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Pfizer pumps $500m into NC gene therapy site

The expansion in North Carolina will create 300 jobs and is the latest investment by Pfizer in its burgeoning gene therapy network. The $500 million (€450 million) investment in Sanford, North Carolina will see the Big Pharma firm construct a facility to support production of its recombinant adeno-associated virus (rAAV) vectors for use in its gene therapies and vaccines. Mike McDermott, president of Pfizer Global Supply, said the Sanford expansion will “strengthen Pfizer’s leadership in gene therapy manufacturing technology” and…

Supply Chain Solutions for Cell and Gene Therapy Companies

Stakeholders across the supply chain stress that quality of starting material will be key to the success of cell and gene therapies. This is a topic that has created issues in the past, is puzzling the industry presently, and is likely to cause more problems going forward. This topic was front and center at the 2019 Phacilitate Leaders World and World Stem Cell Summit in Miami FL, with presentations focusing on supply chain solutions to address these complex challenges; cell…

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…

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.

Good Manufacturing Practice in China: Equipment Strategy and Quality Management to Compete with the West

Although the concept of good manufacturing practice (GMP) was created about half a century ago in the United States, the history of GMP biomanufacturing is relatively short in China, with the first version of GMP rules issued by the Ministry of Health in 1998. In 2010, the ministry issued its fourth version of China’s GMP rules, which came into effect in March of 2011 (1). According to a recent report from BioPlan Associates, the 2010 version raised the standards to…

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…

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…