Newsletter | December 2, 2019

12.02.19 -- International Reference Pricing: The Answer To Rising Drug Costs?

Featured Editorial
International Reference Pricing: The Answer To Rising Drug Costs?
By Matthew Pillar, editor, BioProcess Online

Political leaders on both sides of the aisle are mulling government-mandated international reference pricing as means of controlling the spiraling cost of biologics and other prescription medicines. Here's what that might look like, and why it's unlikely to happen in short order.

Sampling And Testing Of ATMPs: Gaining Insights From PIC/S Annex 2A
By Herman F. Bozenhardt and Erich H. Bozenhardt

With minimal specific guidance on commercial manufacturing from the FDA, and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel as if they are walking on a precarious limb.

Industry Insights
Considerations For Upstream Biologic Development
White Paper | By Dr. Joe S. Orlando, Ph.D., MilliporeSigma Emerging Bio

The path from DNA to clinic to drug-in-vial is long and complex, and choices made during upstream development can strongly influence the success of a biologic candidate. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.

Single-Use Platforms Accelerate Viral Vaccine Development And Manufacturing
White Paper | By Amélie Boulais, Sartorius Stedim Biotech

Biopharma analysts predict the market for vaccines could grow at a compounded annual growth rate of as much as 10.3 percent through 2024. Single-use platforms that eliminate reinvention of the wheel for each candidate might be pivotal to meeting that demand.

Novel Uses For Oral Solid Doses Driving Lifecycle Management Strategies
Article | By Anil Kane, Ph.D., Thermo Fisher Scientific

With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.

Automating And Enclosing Bulk Fill Operations: The Way Forward?
Article | By Graeme Proctor, Parker Bioscience Filtration

Understand the disadvantages of traditional bulk fill operations and learn how an automated and integrated single-use system for final bulk filtration helps overcome those obstacles.

Optimize Your Lyophilization Process Using Minimal Drug Substances
Article | By Jeff Tremain and Ted Tharp, AbbVie

Scale-up and technology transfer of lyophilization processes remain a challenge. Here's how advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.

Avoid Costly Mistakes In Gene Therapy Process Development
White Paper | MilliporeSigma Cell and Gene

Success in the evolving and highly competitive gene therapy space requires navigating many uncertainties related to process development and manufacturing of adeno-associated virus (AAV) and lentivirus vectors. These tips will guide development and manufacturing teams operating on compressed timelines.  

Leverage The Internet Of Things Within The Laboratory
White Paper | Dassault Systemes Americas

As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms. 

A Model System For Fast Screening Of Optimal Protein Purification Conditions
Application Note | Bio-Rad Laboratories, Inc.

Identifying optimal purification conditions can require time-consuming evaluation of many parameters. This study highlights a model system for screening optimal protein purification conditions on a mixed-mode cation exchange resin using a statistical software-generated design of experiment model.

An Intensified Fed-Batch Process Utilizing N-1 Perfusion And ambr 15
Poster | Catalent

While traditional fed-batch bioreactor process development has been well defined using methods such as shake flasks and bench-scale bioreactors, there is a desire to intensify the fed-batch process strategy to increase efficiency and productivity.

Strategies For Optimizing Upstream Processes Cell Culture
Poster | Thermo Fisher Scientific

The cell culture process is crucial for maximizing the production of biologics and vaccines, optimizing product quality attributes, minimizing impurities, and simplifying operations. These case studies demonstrate how optimizing the composition and format of media supports upstream strategies.

Leverage Machine Learning For Faster High-Content Analysis
Video | GE Healthcare Life Sciences

Here's how scientists from the University of Washington are leveraging machine learning to automate and simplify the complex process of identifying phenotypic subpopulations for faster high-content analysis.

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