Newsletter | October 9, 2019

10.09.19 -- Outsourcing Equilibriums And Imbalances

From The Editor
Outsourcing Equilibriums And Imbalances
By Louis Garguilo, Chief Editor, Outsourced Pharma

When it comes to outsourcing drug development and manufacturing, while some areas may be reaching a "saturation point" of sorts – a point where a higher percentage of outsourcing can or will not be attained – other areas are in need of a vital ramp up just to keep up. 

No Freeze In Lyophilization Outsourcing
By Louis Garguilo, Chief Editor, Outsourced Pharma

Ionis Pharmaceuticals considers itself a research and development engine  – and why not, with three commercial drugs and a pipeline of 40-plus clinic-worthy drug candidates. "We don't want to be a large-scale commercial manufacturer,” explains Max Moore, Executive Director, Manufacturing & Operations.  Instead, Ionis relies on CDMOs for that work, which almost always requires lyophilization. And so might your future product development and manufacture.

Featured Editorial
7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing
By Mujtaba Ali, managing director, OCQ Solutions

Any company with successful Phase 1 study data must ensure sufficient and consistent supply of drug product for possible Phase 2 and Phase 3 trials. For this reason, Phase 1 companies planning to outsource manufacturing of their clinical supply should take some essential steps early in the clinical manufacturing campaign to assure a timely and reliable supply of material throughout their clinical trials.

Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
By Bikash Chatterjee, president and chief science officer, Pharmatech Associates

One of pharma’s greatest foibles as an industry has been the penchant to focus on the wrong things. We saw this with process analytical technology (PAT), where we focused on the design and implementation of the technology and ignored the impact of foundational material characterization and supplier control. Pharma 4.0 has the potential to fall into the same trap.

Industry Insights
Best Practices For A Successful Bioprocess Technology Transfer
Article | GE Healthcare Life Sciences

A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time troubleshooting and you may delay your time-to-market. In today’s global markets effective tech transfer is critical.

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry
Webinar | By Aryo A. Nikopour, Nitto Avecia Pharma Services

This presentation discusses the basic definitions of extractables and leachables, including details from a case study done using prefilled syringes and a second using a single-use bag.

Direct-To-Representative Sample Distribution Services
Case Study | Thermo Fisher Scientific

Pharmaceutical manufacturers use a range of marketing channels to promote their prescription drug product. One proven and particularly effective approach is to have pharmaceutical sales representatives hand carry samples to the healthcare practitioners within their territories.

ÄKTA Readyflux Single-Use Filtration System
GE Healthcare Life Sciences
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