Featured Articles
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Tackling The Challenges Of Biologics Development And Manufacturing
Biologics are a growing, promising solution to address unmet medical needs. It is critical to have the right manufacturing partner to minimize challenges as a therapy moves from discovery to commercialization.
-
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.
-
3 Key Considerations When Choosing A Partner For Your Tech Transfer
One way to streamline tech transfer is to partner with a CMO demonstrating a proven track record across the entire drug development and manufacturing continuum.