BioPharm International-09-01-2018

BioPharm International

FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies

September 01, 2018

Regulatory Beat

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More consistent and reliable production processes are critical for advancing innovative treatments.

Characterizing Critical Quality Attributes in Biopharmaceutical Drug Development

September 01, 2018

Features

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Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.

Automated Single-Use System for Filtration and Product Dispensing

September 01, 2018

Product Spotlight

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The SciLog SciPure FD System from Parker Bioscience is an automated single-use system for the filtration and dispensing of products into either bottles or bags.

Lightweight Actuator for Aseptic Valves

September 01, 2018

Product Spotlight

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Watson-Marlow Fluid Technology Group added a new actuator suitable for applications where reduced weight is a concern.

Be a Part of the Solution

September 01, 2018

From the Editor

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Sharing of bioprocessing know-how can help resolve pressing industry problems.

Evaluating the Rewards vs. the Risks of Automation

September 01, 2018

Cover Story

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Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.

Checking Incoming Goods

September 01, 2018

Ask the Expert

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Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.

Biopharma Demand Continues to Influence CMO Actions

September 01, 2018

Perspectives on Outsourcing

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Partnerships, mergers, and new services indicate that biologics are continuing to influence CMOs’ and CDMOs’ decisions to expand their biopharmaceutical services.

QbD in the Development of ADCs with PBD Dimer Warheads

September 01, 2018

Features

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The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.

Patenting Antibodies in Europe

September 01, 2018

Features

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Although there are some similarities between the way that US and European authorities uphold antibody patents, there are also some important differences.

Elements in Raw Materials May Impact Product Quality

September 01, 2018

Features

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Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.

Ensuring Viral Safety of Viral Vaccines and Vectors

September 01, 2018

Features

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Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

September 01, 2018

Peer-Reviewed Research

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This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.

USP Proposes a New Chapter for Rapid Sterility Testing

September 01, 2018

Features

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The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.

BioPharm International, September 2018 Issue (PDF)

September 01, 2018

Issue PDF

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Click the title above to open the BioPharm International September 2018 issue in an interactive PDF format.