CRBlogs in Pharmaceuticals

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Continuous OSD manufacturing—A 2019 technology update

Continuous OSD manufacturing—A 2019 technology update

David DiProspero
The system types being employed in today’s modern oral solid dose form manufacturing facilities
Aseptic technique at the beach

Aseptic technique at the beach

Howard Sneider
Last month, while I was on a beach vacation with my family, I disconnected from the daily onslaught of emails and projects for some much-needed rest and relaxation. While I consciously made the decision to not think about work, my subconscious had other plans; I observed a typical scenario on the beach and discovered it was a fantastic metaphor for indiscernible lapses in aseptic technique.
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. 
Can’t hack it? Why pharma should heed the growing threats to cyber security

Can’t hack it? Why pharma should heed the growing threats to cyber security

Steven Pflantz
Who would want to hack a programmable logic controller? If you have watched any news as of late, you will notice a routine story line about the occurrences of cybersecurity attacks. It seems that the hackers are working over time trying to cause all manner of trouble. 
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. 
Ask an Expert - Designing an OSD Facility to Protect Drug Products

Ask an Expert - Designing an OSD Facility to Protect Drug Products

David DiProspero
As appeared in Tablets & Capsules - Solid Dose Digest, July 10, 2017 Q: How we can best design an OSD facility to protect our drug products from physical, chemical, and biological contamination during manufacturing?
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.
Continuous OSD Manufacturing

Continuous OSD Manufacturing

David DiProspero
Why the Shift from Batch to Continuous for Pharmaceutical Oral Solid Dosage Form Tablet Manufacture is Now Upon Us
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. 
Design Improvements for H2O2 Decontamination

Design Improvements for H2O2 Decontamination

Kevin Debbs
There have been design improvements over the last few years related to H2O2 decontamination, namely the use of atomized spray of liquid hydrogen peroxide at ambient temperature vs. vaporization and the integration of a catalytic converter.  
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.
Drug Supply Chain Security Act – Enterprise Disruption

Drug Supply Chain Security Act – Enterprise Disruption

Steve Peterson and Mike McKillop
The Drug Supply Chain Security Act (DSCSA) 2017 deadline to domestically ship your Rx products with a unique serial identification number is now less than three (3) years away.  Taking into account contingency, this leaves companies approximately 2½ years to implement an enterprise wide serialization system that will impact nearly every group within their organization.  The disruption to existing manufacturing and distribution processes will be significant. 
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.
To Outsource or Not? That is the Question

To Outsource or Not? That is the Question

Christa Myers and Kevin Debbs
The age-old debate for mature, emerging and virtual biopharmaceutical companies remains whether to outsource production to a contract manufacturing organization (CMO) or not?
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.