With an increased number of products on accelerated regulatory approval pathways, this puts increased pressure on CMC development to support shortened BLA submission timelines. This is the point at which mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.
Learn about a holistic development strategy that will help reduce risks while considering the patient and final market presentation. Understanding not only which potential issues could arise but also how an experienced CDMO can help you prepare for them will allow you to stay on track with your commercialization goals and protect your product on its path to market.
Experts answer attendee questions from a webinar about the complex path to a successful product launch, which requires a holistic development strategy driven by a well-defined target product profile. This strategy helps reduce risks while keeping the patient and final market presentation in mind.
Lonza has introduced integrated offerings intended to reduce the development timeline and improve overall productivity. Learn how an integrated drug substance and drug product CMC strategy for recombinant proteins can help deliver tailored product-specific solutions and enable the acceleration of this type of novel molecular formats into the clinic.
The goal of in-use testing of biotherapeutics is to ensure acceptable product quality during dose preparation and administration to patients. Considering the wide range of in-use conditions and administration systems and set-ups available, this webinar will discuss some of the more challenging aspects surrounding in-use testing for parenteral delivery while reviewing potential strategies to address these issues. Click here to learn more.
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