Newsletter | June 13, 2022

06.13.22 -- Process Development: The Rodney Dangerfield Of Outsourcing?

 
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From The Editor
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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.

Single-Arm Trials Using Real-World Evidence For Rare Disease Product Development

In rare disease drug development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. In this blog, gain insight into the regulatory considerations for single-arm trials.

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.

Plasmid DNA cGMP Production: Finding The Right Partner

Partnering with a CDMO equipped with the quality oversight, capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply. 

Advanced Formulation Development By Design: Holistic Drug Production

Drug substance/drug product biomanufacturing complexity is increasing. Solving challenges calls for innovative mindsets, advanced technology, and proficient and complementary expertise.

Mitigating Hidden Risks: Extractables And Leachables

Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

Improvements Toward Standardizing Viral Vector Manufacturing And Producer Cell Line Development

The TRiP System™ allows suppression of transgene expression during upstream processes, resulting in enhanced vector yield and purity, simplifying downstream processes.

How To Safely Handle Your Antibody Drug Conjugate

Experts explore key factors involved in ensuring the safe handling of ADCs, including toxicological assessment, risk assessment, best practices for containment, and occupational hygiene monitoring.

Creating Flexibility And Efficiency In Isolator-Based Filling With Robotics And Automation

Explore the development of isolator-based filling systems, the improvements in technology over the last few decades, the introduction of robotics and technology, and a case study for the optimal solution for sterile, isolator-based filling.

Meeting Demands Of Accelerated Timelines Using Solid Form Screening And Rapid Formulation Selection

A comprehensive approach to evaluating drug molecules for the selection of a lead solid form and formulation can significantly accelerate development timelines and limit risks in later development.

The Changing Landscape Of Oncology Drug Development: Bringing Novel Lifesaving Therapies To Patients

This white paper provides strategic guidance for successfully navigating complexities, such as unique formulation and handling requirements, novel trial designs and the supply chain implications, and regulatory and clinical strategies to support product approvals.

Softgel Technologies Overview

Innovative softgel technologies that maximize your market potential: Where ideation and expertise come together.

Examining The Emergence Of Unit- And Bi-Dose Nasal Sprays

Nasal spray administration of medicine offers advantages over oral and intravenous (IV) delivery. Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology.

N-Linked Glycan Analysis For Complex Glycoproteins

An established cell line and a bench-scale manufacturing process for a complex glycoprotein produced high-quality material but had a low yield and was not scalable.

Tech Transfer In Sterile Injectables: 3 Phases Of Success

Explore the three phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

Strategies, Emerging Technologies For mAb Capture

Explore opportunities with the introduction of high-capacity protein A resins, how and when multicolumn chromatography is beneficial, and how emerging technologies can address bottlenecks.

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