Efficient Integration of Single-Use Equipment During Capacity Expansion Projects

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”

Breakthrough Technologies in Cell and Viral Therapies

BPI West: Day 1 Recap

“The future disruption of therapeutic modalities is closer than we think.” – Uwe Gottschalk

In Track 3, Late Stage Process Development & Commercial Launch Preparation, for a standing room only crowd, the featured presentation was given by Uwe Gottschalk, Chief Scientific Officer at Lonza. This track was developed to help attendees learn best practices to apply new technologies used by industry leaders to mitigate risk, improve product quality and ensure regulatory compliance for promising biologics. This exciting presentation included discussions around; T-Cell based cancer treatments, an overview of allo vs. auto, the challenges in scaling of products, the need for automation, disruptive technology and much more.

Continue reading “Breakthrough Technologies in Cell and Viral Therapies”

The Recent Growth of Biotech Clusters Around the Globe

David Brindley, Senior Research Fellow at University of Oxford Department of Pediatrics comes from a very interesting background that covers both academia and industry. He joined us during Biotech Week Boston to discuss the relationship between academia and industry, what he identifies as the key regulatory challenges in both the US & Europe, and then finally he explores the recent growth of biotech clusters around the globe.

By design, there are a number of initiatives around that globe to create biotech clusters. “The two greatest biotech clusters in the world are undoubtedly the 128 corridor around Boston and Silicon Valley on the West Coast” Brindley says. However, he does mention that these clusters were development completely by accident, and not by design. Moving forward, as the growing of biotech cluster initiatives progress, these regional hubs need to focus/specialize on a very deep niche. If you are looking to set up a new cluster, Brindley says, “you should worry less about the platform technology it will develop,  is it monoclonal or is it small molecule. And [instead], focus more on ‘what is the bioprocessing problem that we are going to address here? Is this going to be a center of manufacturing?’ because I think even saying we are going to be a center of drug development is too broad.” This train of thought shows that collaboration is necessary for large-scale success of the industry.

Continue reading “The Recent Growth of Biotech Clusters Around the Globe”

Affordable Biologic Downstream Purification with Single-Use Protein A Membrane

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”

Downstream Processing Single-Use Technology

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”

Supplier Capabilities Underscore Their Value Creation Potential

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”

FDA First Generic Drug Approvals List 2017

Keeping up with all of the new first generic drug approvals can be a tricky business. On this page, we are dedicated to keeping the list updated and you informed.

(Updated 09/02/17)

27 January 2017 – Amneal Pharmaceuticals LLC, Namzaric (memantine and donepezil hydrochlorides)

 A first generic drug approval has been granted to Amneal Pharmaceuticals LLC to produce Namzaric for the treatment of moderate to severe dementia of the Alzheimer’s type.

Click here to find out more 

23 January 2017 – Actavis Laboratories FL, Inc. & Aurobindo Pharma Limited, Ampyra (Dalfampridine)

 For those suffering with multiple sclerosis (MS) the first generic drug approval for Ampyra has granted to help improve walking for the patients of the disease.

Click here to find out more

17 January 2017 – Roxane Laboratories Inc., Xyrem (Sodium Oxybate Oral Solution)

The first generic drug approval for Xyrem come to the aid of those suffering of cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy.

Click here to find out more

4 January 2017 -Aurobindo Pharma Limited,  Ampyra (Levitracetam in Sodium Chloride Injection)

This new FDA first generic drug approval granted to Aurobindo Pharma Limited for an anti-epileptic drug indicated for the adjunct therapy in adults >16 and 16 years of age with certain seizure types when oral administration is temporarily not feasible.

Click here to find out more