Newsletter | May 14, 2019

05.14.19 -- Contextual Communication's Impact On Data Integrity

 
Sponsor
  Biologic Sterile Injectable Drug Product Manufacturing Market Overview And Outlook
 

This market research report provides an overview of the current biologic sterile injectable market dynamics as well as what our survey respondents — all outsourcing decision makers — predict the market will look like in 2022. Key statistics include development-stage and marketed product volume, the proportion outsourced, and the number of CMOs required to complete the work. You can purchase the report or download a free preview by clicking here.

Featured Editorial
To Err Is Human: Contextual Communication’s Impact On Data Integrity
 
By Kip Wolf, Tunnell Consulting, @KipWolf

Despite the best efforts of those directly responsible for data integrity, human error will still find its way into the equation and undermine the efforts. Even the most mature organizations with the most evolved data integrity practices likely experience turnover or new hires who must be integrated into the organization’s cultures and operations.

Merck's Best Practices To Implement Strategic Sourcing Partnerships
By Panagiota (Pam) Rizos, associate director, external operations, global regulatory affairs and clinical safety, Merck & Co., Inc.

Here are the final five best practices that Merck undertook to effectively extend its capacity through strategic outsourcing, which focuses on building a strong foundation with external partners.

Industry Insights
Avoiding HPAPI Contamination
White Paper | By Olindo Lazzaro and Max Brescia, AbbVie

Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes, and deploy appropriate containment strategies. 

How Biopharma Is Capitalizing On The Antibody Boom
Article | By Günter Jagschies, GE Healthcare Life Sciences

Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.

Top 5 Risks Facing Your Small Biopharma Clients Today
Article | By Stephen Lam and Jennifer Stone, Thermo Fisher Scientific

For small biopharma innovators steep development costs are compounded by the fact that large molecules are becoming increasingly complex and present serious clinical or manufacturing problems.

Selecting The Best Pharmaceutical Mixing Equipment For Your Operations
Article | By Ken Langhorn, Charles Ross and Son Company

Finding the right mixing equipment isn’t as simple as selecting an item from a menu. This article is a guide to factors to consider when choosing pharmaceutical mixing equipment and vendors for a facility.

The Importance Of Strategic Alliance Partners In Biopharmaceuticals
Article | By Maria Barajas, West Pharmaceutical Services, Inc.

Today’s drug delivery systems are complex technologies that require close teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms.

Route Scouting In API Development: A Luxury Or Necessity?
Article | Piramal Pharma Solutions

Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus, a new field of chemistry called process research was born.

The Effect Of Shape For The Prediction Of Powder Segregation In Pharmaceutical Solid Dosage Form Applications
Article | Micromeritics Instrument Corporation

Avoid inconsistent and even dangerous dosages being tableted by monitoring segregation during the process.

SUB Enhancements For High-Density Perfusion Cultures
Application Note | Thermo Fisher Scientific

This study presents how strategic enhancements to the sparge and agitation systems of Thermo Scientific HyPerforma SUBs have revealed the potential for a three- to four-fold improvement in mixing and mass transfer performance compared to legacy SUB designs.

Single-Use Flexible Containment Systems For Charging And Offloading Pharmaceutical Powder Transfer Operations
Application Note | ILC Dover

Don’t risk operator exposure and potential contamination with untested or unproven single-use valve technologies. 

Life Science Leader Magazine
 

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