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.

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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:

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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.

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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

Biopharmaceutical Fill and Finish [eBook]

15-1-january-ebookBecause 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:

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What Components are Introducing Risk in Aging Facilities?

At Biotech Week Boston, we sat down with Dr. Christopher Smalley, Senior Consultant at ValSource (formerly the Director of Global Technical Operations at Merck & Co.) for some exclusive insights into evaluating risk of components in aging facilities.

As the biopharmaceutical pipeline is becoming more complex, the industry is rethinking the traditional one product-one facility approach to manufacturing. This attempt to create flexible manufacturing facilities not only addresses the need for multiple products but also can accommodate market demand.

In this exclusive interview, Dr. Smalley addresses some of the major challenges and trends in the bioprocessing industry today;

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Direct Inoculum of Bioreactors with CHO Cells from Frozen Seed Bags to Eliminate Continual Seed Trains and Improve Facility Utilization

This article was originally published on www.CellCultureDish.com

By Brandy Sargent, Editor, Cell Culture Dish

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Flexibility in cell culture manufacturing via a reduction in process duration can be a key strategy for maximizing facility utilization and facilitating the production of multiple therapeutics from a facility. A key bottleneck is the seed train, which can add weeks to the timeline of the production culture. Seeding production bioreactors with a direct, cryopreserved CHO cell inoculum could possibly eliminate the need for a lengthy, continuous seed train and provide other numerous benefits.

At this year’s Boston Biotech Week, two feasibility studies were presented that showed the use of a Frozen Seed Bag (FSB) for direct cell inoculum into a production bioreactor. Shahid Rameez of KBI Biopharma and Nikhil Ramsubramaniam of Merck presented separate studies demonstrating the use of frozen inoculum in fed-batch production bioreactors (KBI) or perfusion bioreactors (Merck).

KBI described a current state-of-the-art production process consisting of scale up from spinner flasks, through a bag bioreactor into stirred tank bioreactors – a 5-week process (see Figure 1). According to the study results presented, implementation of a direct frozen inoculum approach could potentially reduce a 5-week timeline to as little as 1.5 – 2 weeks. Such an improvement could vastly increase the productivity of current cell culture manufacturing facilities.

Continue reading “Direct Inoculum of Bioreactors with CHO Cells from Frozen Seed Bags to Eliminate Continual Seed Trains and Improve Facility Utilization”