Featured Articles
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Lyophilization Of Highly Potent Drugs: Facility, Equipment Considerations
5/24/2019
Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
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Accelerate Time To A Robust And Reliable Commercial Scale Process
5/24/2019
This five-step platform approach to process characterization ensures the entire process is right first time and results in a highly consistent product to facilitate efficient BLA filing.
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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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How To Avoid High Potency API Contamination
3/22/2019
Having standards in place for engineering controls is the first line of defense against cross-contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs.
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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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Putting The “Process” Into Process Characterization
3/19/2019
Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.
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Advantages Of A Lipid-Based Drug Delivery System For Poor Bioavailability Drugs
3/19/2019
There are a number of reasons to choose a Lipid-Based Drug Delivery System over conventional formulation approaches when working with poorly soluble compounds.
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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.