Newsletter | May 17, 2016

05.17.16 -- Some Biopharma Haven't Caught Outsourcing Enthusiasm

Featured Editorial
Some Biopharma Haven’t Caught Outsourcing Enthusiasm
By Louis Garguilo, Executive Editor, Outsourced Pharma

I often write — and you read — about those individuals at biopharma companies openly enthusiastic about outsourcing. Not too long ago, though, I ran into a person who seemed to outdo the others in absolute embrace of this model. But here’s the catch: Her company won’t allow her enthusiasm to be shared “on the record.”

Industry Insights
9 Steps To Remember When Performing A Supply Chain Risk Assessment
Article | By Piritta Maunu, Regulatory Expert, Vaisala, Inc.; Assistance by Jim Tennermann and John Martin
This article provides practical tools for creating a risk assessment procedure related to good distribution practice (GDP) guidelines.
The Renaissance Of Sprinkle Formulations
White Paper | By Sven Stegemann, Ph.D., Capsugel

About 25 years ago, multiparticulates were applied in pharmaceutical product development as so-called sprinkle formulations to overcome swallowing issues with larger oral dosage forms. After a growth in popularity in the 1990s, use of sprinkle formulations declined because of concerns about delivery and efficacy. These issues, which can easily be overcome, are addressed in this article.

5 Questions To Ask Yourself Before Purchasing A Containment System
White Paper | By Gary Partington

If you are considering purchasing one, here are five questions to answer that will help you prepare before contacting or working with a containment system vendor.

DP Roller Technology: Why Roller Geometry Is Critical
White Paper | Alexanderwerk, Inc.
Because of their poor physical properties, virtually all dry, powder-like raw materials can only be granulated by means of roller compaction with mechanical force without a binding agent and with only slight thermal stress.
Shelf Life Studies: Basics, Principles, And Concepts
White Paper | MOCON, Inc.

Shelf life studies are used to determine how long a product can reasonably be expected to maintain its quality, safety, and character. These studies take into account not only product’s functional qualities such as safety and effectiveness, but also cosmetic qualities such as color and texture that make them appealing to customers.

Accelerate Your Process Development With High-Throughput, Single-Use, Fully Automated Bioreactors
White Paper | Sartorius Stedim Biotech

Biopharmaceutical R&D teams everywhere face the same dilemma in the development of biologics and vaccines: They must increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy.

Drivers, Risks, And Enablers In Next-Generation Biomanufacturing Environments
Article | ISPE

“Next-generation” biomanufacturing — what is it specifically and how does it differ from past and current installations?

ULD Maintenance Program Provides Optimal Performance And Longevity
Article | CSafe Global

It is critical to ensure that an active container that has been out in service for over 10 years will perform as well as a brand new container just released from our factory.

100% Inline Checkweighing Of RESCUE Remedy
Application Note | OCS Checkweighers, Inc.

A Nelson & Co Ltd., who manufacture natural healthcare remedies, have experienced an increase in production demands, therefore a solution was required for an automatic process for precise weighing and the collating of production data.

Grind And Mill Various Materials Such As Lactose
Video | Hanningfield Process Systems Ltd

The Uni-Mill M05-U can be used to grind and mill various materials. One of the most common is lactose, which is widely used as a bulking agent in pharmaceutical and food production. Lactose can be prone to clumping and caking when exposed to moisture or stored for long periods of time. Milling the lactose can repowderize the product ready for normal processing.

Pfizer CentreSource High-Containment Services
Video | Pfizer CentreSource

A narrated tour of the Pfizer high-containment facility in Freiburg, Germany, demonstrating the world-class contract high-potency, solid-oral-dose processing capabilities available globally from Pfizer CentreSource.


The good, bad, and ugly of outsourcing partnerships.

If outsourcing for drug development or manufacturing is part of your business strategy, plan to participate in Outsourced Pharma in 2016 (San Diego and San Francisco). Programs are thoughtfully curated to expose challenges and opportunities in executing sponsor-CMO partnerships. Dynamic panels, lively networking gatherings, and an intimate exhibition are hallmarks of this leading executive program. Register today.

Online Training

The Investigational New Drug (IND) Submission: Tips To Win The First Time
Date: Tuesday, May 17, 2016 • Time: 1:00 pm to 2:30 pm EDT

Identifying And Closing The Training Gap In Clinical Research
Date: Thursday, May 19, 2016 • Time: 1:00 pm to 2:30 pm EDT

Effective Problem Solving For Life Sciences Professionals
Date: Monday, May 23, 2016 • Time: 1:00 pm to 2:30 pm EDT

Computer Systems Validation (CSV): Avoiding The Top Five Regulatory Pitfalls
Date: Thursday, May 26, 2016 • Time: 1:00 pm to 2:30 pm EDT

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