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.

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Affordable Breakthrough Therapies

An Interview with Denis Bedoret of MaSTherCell

We recently sat down with Denis Bedoret, Chief BD Officier at MaSTherCell in Amsterdam at the Cell Therapy Manufacturing & Gene Therapy Congress conference to discuss the critical issues and opportunities present in the cell & gene therapy industry today.

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Novel Strategies for Gene and Cell Therapies

By Manuel J. T. Carrondo, Prof. Chem & Biochem Eng., FCT/UNL & Vice-president, iBET

Since the early nineties iBET has been involved in production and purification of viruses for gene therapy. Early on, enveloped retroviruses and non-enveloped adenoviruses where the targets; from late nineties onward lentivirus and baculovirus were added to the portfolio of enveloped viruses and AAV to the non enveloped viruses.

Although originally meant for monogenetic diseases, now some are also produced for cancer treatment (ex. oncolytic adenoviruses made in A547 cells, so replicative) or as reagents for cell therapies (also known as ex-vivo gene therapies).

Having developed scaled down tests and analyticals (including surface plasmom resonance, dynamic light scattering) coupled with its chemical engineering model competencies, iBET has designed membrane or media materials for which our key partners MERCK Millipore, SARTORIUS, GE HealthCare have developed the prototypes tested on our biologies and equipments. In this way, improved DSP processes have been created increasing viral yields and infective to total particle ratios or yields and viability for cell therapies.

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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.

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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.

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How to Overcome the Funding Gap for Biotech Start-Ups

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.

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Cell Therapy Manufacturing and Gene Therapy Digital Week

27-30 March, 2017

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.

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