By Nick Hutchinson
More than ever before, biopharmaceutical companies are able to establish their own in-house biomanufacturing capabilities. The adoption of single-use technology has reduced the need for expensive utilities systems and large manufacturing footprints. The inherent flexibility of this technology is allowing firms to connect steps in the production process with relative ease and without the need for fixed stainless steel pipework. Upfront capital costs have diminished and although operating costs remain, they are incurred only when the success of a drug candidate or licensed product warrants further production. Thus, single-use technologies provide a means to mitigate the risk of wasting large capital expenditures in the event a molecule is unsuccessful in the clinic or on the market.
Good engineering practices are key
Single-use technology is available for nearly every step in a biopharmaceutical manufacturing process below a certain scale of production. Biologics such as monoclonal antibodies and viral vaccines can be produced using processes in which the entire product, media and buffer flow-paths are disposable. However, companies attempting to install or expand new biomanufacturing capacity should be mindful that they should follow good engineering practices to maximize the probability of success. Despite the ease with which firms can install single-use capacity, relative to traditional stainless steel projects, this can nevertheless lead to an insufficient consideration of how firms should integrate single-use equipment with other steps in the process chain. The overlooking of proper integration can lead to incorrect equipment sizing, poor equipment design or an incomplete solution being developed. This can result in process failures, delays and the need to perform costly engineering rework.
Continue reading “Efficient Integration of Single-Use Equipment During Capacity Expansion Projects”
At Biotech Week Boston, we sat down with Tyler Merkeley, Health Scientist, Head of Special Projects & Portfolio Management at BARDA for an exclusive interview. He was also a panelist on the discussion on “How to Overcome the Funding Gap for Biotech Start-ups and Emerging Companies“.
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services office responsible for procurement and development of countermeasures principally against bioterrorism, but also including chemical, nuclear and radiological threats. Naturally, they are responsible for a national preparedness for pandemic and emerging threats.
Continue reading “How to Overcome the Funding Gap for Biotech Start-Ups”
KNect365 is pleased to introduce a special Digital Week program, comprised of a week-long series of free webinars with live Q&A – connecting cell and gene therapy leaders throughout the year from the comfort of your desk.
Cell Therapy Manufacturing & Gene Therapy Digital Week connects cell and gene therapy leaders to drive manufacturing and commercialisation through direct access to innovative discovery, product development, and regulatory know-how.
Register now to watch free educational sessions presented by leading industry experts, get answers to your toughest questions, network with colleagues and partners, and download useful resources.
Continue reading “Cell Therapy Manufacturing and Gene Therapy Digital Week”
This article was originally published on www.DownstreamColumn.com by Brandy Sargent, Editor in Chief
At this year’s Biotech Week Boston there were many exciting talks on downstream purification and associated new technologies. In particular, there were several talks about optimizing the downstream purification process. One very interesting talk, given by Renaud Jacquemart, PhD Principal Scientist, Director Vaccines Process Sciences, was titled “Enabling Manufacturing Of Affordable Biologics Through The Use Of A Protein A Membrane
In A Single-Use Purification Strategy ” and focused on the application of a fully single-use chromatography purification process in place of resins. This strategy envisions the use of a unique Protein A membrane for which Natrix recently signed collaboration agreements with Merck & Co. and Sanofi.
Creating a more affordable purification strategy
In his talk, Dr. Jacquemart begins by talking about the goal of creating a more affordable purification strategy and how the Natrix approach incorporates a holistic vision of the entire manufacturing process. To meaningfully decrease total cost and create the most efficient process, companies must significantly reduce the physical scale of manufacturing facilities and enable greater flexibility. This permits faster turnaround and accommodates a wider range of scales and products for any given time period. Achieving these goals requires a large increase in productivity and much-simplified single-use architecture for purification.
Continue reading “Affordable Biologic Downstream Purification with Single-Use Protein A Membrane”
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. BioProcess International magazine has produced a featured report that delves into many of these issues and innovations. They discuss automation, depth filtration, continuous processing, alternatives to resin chromatography, and fill and finish technology.
In the drive for reduced costs and more economical manufacturing of biopharmaceuticals, alternatives to resin chromatography are being examined. One article in the featured report focuses on the use of membrane adsorbers. Here, we provide an excerpt of Membrane Adsorbers, Columns: Single-Use Alternatives to Resin Chromatography:
Continue reading “Downstream Processing Single-Use Technology”
By Dr. Nick Hutchinson
The introduction of single-use technologies into biomanufacturing process increasingly requires the industry to operate as a cohesive network of organizations that function across all levels of the supply chain to ensure the safe and efficient production of biopharmaceuticals.
Biomanufacturers engage in a variety of activities that require them to work with suppliers ranging from the replacement of existing production equipment in established processes through to the development, manufacture and introduction of innovative, new-to-world biologics products. The nature of these projects influences the type of relationship that biomanufacturers will seek from their suppliers
KE Kristian Möller and Pekka Törrönen, working at the Helsinki School of Economic and Business Administration, published an article describing a spectrum on which a business’ projects may sit (Möller & Pekka, 2003). At one end of the spectrum lie projects in which firms are attempting to gain maximum efficiency from existing resources and technology and require a low level of relational complexity with their suppliers. At the opposite end of the spectrum are those future-orientated partnerships in which actors in the network co-create value and can lead to radical innovations that open up new business opportunities.
Continue reading “Supplier Capabilities Underscore Their Value Creation Potential”
Because they occur after two highly engineering, and science-driven phases of biomanufacturing – expression and purification – biopharmaceutical fill and finish processes have not received the respect traditionally that they deserve. Yet of all competencies associated with bringing biopharmaceuticals to market, fill and finish arguably are the most specialized.
This eBook reports on the technical and operating challenges impacting the latest formulations and devices including: outsourcing, contamination, standardization (pre-filled syringes), lyophilization, and serialization.
Here is an excerpt:
Continue reading “Biopharmaceutical Fill and Finish [eBook]”