Newsletter | August 29, 2019

08.29.19 -- Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace

 
Sponsor
  Digitally Connect Prefilled Syringes And Autoinjectors
 

Medication adherence is a significant challenge in today’s healthcare system. SureMed Tech is tackling this issue with technologies that allow you to easily add e-connectivity capability to your prefilled syringes and autoinjectors for clinical trials and commercial adherence programs. Our products are designed to be low cost and easy to implement, providing a seamless user experience with no disruption to existing medication steps. To learn more, contact us at info@suremedtech.com or visit http://www.suremedtech.com.

Featured Editorial
Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace
 
By Jerry Martin

From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain.

Customer Loyalty In Small Molecule Drug Product Manufacturing

In Q42018, ISR surveyed 136 sponsors who outsource drug product manufacturing for small molecule compounds to gain insight into their CMO loyalty. ISR computes customer loyalty as an index that consists of overall satisfaction, willingness to recommend, and likelihood to use the CMO again.

Industry Insights
Benefits And Challenges Of Driving Modernization In Vaccine Development
White Paper | By Manon M.J. Cox, Matrivax

Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

The Case For A Facility Monitoring System
White Paper | By Tim Russell, TSI Incorporated

While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.

Blow-Fill-Seal For Biologics: Breaking Through In Pharma Packaging
White Paper | By Bill Hartzel, Catalent, and Andy Goll, Weiler Engineering, Inc.

As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. 

Where To Next With Continuous Processing?
Article | By Peter Levison, Pall Biotech

Today, multiple suppliers offer commercial process solutions for continuous cell culture, continuous clarification, continuous chromatography, continuous virus inactivation, and continuous filtration; their effectiveness is documented in the technical literature. So, what’s next? We have the tools, the technology is proven, and early adopters are active.

Developing A High-Throughput Formulation Development Platform For High-Concentration, Therapeutic Monoclonal Antibodies
Poster | By Jessica Ripley, Shyamal Choudhari, Lun Xin, Spencer Beard, Victor Vinci, and Yunsong Li, Catalent

Two of the challenges in the early stages of a pharmaceutical are a limited supply of protein to use in formulation screening studies and a need to obtain stability data quickly to initiate tox studies. In this poster, scientists at Catalent Biologics outline a method utilizing a high-throughput, microwell plate platform to economically screen a mAb in 96 formulations.

How To Choose Alkaline Or Acid Pharmaceutical Cleaners
White Paper | Alconox, Inc.

A great deal is known about how pH affects aqueous critical cleaning. The first step is for you to identify the residue that needs to be removed and then determine the optimal pH range that will remove it. By understanding the structure, functional groups, molecular polarity, solubility, and molecular weight of the residue being removed, it is possible to determine if an alkaline or acidic cleaner would work best for a given cleaning method.

Are You Prepared For The Complexity Of Pediatric Drug Development?
Article | Thermo Fisher Scientific

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

100% Container Closure Inspection Of Freeze-Dried Drug Product In Quarantine
Case Study | Lighthouse Instruments

A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100 percent container closure inspection of the product vials with the help of LIGHTHOUSE.

Manage Risks In Development And Manufacture Of Potent Pharma Products
Case Study | Pharmaceutics International

Given the variety of potent drugs in development, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multiuse facility, is an effective strategy.

Sponsor
  Clinical Trial Supply East Coast 2019
 

CTS East Coast 2019 will return to King of Prussia, where large and small pharma and biotechs will have the opportunity to discuss, debate, and consider new technologies and processes to streamline supply chain operations. With multiple solutions providers exhibiting their solutions and co-presenting, this meeting promises to showcase best practices and techniques that are translatable into practice.

Solutions
Custom Kit Packaging
B. Braun OEM Division
Global VersaWeigh And Global Versa GP Checkweighers
Thermo Scientific Product Inspection
IMA High-Speed Capsule Checkweighers, Model Precisa 120
Federal Equipment Company
Meissner Capsule Filters
Meissner Filtration Products
Specialized Pharmaceutical Packaging Solutions
Almac Group
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