Manufacturing

Continuous Biomanufacturing: A New Approach to Process Scale

The BioPhorum first-edition Technology Roadmap outlined a 10-year vision for therapeutic protein production in the biopharmaceutical industry (1). The roadmap describes multiple manufacturing scenarios ranging from large-scale (~20,000-L production) to small and agile, portable production facilities. It includes detailed analyses of the needs for the future in each of the following areas: Process technologies (2) Inline monitoring and real-time release (3) Automated facilities (4) Modular and mobile (5) Knowledge management (6) Supply partnership management (7). Since the 2017 publication of…

Biomanufacturing Scenarios: From the Biomanufacturing Technology Roadmap

Drug Substance Scenarios Given the complexity of the biopharmaceutical industry and the increasing diversity of products and companies, it is clear that there will be no “one size fits all” solution to biomanufacturing. Instead, we see a range of biomanufacturing scenarios playing out over the next 10 years. Five high-level scenarios were selected for drug substance manufacturing and two for drug product to cover the full spectrum of process and facility types. Each facility type is associated with a representative…

A Shift of Mindset: How Single-Use Systems Influence Bioprocess Engineering and Project Execution

In past decades, the focus in bioprocess engineering was on traditional stainless steel project management, which is highly dependent on established project schedules. Many milestones, tasks, and deliverables during basic and detailed design and execution were implemented in the same tried and tested way by engineering, suppliers, and biopharmaceutical companies. Making decisions was complicated by alignment with long lead items. With the introduction of single-use (SU) technologies, the transition in execution and optimization of project management only just has been…

Long RNA Synthesis Report

Long single-stranded RNA oligonucleotides are increasingly necessary for a variety of genomic pathway research and drug discovery studies. However synthesizing and purifying long RNAs can pose unique challenges due to their sequence composition, secondary structure, and applied modifications. Here we explore how Horizon Discovery is leveraging Dharmacon’s 20+ years of RNA synthesis experience to solve the challenges of long RNA oligo synthesis to address unmet research needs.

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production – Part 3: Best Practices for Supplier Selection, Qualification, and Validation to Ensure Supply Chain Security

Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Corporate members include plastic equipment suppliers, service providers, and users in the biopharmaceutical industry who share this mission. A key focus of BPSA’s core activities is to educate its members and others through sharing of information and development of best practice guides that help suppliers, users, and…

From Interest in Intensification to a Factory of the Future

Much has been published on improvements and advances in many individual technologies for biomanufacturing. If you take a comprehensive look at the field, however, you find overlap, muddling, and even contradiction about which particular processes or aspects of technological development should be designated properly as process intensification. Although the industry is addressing such distinct goals as improved manufacturing yield, product quality, and cost-effectiveness, the names of initiatives commonly applied to accomplish those goals overlap at best. Such ambiguity and lack…

An Integrated Bioprocess for Antibodies: From Harvest to Purified Bulk in Six Hours

Antibody production platform processes have been widely adopted in biomanufacturing, but many unit operations are not suitable for integration and automation. Here we describe the work of integrating unit operations by transforming a column operation to a more robust cassette format. We have selected a biomolecule-friendly buffer (phosphate) to eliminate, or delay, the performance of a circulating tangential flow ultrafiltration/diafiltration (UF/DF) operation, so the harvest-to-purified-bulk process can be integrated, resulting in a single, direct-flow operation, that reduces the batch process…

Making Downstream Processing Continuous and Robust: A Virtual Roundtable

Current biomanufacturing is driven to pursue continuous processing for cost reduction and increased productivity, especially for monoclonal antibody (MAb) production and manufacturing. Although many technologies are now available and have been implemented in biodevelopment, implementation for large-scale production is still in its infancy. In a lively roundtable discussion at the BPI West conference in Santa Clara, CA (11 March 2019), participants touched on a number of important issues still to be resolved and technologies that are still in need of…

Going Beyond the Simple Customer–Supplier Relationship: Ensuring a High-Quality Supply Chain Through Transparent Partnerships

Operating a successful global supply chain to deliver single-use systems (SUS) for utilization in the biopharmaceutical industry is complex.  In his insightful article, Claudio Catallo, Head of Global Supply Chain Management FMT at Sartorius Stedim Biotech, details the company’s intelligent approach to supply chain management and the models it uses. He also explains how expert teams and integration of digitalization across many sales, manufacturing, and distribution sites maintain the operational excellence required to support supply and demand in an ever-changing…

Critical Considerations for Fill–Finish Manufacturing: Demand to Increase Speed and Flexibility While Maintaining Sterility Spurs Adoption of Novel Technologies

The global market for biopharmaceuticals continues to grow at a rapid pace, with a 9.5% compound annual growth rate (CAGR) predicted over the next eight years. That translates into more than $500 billion in projected growth. So it is no surprise that biopharmaceutical manufacturers are investing heavily in new facilities, technologies, and pipelines for manufacturing drug products. Even so, the need to prevent contamination places stringent handling and packaging requirements on biomanufacturers. Sterilizing equipment often requires steam autoclaves and dry…