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Choosing The Best Regulatory Pathway For Microbiome Products

There is a regulatory grey area between healthcare and consumer health products, often causing confusion for brands entering this space. The microbiome is one area that is bringing new challenges, because much of the science supporting microbiome product claims are very new and remain unproven in many cases.

EDITOR'S DESK

Virus Exposes Weak Links In The Biopharma Supply Chain
In early March, the life sciences investment firm SVB Leerink hosted a conference call that exposed just how big a problem COVID-19 presents to US biopharma innovators.

Is Biopharma’s Response To Coronavirus Off The Mark?

As biopharmas aplenty race to develop a vaccine, CureLab’s Alex Shneider says an incorrect approach risks turning the currently insignificant coronavirus threat into a deadly pandemic. He suggests that we instead focus on the development of adjuvants and immunostimulants to protect the elderly.

COVID-19: A Case For “Virtual” Biopharma?

Work-and-learn from home policies are more than employee perks. They could help thwart a pandemic. Have you adopted procedures and tools that ensure continuity when employees aren’t in the office?

The Process Behind The Potential: Therapy For HPV16-Related Malignancies

HPV-related malignancies are poised to skyrocket over the next thirty+ years. Here's a look into Cue Biopharma’s engineering-centric approach to in vivo tumor antigen specific T cell activation to treat these cancers.

Update On Advanced Rapid Microbiology Methods In Biopharma

A BioPhorum survey of biopharma end-users reveals the opportunity—and the challenge—involved in the adoption of advanced rapid microbiology methods. Audrey Chang, global head of development services at BioReliance Merck; Morven McAlister, senior director at Pall Biotech; and Scott Hooper, associate director at Merck & Co Inc. break down the data.

GUEST COLUMNISTS

COVID-19, Medical Drones, & The Last Mile Of The Pharma Supply Chain
During crises like this pandemic, bottlenecks in drug distribution and sample testing can be improved through automation, artificial intelligence, and robotics. This article provides an overview of the medical drone industry, with a particular emphasis on its adoption by the pharmaceutical sector to solve logistical problems in healthcare during times of heightened need.
Stand By To Stand By: Organizational Contingency Planning
The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.
EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications
While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.
Implementing Data Quality By Design For Improved Data Integrity
We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.
Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies
One of the most frequent statements made in the biopharmaceutical industry is the need to “control a product’s critical quality attributes (CQAs) by controlling the process’ critical process parameters (CPPs).” While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.
Which Biosimilar Companies Will Thrive In 2025?
Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.
Biosimilar Pipeline Experiencing 12% Annual Growth: A Progress Update
This article compares aspects of the biosimilar development pipeline and related market evolution over the past seven years, since 2013, including what has and hasn’t changed.
COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain
To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.

BIOPROCESSING WHITE PAPERS

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Adoption Of Single-Use For Final Filtration
Moving from stainless steel to single-use assemblies for final filtration helps meet production demands and cut costs. Pre-use integrity and prototype testing and handling are important considerations.
Upstream Bioprocessing In Food And Feed Applications
Bioprocessing has been used for decades for the industrial production of beverages and for the production and preservation of food and feed ingredients.
Advantages Of Single-Layer Film Vs. Multilayer Film In Bioprocessing
Speed and flexibility are critical to succeed in the bioprocessing market. Plastics technology enables small-batch, single-use packaging solutions for customized drugs to serve a smaller patient population.
Minimizing Sterile Filtration Risk Through Quality By Design
Steps to ensure products are free from microbial contamination and achieve a sufficient level of risk mitigation against potential bioburden issues for these applications.
Optimizing Process Parameters Simultaneously: Design Of Experiments In Bioprocess Development
Develop efficient and robust processes by using Design of Experiments, a method that can uncover complex relationships while saving resources.

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BIOPROCESSING APP NOTES & CASE STUDIES

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NEWSLETTER ARCHIVE

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BIOPROCESS ONLINE CONTENT COLLECTIONS

This e-book shares some of our experiences in the more hazardous areas, and in turn challenges you to look at your facilities and operations to apply some basic safe design philosophies to whatever you are working with, potent or not. We sincerely hope you enjoy them and continue to be safe.