Newsletter | March 15, 2023

03.15.23 -- CPHI Report: Shifting Outsourcing Realities

From The Editor
Featured Editorial
Industry Insights
Fermentation Optimization: Using Comparative Statistics

Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 108 U/batch.

Bridging The Gap Between Drug Substance And Drug Product

It can often feel like the drug substance group simply passes the drug substance across a fence to the drug product group for further processing without any real communication.

Transitioning From Vial To Prefilled Syringe

Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Optimizing AAV Manufacture Purification

Adeno-associated viruses are becoming the vector of choice for delivering therapeutic genes. Learn more about technology being explored to unlock their full potential.

Five Dangers Of An Insecure API Supply Chain

The diversity and agility of API supply chains are key to ensuring that medicines can be manufactured and delivered to patients on time, even in the face of challenges and unforeseen circumstances.

Method Transfer: When, Why, How?

A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results.

The Digitalization Of Biopharma Process Development, Manufacturing

The fourth industrial revolution is coming. Explore the three essentials of bioprocess development and manufacturing digitalization: digital literacy, digital trust, and prioritization.

How To Use QbD Software To Improve An Existing Identification Method

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

Drug Discovery And Screening, A Digital Era For RNA-LNP Therapeutics

Learn about the key stages of drug discovery and screening, along with how to overcome key bottlenecks in screening mRNA-LNPs, to rapidly develop genomic medicines.

Scale-Up And BLA Planning For Microbial Biomanufacturing

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

CDMO Timebombs: Five Ways The Wrong Partner Can Lead To Trouble

A manufacturing partner that can't manage the complexities of your biologic can cause problems large and small, putting your next level of funding, or even the future of your company, in jeopardy.

Pediatric Dosage Forms: Reformulation And Development Expertise

Infrastructure and expertise cover the sweet spot for producing the small-to-midsize batches needed to meet industry demands for PDFs and orphan drugs, and extend to large-scale manufacturing as well.

Quality By Design: The Highest-Standard Approach To Process Validation

The challenge was to develop and validate manufacturing processes for two novel molecules, one in Phase 1 development and the other in Phase 3.

3 Important Developments In Aseptic Connection Technology

Learn about the latest aseptic connectors to help optimize today’s processes and get a sneak peek into the future of single-use technology.

Utilization Of Titration Curve Modeling In Bioassay Potency

To overcome growth condition variability and the plotting of titration curves to measure any effect on the targeted mechanism of action, explore a modeling tool to predict cellular response.

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