Newsletter | March 23, 2020

03.23.20 -- 3 CMC Mistakes That Could Cost You Billions

 
Featured Editorial
3 CMC Mistakes That Could Cost You Billions
 
By Kevin Wall, principal consultant and owner, Cincero Consulting

The end game for many small biotech startups is acquisition by Big Pharma. How should small biotech companies prepare their chemistry, manufacturing, and controls (CMC) documentation for due diligence review? What are the mile markers that measure how far product and process have developed? While the CMC section may not add zeros to the sales price, poorly documented development can remove them.

Another "Partnership" Sob Story: A Dear John Letter To Biotech Landlords
By Herman F. Bozenhardt and Erich H. Bozenhardt

The “courtship” of a biotech tenant and a landlord often takes months, with negotiations over lease length and costs. Initially, the “romance” expects that the two parties will exist together for the long term; however, that is rare. Here's how to break off negotiations on the proposed lease and pursue other properties.

Industry Insights
Continuous Process Performance Enhancements For 50 L To 500 L Single- Use Bioreactors
Poster | By Ben Madsen, Jordan Cobia, and Nephi Jones, Thermo Fisher Scientific Bioproduction

This study demonstrates integration of the HyPerforma Single-Use Bioreactor (S.U.B.) and how strategic enhancements to the sparger and agitation systems have revealed potential improvements.

Does Selecting A CDMO Based On Contract Price Really Save You Money?
Article | Pfizer CentreOne Contract Manufacturing

Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

Prefilled Syringe Assembly: Ensuring Container Integrity
Case Study | Thermo Fisher Scientific

How a global pharmaceutical company developed an automated process for assembling prefilled syringes without compromising container integrity in a large molecule gastroenterology product.

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.

Solutions
In-Canada Clinical Trial Distribution
Ropack Pharma Solutions
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