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Harmonious Harmonization: How To Get Quality System Alignment Right

This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.

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

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.
Remote Auditing Best Practices For GMP Compliance
Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

BIOPROCESSING WHITE PAPERS

Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics
Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

Choosing The Best Sterile Dosage Form For Your Phase 1 Needs
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.
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.
Avoiding Hemolysis Blood Sample Collection Processing
Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.
Shifting The Biomanufacturing Paradigm: Intensifying Upstream Processes
Demand for mAbs creates pressure to accelerate development, improve flexibility, and reduce costs while sustaining or improving drugs.This paper explores upstream strategies to increase protein titers, which can translate into higher throughput, improved flexibility, and compressed timelines.
Industry Trends Changing Sterile Filtration
To help meet the needs of both large- and small-scale operations, suppliers of sterilizing-grade filters have developed new products and technologies to help meet the needs of today’s biomanufacturing processes. Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes.

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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.