Newsletter | July 10, 2019

07.10.19 -- Maintenance 4.0: The Next Revolution In Biopharma Manufacturing

Featured Editorial
Maintenance 4.0: The Next Revolution In Biopharma Manufacturing
By Tobias Kuners of Koenders, managing consultant, Tob Management

Maintenance 4.0 does not arrive at your facility’s doorstep. It needs to be planned, organized, and executed. Learn how to influence the maintenance department and its stakeholders toward Maintenance 4.0 in your organization.

Transform Therapy Supply Chains Into Patient-Connected Value Chains
By Sanjay Srivastava, Laks Pernenkil, and Hussain Mooraj, Deloitte

Traditional supply chain management does not necessarily create patient value in emerging therapy value chains. Operations should be the backbone of a distribution model that delivers these products efficiently and effectively over the last few yards.

Industry Insights
Key Design Elements For A Highly Potent Lyophilized Drug
White Paper | By Jeff Tremain and Ted Tharp, AbbVie

Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.

How To Overcome Validation Challenges In A Single-Use World
White Paper | CPC

How can end users ensure the expected level of compliance in this new world of single-use systems? The secret: shared responsibility for validation with your supply chain.

Collegium Pharmaceutical’s Innovative Approach To Abuse Deterrence
Case Study | Thermo Fisher Scientific

To address the ongoing public health crisis related to opioid abuse, Xtampza ER has been developed to resist the ability of abusers to tamper with the product and alter the route of administration.

Speed Biologics To Clinical Trials Faster
E-Book | GE Healthcare Life Sciences

If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed-to-market.

The Challenges Of Biopharmaceutical Quality
Q&A | Samsung BioLogics

More than ever, the quality functions in biopharma manufacturing are under pressure. That pressure is unlikely to be relieved any time soon due to a global market rife with complex quality standards.

Exploring The Benefits Of Modular Chromatography Technology
Application Note | JSR Life Sciences

This application note details bed integrity testing of some resins recently packed in Chromassette devices prior to shipment to end users.

Challenges And Opportunities In The Development Of Biologic Drugs
Webinar | Dassault Systemes Americas

With transformational changes in biologics, there are increasingly newer formats of new biologic drugs including bispecific antibodies, antibody drug conjugates, and antibody-peptide fusion proteins.

Serological Pipets: Easypet 3
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