Facility Design/Engineering

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…

Meeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering Challenge

Classical stainless steel installations in purpose-built facilities dominate the global capacity for commercial biopharmaceutical manufacturing. Early facilities that were designed for single-product processes are now aging, putting them on the investment radar for upgrades to enable manufacturing diversity, and allow more efficient facility use. More than ever before, global engineering leaders are confronted with complex strategic and financial decisions when they seek to invest capital in new flexible pharmaceutical facilities or flex-grading aging facilities for supply of pipeline products. Manufacturing…

Single-Use and Stainless Steel Technologies: Comparison, Contrast — Where Are They Going?

At a recent conference, there was much talk about a major biopharmaceutical project in Asia for which the owner of a company chose a design with primarily traditional multiuse stainless steel tanks and processing equipment, rather than single-use polymer equipment. There were even some stainless steel equipment vendors toasting at the bar that this may be the beginning of a “renaissance” of stainless steel. Is the single-use systems (SUS) honeymoon over? Are many industry professionals hoping this is the end…

Implementing Flexible, Scalable, and Cost-Efficient Bioprocess Platforms: A Proven Project Management Approach

Although significant scientific progress has been made in the biotechnology industry, it has lagged behind other sectors — such as aviation and automotive — in developing, scaling up, and industrializing products coming out of R&D. The goal is to implement robust and reliable manufacturing processes for good manufacturing practice (GMP) market supply cost-effectively. But manufacturing methods for biologics have remained unchanged for decades, with large-scale, capital-intensive stainless steel facilities taking three to five years to build and remaining both energy…

Recruiting and Market Share Reshape Life Sciences Facilities and Locations

Where a biopharmaceutical company does business affects its profitability — as does how it manages its facilities and even where its non–customer-facing operations are located. In fact, facilities and real estate represent some of the biggest expenses for such companies. And yet, they are often overlooked. In today’s shifting global life-sciences landscape, site selection and management strategies are coming to the forefront as companies seek operating efficiencies, access to multidisciplinary talent, and cost-effective facilities. The following insights from JLL’s 2014…

Modern Laboratory Design: Creating a Space for Effective Collaboration

When asked to envision a modern biotechnology laboratory, lay persons might describe what they’ve seen on an episode of CSI: Miami. Gleaming glass and striking colored lights might look good on television, but they are not what biological researchers need to do their work most effectively. Most of the real biological laboratories I’ve visited, in fact, have been stark, white, fluorescent-lit environments that more resemble something out of 2001: A Space Odyssey. But those are becoming passé. The newest concepts…

Build, Buy . . . or “Rent” Capacity? A New GMP Biomanufacturing Business Model

When it’s time to move from preclinical to clinical-phase product testing, many biopharmaceutical companies face a difficult decision: whether to build or buy a biomanufacturing facility for in-house production or outsource the work to a contract manufacturing organization (CMO). Accinov is a new company that straddles the line between those concepts. Its new biomanufacturing center supports client companies toward clinical development in an innovative way. We propose a groundbreaking model for running good manufacturing practice (GMP) biomanufacturing. Our company’s approach…