Drug Product Fill and Finish: Challenges, Concerns, Compliance, and New Opportunities
Mainly based on the Drug Products track at the 2017 “BioProcess International Conference and Exhibition” in Boston, this report also includes a submitted case study and discussions from users and suppliers of fill–finish technology. BPI’s senior technical editor reports on the conference track. Presentations focused on predictive modeling, quality by design and process analytics, freezing–thawing and storage, endotoxin control, single-use technologies, analytics, and formulation. In addition, a new Pfizer case study examines single-use solutions for freeze–thaw of a vaccine. And experts address serialization, anticounterfeiting, and streamlining fill–finish operations.
Bioprocess Monitoring and Control: Leveraging Advanced Automation, Sensors, and Software
The need for advanced control strategies for bioprocessing and biomanufacturing is growing, and several manufacturers already have leveraged new automation and software solutions for bioprocess monitoring and control. In this Featured Report, authors discuss new approaches for process control that make use of increased computational power; advanced sensors, probes, and sampling technologies; and new software systems that can be applied to a wide range of operational modes (e.g., perfusion, continuous, and multicolumn platforms). Such technologies can be applied with single-use systems and within PAT and “machine learning” applications.
Bioprocess Training: Strengthening Preparation for Biopharmaceutical Careers
This featured report continues BPI’s annual focus on biomaufacturing training by introducing some programs through which industry and academia are extending science to the production floor. After an introduction from NC State University’s Biomanufacturing Training and Education Center, articles from the United Kingdom (University College London) and the Netherlands (the Biotech Training Facility) describe two different approaches. The final article describes a collaborative program driven by a US government initiative that brings together many different perspectives from industry, academia, and beyond.
Emerging Therapies: Processing First-in-Class Biologics
According to a 2017 industry report, 74% of biopharmaceuticals currently in development (phase 1–3) are possible first-in-class medicines. They include regenerative medicines, conjugated monoclonal antibodies (MAbs), and DNA and RNA therapeutics. Some emerging therapies — such as antibody–drug conjugates (ADCs) and biobetters — have been more at the forefront of discussions than others, but all are poised to bring exciting changes to patient care. Authors and experts in this Featured Report discuss how meeting and optimizing specific process needs for those products will be imperative to keep pace with innovation.
BPI Theater @ BIO 2017
The 2017 BPI Theater @ BIO took place June 20-22 in San Diego CA and focused on two main themes: emerging therapies and emerging technologies. The BPI Theater provides convention attendees working and interested in biopharmaceutical research, development and manufacturing with a dedicated destination to meet, network, and experience the latest science and technology trends impacting bioprocessing. Summaries of the presentations were included in the July-August Featured Report, and full video presentations are available for on-demand viewing.
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.
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.
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).
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.
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.
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