Featured Articles
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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.
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Advantages Of Working With An Embedded CMO
An embedded CMO offers many advantages over other CMO models, not least its access to the extensive capabilities and knowhow of the parent organization.
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Expedite Commercial Launch Readiness For ADC Manufacturing
An effective strategy will reduce the probability of late-stage process, analytical, or manufacturing site changes which could put chemistry, manufacturing and controls (CMC) activities on the critical path.
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Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process
Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.
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Driving Continuous Improvement With A Fully Integrated Quality System
A well-designed quality system has a global scope, incorporating guidelines from all relevant markets and assuring data quality and integrity through adherence to quality standards, policies, and procedures.
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An Integrated Supply Chain In Contract Biopharmaceutical Manufacturing
As worldwide demand for biological therapies continues its path of significant growth, CMOs will continue to become an ever-increasing, critical element of the biopharmaceutical supply infrastructure.
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CMO As Partners For ADC Process Development, Scale-Up, Optimization
ADC programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.
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An Enabling Technology: Hot Melt Extrusion
Whether you wish to improve the bioavailability, enhance the solubility, mask an unpleasant taste, modulate drug release, or address drug stability issues, extrusion can deliver on these objectives and more.
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Embedded CMO: From Development Through Commercialization
The right CMO can expedite market launch, and an embedded CMO offers many advantages over other CMO models, including access to the extensive capabilities and knowhow of the parent organization.