CRBlogs in Biotechnology

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An artistic portrayal of adeno-associated viral vectors used in gene therapy manufacture

Advanced therapy medicinal product facilities through the eyes of a process architect

Grace Linton
Advanced therapy medicinal product (ATMP) companies are ushering in a new frontier of medicine and technologies poised to revolutionize human health. The industry is advancing at such a rapid pace that these companies are faced with vast new complexities when developing and manufacturing their products.  
Don’t reinvent the wheel—refine the heck out of it

Don’t reinvent the wheel—refine the heck out of it

Howard Sneider
I love being presented with a design challenge, but arriving at the final answer can be arduous and time consuming without a path to follow. In the process of taking the steps to the solution, the strategy becomes less daunting, and the method becomes more comfortable. 
To outsource or not to outsource? That is the question: How to ensure your CMO stacks up

To outsource or not to outsource? That is the question: How to ensure your CMO stacks up

Kevin Debbs and Christa Myers
The age-old debate of whether to outsource production to a contract manufacturing organization (CMO) remains for mature, emerging and virtual biopharmaceutical companies. 
Improving Documentation Change Control Process

Improving Documentation Change Control Process

Niranjan Kulkarni
In regulated environments, companies are expected to establish procedures for document change control as a way of ensuring product quality and safety. Any changes made to the product, system or facility, (e.g., manufacturing, processing, quality assurance/quality control, information technology (IT), etc.) need to be documented in a timely manner. Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times.
Flexible Design and Nimble Systems Help Prepare for a Biomedical Emergency

Flexible Design and Nimble Systems Help Prepare for a Biomedical Emergency

Allan Bream and Grace Linton and Matthew Khair and Jack Striebel
A global specialty biopharmaceutical company entered into a public-private contract worth $220 million with the Biomedical Advance Research and Development Authority (BARDA) in 2012. Its primary goal was to establish a Center for Innovation in Advanced Development and Manufacturing (CIADM) to address challenges encountered in developing biodefense medical countermeasures.
Personalized Medicine - Diagnostics Will Lead the Way!

Personalized Medicine - Diagnostics Will Lead the Way!

We have been talking about Personalized Medicine for years. "Wouldn't it be better if the medicine that I was taking was designed just for me?" We all know that personalized medicine would greatly benefit individual patients. 
So You Have a Biofilm, Now What?

So You Have a Biofilm, Now What?

CRB’s Christa Myers, Associate, Process Specialist and Project Manager, recently held an INTERPHEX Live video chat about the challenges with Biofilms.
Next Generation Biomanufacturing - Leveraging the Benefits of Continuous Closed Processing

Next Generation Biomanufacturing - Leveraging the Benefits of Continuous Closed Processing

Matthew Kennedy and Steve Attig
Steve Attig and Matt Kennedy recently spoke at Interphex 2015 on next generation biopharmaceutical manufacturing facilities that significantly reduce a facility footprint, capital investment, manufacturing cost of goods, and improves utilization of assets when compared to conventional batch processing.
Simulation Software Enhances Packaging Line Design

Simulation Software Enhances Packaging Line Design

Modeling tool helps companies right size equipment for efficiency and savings.
Importance of Information Sharing in Cold Chains

Importance of Information Sharing in Cold Chains

Niranjan Kulkarni
To ensure quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout supply chain. In cold chains, temperature is closely controlled and monitored.
Leveraging Design To Minimize Risk

Leveraging Design To Minimize Risk

Matthew Kennedy and Matthew Khair
Learn how the application of best practice design principles can help mitigate the risks confronting biotechnology companies when navigating the uncertainty surrounding the demand profile of its product pipeline.
Building a Thoughtful Manufacturing Supply Chain

Building a Thoughtful Manufacturing Supply Chain

J. Lee Emel
In the past 5 years, the biopharmaceutical industry has seen unprecedented change. Precipitated by the need to support a global client base with products that are more targeted, efficacious and cost effective, the challenge to have a robust manufacturing supply chain is more crucial than ever to a company’s survival.
Understanding Waste From A Lean Biopharmaceutical Perspective

Understanding Waste From A Lean Biopharmaceutical Perspective

Niranjan Kulkarni
As pressure to cut costs continues to grow, CRB Operations Improvement specialist, Niranjan Kulkarni, PhD, assists manufacturers in implementing Lean and Six Sigma methodologies to eliminate waste and maximize profits.
Process Simulation and its Benefits

Process Simulation and its Benefits

Philip Lyman, PhD – Director of Process Simulation at CRB – discusses how a process model, at the right detail level and properly validated, can be an invaluable tool to compare alternatives and justify cost for manufacturing and manufacturing-related processes.