Newsletter | September 23, 2021

09.23.21 -- Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing

 
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Track-And-Trace In The Drug Supply Chain

Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. 

Bayer Evaluates Fibro For Scalable Single-Use Monoclonal Antibody (mAb) Purification

Learn how Bayer evaluated Fibro PrismA chromatography to determine its potential as a true single-use mAb capture technology. They assessed scalability from lab- to process-scale tracking pressure drop, step recovery, purity, and eluate volumes across multiple cycles. Read the outcome here.

Navigating An Ever-Changing Landscape: The Role Of A CFO In A Private Equity Controlled Pharma Company

The role of chief financial officer for a small-to-midsize pharma company controlled by private equity is a challenging one, especially since pharma companies with limited internal resources often rely on CDMOs for support. Learn how these CFOs can use their CDMOs to be more successful.

Increasing Transparency And Confidence Through Real-Time Data Sharing

A digital transformation of biomanufacturing offers a new path for continuous monitoring and optimization of process performance, which would ultimately lead to greater efficiency in drug production.

The Path To A Secure Supply Chain: 10 Questions To Ask

API supply is all about balancing risk. Preparing to ask and answer these 10 questions can provide clarity and confidence in your supply chain.

Unpacking The Complexity Of In Vitro Intestinal Models

There is a growing need to address the high failure rate of drug candidates as they progress through clinical trials. Read how technological advances are enabling the drug development process to more effectively translate results from preclinical experiments to late-stage clinical trials.

8 Misconceptions About Embedded CDMOs

Access to the expert capabilities of embedded CDMOs is offering great economies and competitive experience to the sector.

Analytical Services: Risk Management In Prefilled Syringe (PFS) Components Selection For Sensitive Biological Drug Formulations

Choosing the right containers and materials is critical but difficult, and no methodology can quickly assess the risk of drug/device interaction. Two risk-based test methodologies help to select the optimum closure materials and the correct syringe silicone level at the early phase of drug development.

Are You Prepared For The Complexity Of Pediatric Drug Development?

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

Choosing The Right CDMO For HPAPI Development, Manufacturing, And Packaging

Pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging, and commercialization of products containing high-potency active pharmaceutical ingredients (HPAPIs). Experts discussed the key considerations and best practices when outsourcing HPAPI development, manufacturing, and packaging to a CDMO.

Five Ways To Get To IND/IMPD Faster

How do you get to IND/IMPD faster without sacrificing quality and future commercialization goals? Our experts share a few considerations when thinking about accelerating and optimizing your early development process.

Micro-Flow Imaging Enables Cutting-Edge Biopharmaceutical Research

Protein aggregation and the formation of subvisible particles can significantly impact the safety and efficacy of biopharmaceuticals. Therefore, protein aggregation and subvisible particle content must be carefully monitored during in-process and final product development. Micro-Flow Imaging (MFI), a powerful system to analyze protein aggregates and other subvisible particles in your samples, can assess the stability of antibody-based biotherapeutics in response to stress.

A Q&A: Manufacturing Dry Powder Inhaled Formulations By Spray Drying

Dr. Kimberly Shepard, Ph.D., associate principal engineer in R&D, answers attendee questions from a recent webinar about how spray drying can be used to address many of the challenges associated with today’s late-stage lung cancer treatments.

Keys To A Successful Rapid Commercial Launch

For new biologics and drug development, the quicker a company can get its product to patients, the better. Combining a rapid launch following regulatory approval with effective messaging and post-launch services can provide a competitive advantage.

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