Newsletter | November 12, 2019

11.12.19 -- 5 Keys To Biopharma Launch Success

 

Greetings Cell & Gene readers,

 

Rapid changes in the biopharma industry are making it increasingly difficult to launch new products successfully. In this article, we review the five key levers for biopharma launch success and explain how they inform the creation of a high-performing product launch framework.

 

The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. Here is a due diligence checklist for leasing a biotech manufacturing facility.

 

Erin Harris, editor in chief
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Industry Insights
Digitization Of The Supply Chain: Challenges In Scaling Up Cell And Gene Therapy
White Paper | By Mucahit Agirtmis, Werum IT Solutions America, Inc.

This white paper discusses the unique biopharmaceutical supply chain challenges of cell and gene (C&G) therapy logistics and recommends forward-thinking solutions to address them. Successfully overcoming these logistics challenges is essential in order to scale up C&G therapies to treat large numbers of patients worldwide.

Automating Cell Therapy Manufacturing For Increased GMP Compliance And Consistency
Article | By Per Hammer and Linda Lemieux, GE Healthcare Life Sciences

Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.

Six Dosing And Safety Considerations In The Era Of Emerging Therapies
Article | By Peter Larson, M.D., Premier Research

Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies.

Ten Tips For Flow Cytometry Success
Article | Bio-Rad Laboratories, Inc.

Read these tips to help maximize cell separation and isolation and set you up for downstream processes, including cell sorting.

Process Development For Cell Therapy And Viral Gene Therapy
Webinar | MilliporeSigma Cell and Gene

Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. In this webinar we will discuss our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.

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