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BioPharm International-11-01-2018
BioPharm International
New Equipment Advances Biopharmaceutical Operations
November 01, 2018
Features
31
11
Recent equipment and updated product options offer improvement to a range of biopharmaceutical manufacturing tasks.
Innovation and Industry Strength Recognized at CPhI
November 01, 2018
From the Editor
31
11
Survey results and record attendance may show positive signs for established and emerging biopharma regions.
Scaling Up Novel Therapies
November 01, 2018
Cover Story
31
11
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
User Requirements Specifications–How Difficult Can It Be?
November 01, 2018
Ask the Expert
31
11
Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
The Criticality of Manufacturing Data
November 01, 2018
Features
31
11
Industry is searching for ways to deal with the criticality of ensuring data integrity.
Single-Use Bioprocessing Equipment Trends and Adoption by CMOs
November 01, 2018
Perspectives on Outsourcing
31
11
The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.
Using Multiple Techniques in Biosimilar Analysis
November 01, 2018
Features
31
11
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
Innovations in Prefilled Syringes for Biologic Drugs
November 01, 2018
Features
31
11
As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.
Media Requirements for Different Cell Sources
November 01, 2018
Features
31
11
This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.
Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)
November 01, 2018
Peer-Reviewed Research
31
11
The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
Impact of ATMP Manufacturing on Process Equipment and Facility Design
November 01, 2018
Features
31
11
Advanced therapy medicinal products pose unique manufacturing challenges that will require appropriate and thoughtful facility design and equipment.
BioPharm International, November 2018 Issue (PDF)
November 01, 2018
Issue PDF
31
11
Click the title above to open the BioPharm International November 2018 issue in an interactive PDF format.
FDA Promotes Complex Generics and Combination Products
October 19, 2018
Regulatory Beat
31
11
To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.