Facility Design/Engineering

Streamlined Column-Packing Design for a New Commercial Launch Facility

To meet network demand for a commercial launch facility, Genentech (Roche) designed a new downstream train and built it within an existing building shell at the company’s Oceanside, CA, site. This downstream train included new technologies to allow for rapid technology transfer of different new products in the company’s drug pipeline. One technology that was pursued was the Axichrom column platform from GE Healthcare and associated column packing equipment to streamline column packing design. Here we focus on how a…

BioPhorum Operations Group Technology Roadmapping, Part 3: Enabling Technologies and Capabilities

Although great strides have been made over the past 20 years to increase the productivity and robustness of manufacturing processes for biopharmaceuticals, the cost and complexity of their development and manufacturing remain high, especially in comparison with those of small-molecule pharmaceuticals. Process improvements are required to increase patient access while maintaining the viability of an R&D-driven biopharmaceutical industry. Facility productivity, cost of goods (CoG), and capital investment all have significant margins for improvement. Such goals can be achieved not only…

BioPhorum Operations Group Technology Roadmapping, Part 2: Efficiency, Modularity, and Flexibility As Hallmarks for Future Key Technologies

For a complex biopharmaceutical industry, setting out to forecast future technologies must involve considering how such technologies will be used. In the first article (1), I discussed why there was a need to develop a technology roadmap for the biopharmaceutical industry and the trends shaping its future: namely, the introduction of new product classes, the continued growth of the biopharmaceutical market, pressure to reduce costs, and uncertainty in approval and sales of new products. Herein I discuss the technology roadmap’s…

Addressing the Challenges of Developing Biopharmaceutical Drugs

The biopharmaceutical industry is enjoying considerable success. Its products account for about a fifth of world pharmaceutical revenues, which are growing at twice the pace of those generated by most traditional chemically synthesized drugs. Biopharmaceuticals populate the list of best-selling drugs, and a number have achieved blockbuster status. Biotechnology stocks have outperformed the general market as investment has flowed into the industry. As with other highly profitable markets, the market for biopharmaceuticals has become increasingly competitive. Reflecting this fact, in…

A Single-Use, Clinical-Scale Filling System: From Design to Delivery

Single-use components have been successfully incorporated into many unit operations for both upstream and downstream processing, from laboratory scale to commercial manufacturing. The development of single-use filling needles has created an opportunity to introduce fully disposable systems into final formulation and filling of drug products (1). One major challenge in replacing a cleanable filling line containing stainless steel needles is to ensure that an alternative system can satisfy all critical performance parameters established for an existing process. In 2012, Merck…

Special Report on Continuous Bioprocessing: Upstream, Downstream, Ready for Prime Time?

Once an engineering curiosity and smallscale laboratory technique, continuous bioprocessing has evolved in just a few short years to a topic of intense and increasing interest to most bioprocessors. Critics point to a steep learning/adoption curve, but that is nothing new in biomanufacturing.Andrew Zydney is a distinguished professor of chemical engineering at Pennsylvania State University. He has noted these challenges facing continuous processing: commercially unproven unit operations (especially downstream), a lack of equipment robustness, sterility concerns, and uncertain development timelines…

Factories of the Future: Can Patient-Specific Cell Therapies Get There from Here?

In many ways, patient-specific cell therapies (PSCTs) are still the “new kid on the block” in medicine. Researchers, therapeutic developers, manufacturers, regulators, and payers are still exploring and developing an understanding of the powerful benefits and unique challenges associated with this growing industry. As we all become more familiar with PSCTs, an evolution will need to occur — as it has for automobiles, computers, and every technological advance in human history — for these therapies to become widely adopted, cost-efficient,…

Automation in Cell Therapy Manufacturing

The concept of automation conjures up images of robots on assembly lines or perhaps automobiles replacing horse-drawn carriages. In both examples, automation provides an ability to work tirelessly, with reproducible high-quality outputs at increased speed. For cell therapy, automation can be used to increase the scale of cell culture operations (e.g., bioreactors replacing flasks) and allow the use of closed systems that can protect cell products from contamination with adventitious agents from the environment or operators themselves. Closed systems also…

Insulin in Demand: Engineering a Facility to Serve Local and International Markets

Discovered in 1922 at the University of Toronto (by Frederick Banting and John James Rickard Macleod), insulin has been produced from animal extract, primarily cattle and pigs. Following Frederick Sanger’s work on insulin sequence in 1951, Dorothy Hogkin published in 1969 the three-dimensional structure of insulin. This breakthrough led to many developments and applications of recombinant DNA for the production of insulin, human first and then analogs. The significant increase in the diabetic population — especially in BRICS countries (Brazil,…

Advances in Bioprocessing: Single-Use and Stainless Steel Technologies

The increasing penetration of disposable devices in the biopharmaceutical manufacturing industry has been well documented, and with good reason. These applications represent a new paradigm in the evolution of biomanufacturing technologies and practices, opening the industry up to new possibilities such as flexible and modular facilities. But stainless steel applications and innovations remain vital to this industry. Some stainless devices may be irreplaceable, including large tanks, autoclavable and heat-sterilized fermentors and bioreactors, and storage and filling devices. Other innovations in…