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November 2018
Volume 31, No. 11

| COVER STORY |

Scaling Up Novel Therapies

Agnes Shanley

Platform processes have improved monoclonal antibody scale-up. Can they improve personalized therapies?
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| UPSTREAM PROCESSING |

Media Requirements for Different Cell Sources

Feliza Mirasol

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.
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| DOWNSTREAM PROCESSING |

The Criticality of Manufacturing Data

Susan Haigney

Industry is searching for ways to deal with the criticality of ensuring data integrity.
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BioPharm International November Issue

Process Development Forum
Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com.
Click here to access the site ››

| PEER-REVIEWED |

Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)

Ronan McCarthy, Nick Hutchinson, Isabelle Uettwiller, Amélie Boulais, François Coutard, Eve DePauw, Ludovic Bouchez

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.
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| CELL AND GENE THERAPIES |

Can QRM Transform Biopharmaceutical Operational and Quality Culture Excellence?

José C. Menezes

Applied throughout a product's lifecycle and across a company's portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
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| ANALYTICS |

Using Multiple Techniques in Biosimilar Analysis

Rebecca Strawn

Application of multiple techniques at different conditions presents a complete picture of a dynamic situation.
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| OPERATIONS |

New Equipment Advances Biopharmaceutical Operations

Amber Lowry

Recent equipment and updated product options offer improvement to a range of biopharmaceutical manufacturing tasks.
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| PREFILLED SYRINGES |

Innovations in Prefilled Syringes for Biologic Drugs

Feliza Mirasol

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.
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IVT's 6^th Annual Laboratory Week
IVT's 6^th Lab Week conference series draws over 100 laboratory professionals and provides the value of three conferences in one, giving your team the ability to select sessions that best meet your business objectives. Hear from FDA and choose from over 25 workshops, think tanks, interactive presentations, case studies and educational courses surrounding analytical procedures and methods validation, stability testing and lab data integrity.
Learn More ››

| FROM THE EDITOR |

Innovation and Industry Strength Recognized at CPhI

Rita C. Peters

Survey results and record attendance may show positive signs for established and emerging biopharma regions.
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| REGULATORY BEAT |

FDA Promotes Complex Generics and Combination Products

Jill Wechsler

To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.
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| PERSPECTIVES ON OUTSOURCING |

Single-Use Bioprocessing Equipment Trends and Adoption by CMOs

Ronald A. Rader, Eric Langer

The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.
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| ASK THE EXPERT |

User Requirements Specifications–How Difficult Can It Be?

Siegfried Schmitt

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
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