The Latest Advancements in Downstream Processing
As single-use technologies have grown in importance and acceptance, offering more solutions every year, their biggest challenges have come in downstream separation, purification, and processing that follows product expression in cell culture. Many technologies in downstream processing present technical and economic problems. Authors in this featured report delve into many of these issues and innovations. They discuss automation, depth filtration, continuous processing, alternatives to resin chromatography, and fill and finish technology.
Cell, Gene, and Tissue Therapies:
Solutions for Expansion, Purification, and Engineering
Cell therapy bioprocessing has advanced from limited efforts in specialized laboratories and academic institutions to becoming part of the mainstream biologics industry, with hundreds of companies involved and 20 product approvals in the United States (and more elsewhere). This featured report takes a snapshot of the processing issues of today — manufacturing platforms, purification of viral vectors for gene therapy, three-dimensional bioprinting — and looks toward the future of this biologics market segment.
Who, What, When, Where, and Why?
Biopharmaceutical outsourcing has changed over the years. In this Featured Report the authors explore the increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on both sides of the relationships; and the criticality of navigating the uncertainties of working with different quality organizations. Issues that affect decisions to outsource include cost, converging quality systems, change management, and staff training/expertise (including statistical capabilities).
Biosimilars: Tackling the
Technical and Regulatory Challenges
Biosimilar products have come about as a way to make biopharmaceuticals that are otherwise too costly available to a broader market. Like generic small-molecule drugs, they build on the success of licensed products. And although regulatory pathways allow biosimilar developers to bypass certain expensive testing, they are not generic drugs. Technical challenges remain a part of their development. This Featured Report contains an overview of those challenges and articles that dive into technologies that can help, regulatory hurdles that remain, and a look at the countries that are leading the way globally.
Continuous Processes: Disposables Integrate
Upstream and Downstream Processing
Perhaps the “hottest” buzzwords in biomanufacturing today are continuous processing and single-use technologies. They are closely related — as one is increasingly enabled by the other. Perfusion and other approaches have begun to blur the line between upstream and downstream processing (by performing certain separation/clarification duties as part of their function). And separations technology suppliers are offering solutions to the challenge of continuous drug-substance purification. Alongside a review of these advancements by BPI’s senior technical editor, contributed articles expand on continuous upstream/production methods and continuous downstream processing technologies.
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