Search results for " contract manufacturing"
Article
Contract Manufacturing Through the Years
How has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hold?
By Jim Miller
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Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Maximum Output Starts with Optimized Upstream Processing
Biopharmaceutical companies of all sizes have sought additional contract manufacturing capacity to free internal capacity, expedite process development and large-scale manufacture, and forge partnersh…
Article
Regulatory Challenges in the QbD Paradigm
The acceptability of risk by a firm may vary depending on whether it uses manufacturing sites within its network or contract manufacturing facilities. When contract facilities are used, a well-written…
Article
Modular Manufacturing Platforms for Biologics
Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) have traditionally viewed modular approaches as too expensive and, as a result, have been r…
Article
Being Thorough When Transferring Technology
During tech transfer, methods, skills, technologies, and importantly, knowledge is transferred from the drug developer to another site or group, often a contract manufacturing organization (CMO). It’s…
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
zli…
Article
Challenges and Trends in Biopharma Facility Design
It may also facilitate outsourcing of production to contract manufacturing organizations, which can, therefore, rapidly switch between customer projects and campaigns. Some contract manufacturing orga…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ole manufacturing chain, spanning from the suppliers of crucial raw materials to the fill/finish and contract manufacturing organizations (CMO), where applicable (Figure 2).
Figure…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …