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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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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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.
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Addressing Challenges In ADC Manufacturing Control Systems
3/11/2019
Antibody-drug conjugates have a complex structure from which many impurities can arise. A control strategy design approach to small molecule impurities in ADC therapeutics can mitigate the risk.
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The Value Of Expertise In The Aseptic Fill Finish Of Biologics
Aseptic fill finish manufacturing is critical for highly valuable biologic drug substances. With vast amounts of time and resources invested upstream, loss-resulting errors at such a late stage can be catastrophic.
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Optimize Your Lyophilization Process Using Minimal Drug Substance
Here's how advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.
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How Scale-Up Benefits A Clinical Program To Get Results
A scalable manufacture promises increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, and it helps with timely delivery to market.