Newsletter | February 4, 2020

02.04.20 -- Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?

 
Featured Editorial
Are You Prepared For Impending Changes To U.S. Biologics And Biosimilars Law?
 
By Kate Cook, Greenleaf Health

Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020, with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA (biologics license application) approval instead of an NDA approval.

Recommendations For Managing Complexity In Pharmaceutical Operations
By Jim Morris, NSF Health Sciences Pharma Biotech

There is an inherent tendency in pharmaceutical operations to make things much more complex than they need to be. “More” is considered to be better, and what regulators want to see. However, more content in an SOP, additional signatures, and new forms and control loops do not necessarily equate with “better.”

Industry Insights
Cost Advantages Of Single-Use Isolator Technologies In High-Potency Drugs
White Paper | By Scott Patterson, ILC Dover

The current trend of increased potency of drug substances is driving the need for better cleaning methods to reduce cross contamination. 

Virus Safety For Continuous Processing
White Paper | By Mark Schofield, Ph.D., GE Healthcare Life Sciences

Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

The 3 Cs You Should Expect From Your Pharma Service Provider
White Paper | By Yves Massicotte, Ropack Pharma Solutions

When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

Precise Control Of Gas Flows Within The BIOSTAT B-DCU
Application Note | By Sebastian Ruhl, Diana Hesse, Sönke Rosemann, and Ute Husemann, Sartorius Stedim Biotech

To meet the oxygen demand of cells, a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT B-DCU bioreactor system. Several comparative cell cultivations were performed.

Recommended Mixing Equipment For Ophthalmic Preparations
Application Note | By Christine Banaszek, Charles Ross and Son Company

In the processing of ophthalmic solutions, high-shear mixers are utilized for dissolving salts as well as dispersing viscosity enhancers, antioxidants, and other additives.

Decision Timeline: Considerations In Selecting An Outsourced Solution
Article | Thermo Fisher Scientific

The traditional business model for in-house pharma manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market. 

Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing
White Paper | Weiler Engineering, Inc.

BFS (blow-fill-seal) technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

HEPA vs. ULPA: Which Filter Should Your Biosafety Cabinet Use?
White Paper | NuAire, Inc.

Among the many important components determining the effectiveness of a biosafety cabinet, the most critical is the air filter.

Can You Afford Not To Outsource Buffer Preparation?
White Paper | Thermo Fisher Scientific

The decision whether or not to outsource buffer preparation is not clear-cut, but it does provide an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

Bioprocess Plant Cuts Downtime With Self-Calibrating Temperature Sensor
Case Study | Endress+Hauser, Inc.

To keep the risks in bioproduction as low as possible, an increase in calibration frequency is required. Read how the self-calibrating iTHERM TrustSens temperature sensor kept downtime to a minimum.

Satisfying Aggressive Timelines With A Simplified Supply Chain For Drug Delivery
Case Study | Thermo Fisher Scientific

To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route.

Reducing Risks With Single-Sourced Modular Cleanrooms
E-Book | AES Clean Technology, Inc.

Life sciences industries require highly controlled environments for drug research development and manufacturing.

CCI Testing To Develop ASTM Standard No. F3287-17
Poster | Pfeiffer Vacuum Inc.

The poster explains a mass extraction technology especially suitable for pharmaceutical container closure integrity testing (CCIT) applications and is acknowledged by an ASTM standard.

Sponsor
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TruBio Discovery Bioprocess Control Software
Thermo Fisher Scientific
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PTI Packaging and Inspection Systems
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