
3/20/2019
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes, and deploy appropriate containment strategies.
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Using A CMO To Streamline Process Characterization
3/19/2019
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex.
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Track-And-Trace In The Drug Supply Chain
More and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. As global guidelines take full effect, understand how CMOs are preparing to comply to meet their customer needs.
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Solutions To Clinical, Commercial Challenges In Pharma Development
Explore solutions to common quality, market demand, supply, and international manufacturing challenges faced when bringing new therapeutics to market.
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What Your CMO Needs To Know About Serialization And Aggregation
Partnering with a CMO that has applied traceability, serialization, and aggregation standards across its operations promises business continuity and speed-to-market that translates to a competitive advantage.
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What Dosage Form Provides A Release Drug Control Rate?
Whether your goal is to increase patient compliance, improve clinical outcomes, or to extend a product’s lifecycle, modified-release dosage forms present a solution to myriad challenges.
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Selecting A CMO: Top Considerations
Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. Here are tips to ensure a successful outcome.