Search results for " start-ups"
Article
Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
sdecoret/Stock.Adobe.com
Pr…
Article
Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
unlimit3d/Stock.Adobe.com
Biomanufacturing proc…
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.
Jun 01, 2015
By Cynthia A. Challener
BioPharm Inte…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
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