Newsletter | November 22, 2021

11.22.21 -- Demystifying Blockchain-Supported Smart Contracts

Featured Editorial
Industry Insights
Shortening Time-To-Market Through Improved Data Analytics

Improving the collection and analysis of the data a drug manufacturer produces is key to driving innovation. Novel technology solutions safeguard scale-up and optimize processes.

How To Pick The Right CDMO For Late-Phase Clinical Trials

This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.

4 Ways To Avoid Failure In Phase 3 Clinical Manufacturing

Understanding the challenges in the biopharma space is critical, as the planning you do today dictates the options you have later when the costs — and the stakes — get even higher.

Enhancing Stability, Survival, And Performance Of Microbiome-Based Products

For pharma and biotech companies focused on the development of microbiome products, it's important to develop oral dosage forms that can deliver specific formulation or application outcomes. 

Conversion Of A Viral Glycoprotein Titer Method From ELISA To BLI

In this case study, the analytical development group was provided an ELISA titer method, and the method was redeveloped to operate by biolayer interferometry (BLI) using the ForteBio Octet RED96.

Leveraging A Biomanufacturing Legacy To Support New Business

Seven diverse experts discuss how Grifols Recombinant Protein CDMO's legacy and recent investments support its future in providing recombinant protein CDMO services.

The Chemistry Of Bacterial Endotoxins: Toxicity And Immunogenicity

The diseases related to Gram-negative bacteria affect humans and animals and, in many cases, are difficult to treat, which is why it's important to have effective and bacteria-specific antibiotics.

How Fast-Track Strategies Accelerate Time-To-Clinic

Biopharmaceutical sponsors can minimize to-clinic timelines by using innovative development strategies that trade potentially increased risk for time savings.

Trends Reshaping The Future Of Biopharma Harvest And Clarification

Cell harvesting and clarifications are crucial downstream process steps. Optimizing them and delivering filtration consistency can protect downstream unit operations while reducing operating costs.

Accelerate Time To A Robust And Reliable Commercial-Scale Process

This five-step platform approach to process characterization ensures the entire process is right the first time and results in a highly consistent product to facilitate efficient biologics license application (BLA) filing.

Perfusion Medium Considerations Cell Culture

This e-book explores how to choose a perfusion medium and shares case study examples of N-1 perfusion for accelerating the seed train and concentrated fed-batch for increasing productivity.

Key Considerations For Accelerating Biologics Manufacturing

These strategies for accelerating manufacturing processes and increasing operational flexibility will help you refine your process to achieve optimal outcomes consistently, regardless of molecule.

Regulatory Services For Accelerated Development And Commercialization

Breakthrough therapy designations and other expedited regulatory reviews enable more innovation on shorter timelines to the clinic and commercialization, but they require careful navigation.

Process Development: Ensuring A Consistent, High-Quality Biologic

Gain insights on risk mitigation, the differences between innovator and biosimilar drug product process development, and what to expect from a partner during the process development phase.

Affinity Capture Of Antibody Fragments

Alkali stable Protein A resin Amsphere A3 has shown to be an effective platform capture step for a wide range of antibody fragment variants, enabling downstream process development.

Plasmid Manufacturing For Gene Therapies: An Outsourcing Partnership

With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise, and equipment for plasmid DNA production is critical.

Streamlined Selection Of In Vivo Predictive Dissolution Media

Explore the design of dissolution media to support biopredictive dissolution testing and a method for selecting practical, physiologically relevant media based upon drug, formulation, and GI fluid properties.

21 CFR Part 11 Compliance And Osmolality As A Process Parameter

FDA warning letters due to incomplete data in the pharma and biotech industries can be prevented by ensuring the reliability of electronic records, a process known as “compliance with data integrity.”

Assess Pyrogenic Risk With The Monocyte Activation Test

Learn how the monocyte activation test (MAT) provides an in vitro alternative to conventional animal testing methods in accordance with regulatory guidelines.

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