From The Editor
What If Our Generics Strategy Has Been All Wrong?
 
By Louis Garguilo, Chief Editor, Outsourced Pharma

What if we’ve been going at this all wrong for decades? If generics – and biosimilars – are not a sound solution for patients, hospitals, healthcare systems, governments, pharmaceutical companies, or CDMOs, when it comes to all parties profiting from the miracles of our best drugs? Part one in our investigative series.

Featured Editorial
Why CMO/CDMOs Should Seek Opportunities To Collaborate
 
By Rob Wright, chief editor, Life Science Leader

When I look at the state of the contract manufacturing and development (i.e., CMO/CDMO) industry, I see an industry ripe for disruption. After all, given the public’s consternation over drug pricing, it isn’t inconceivable to envision an outsider — perhaps with help from an insider — coming in to shake things up.

How Sherlock Holmes Improved My Microbiological Root Cause Analyses
By Paula Peacos, ValSource, Inc.

Part 1 of this two-part article contains a collection of some of the most famous quotes attributed to Sherlock Holmes that can be applied to microbial root cause analyses (RCAs). Keeping them in mind when conducting your analyses can greatly increase your chances of success in identifying that elusive definitive root cause.

Industry Insights
Microbiology Fulfills A Vital QC Role At A CDMO In Aseptic Filling And Sampling
Article | By Summer Wade, Singota Solutions

Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow clients access to data.

The Transparent CDMO: Maintain Autonomy In Biomanufacturing Partnership
Article | By Patrick Guertin, GE Healthcare Life Sciences

Complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

Managing Risks With Potent Pharmaceutical Products
Article | By Thomas Ingallinera, Pharmaceutics International

Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

It Depends: The Real Answer To The Single-Use Or Stainless-Steel Question
Article | Samsung BioLogics

During the past decade there have been innumerable comparisons between stainless-steel and single-use (SU) biomanufacturing systems. Anyone who has delved even slightly deep into the subject knows there isn’t a simple, clear-cut answer to which system is “best.” The reality is that stainless steel and SU can coexist — and often do — in today’s hybrid bioprocessing manufacturing environments.

5 Must-Haves In A Contract Packaging Partner
Article | Ropack Pharma Solutions

The pharma and biopharma industries worldwide are focusing on core competencies and outsource their packaging, as confirmed by Contract Pharma's 10th annual outsourcing survey. So what should you look for in a packaging partner?

How To Use QbD Software To Improve An Existing Identification Method
Article | Pfizer CentreOne Contract Manufacturing

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

The Criticality Of API CDMO Selection: Insights From A Client
Case Study | Thermo Fisher Scientific

4SC AG, a clinical-stage biopharmaceutical company partnered with Thermo Fisher Scientific Pharma Services, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, is leading toward commercial success.

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