Who are the competent biomanufacturers?

by Nick Hutchinson

Once upon a time, this seemed like a very easy question to answer. Engineering companies designed facilities with stainless steel equipment to the user requirement specifications of their biomanufacturing customers. These biotech companies then operated the facilities, producing quantities of product to supply the market. They understood these products, having developed them in-house, and had designed, characterized and scaled-up the required bioprocess. They put in place the quality systems necessary to ensure the safety of their patients. In short, these biopharma companies were vertically integrated with competencies in developing, producing and marketing their products in a tightly regulated market. To better serve their customers they invested in manufacturing sciences leading to process innovations that lowered costs, increased throughput and improved product quality.

Leading biopharmaceutical firms still see biomanufacturing as a core competence. Amgen, to give one example, proudly states in its 2016 Annual Report that the company’s “long record of delivering reliable supplies of high-quality medicines with improving efficiency is a source of differentiated competitive advantage”.

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Biomanufacturing networks and the next generations of production facilities

by Nick Hutchinson

Last month, speakers from UCB Pharma, Biogen Inc and Amgen were describing next generation processes development – platforms, products and plants during the opening plenary session of the BioProcess International European Summit. The industry, it would appear, is continuing to evolve its approach to manufacturing operations in response to changing market conditions and innovations in production technologies.

In the past, monoclonal antibodies typically made up a significant proportion of company’s pipelines. Recently, however, these pipelines have become more diverse and so the manufacturing networks of large biopharma companies need to be “modality agnostic”. This diversity extends beyond just the type of molecule being produced but also extends into the dosing regime, such that drug product facilities must be suitably adaptable.

Market Uncertainty

Increasing drug potencies and specificities are leading to a downwards trend in the production volume requirements for a given product. However, at the same time, products are nowadays expected to be supplied to global markets rather than a handful of geographical regions. Uncertainly in forecasted demand is growing as firms extend their reach into previously unchartered markets and the industry become more competitive. Biopharmaceutical companies are placing greater emphasis on developing agile manufacturing networks and larger firms see operations functions as a key value driver to be integrated into corporate goals.

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Sourcing raw materials for cell therapy manufacture – Dieter Hauwaerts, Celyad

‘Start working on raw materials early on’ – for Dieter Hauwaerts, Vice President of Operations at Celyad, the way to combat one of the biggest challenges in cell therapy manufacture is clear.

Limited availability of raw materials is a major issue for large scale manufacture of new therapies, but planning well in advance can help mitigate it: ‘In process development, take into account the quantity and quality of raw materials you will need in a clinical stage or commercial manufacturing process and build good relationships with suppliers.’

However, even with the necessary raw materials, Hauwaerts still sees issues with ‘the way we can manufacture products in a reliable and consistent way’, though he hopes that in 2017 automation will begin to negate this.

Watch the full exclusive interview with Hauwaerts – filmed at Cell Therapy Manufacturing & Gene Therapy Congress 2016 – above or here.

Developing Cell Therapy Manufacturing Processes

As a lead in to the upcoming Cell & Gene Therapy Bioprocessing & Commercialization conference this October, members of the expert speaking faculty have been kind enough to join the KNect365 Bioprocessing team to discuss hot topics, key innovations, major disruptors and more across the industry.

In today’s volume, Ravi Bhatia, Scientific Director, PDMS at Janssen R&D discusses his start in the cell therapy industry, collaboration and innovative thinking to solve process challenges, autologous CAR-T products, the manufacturing process, and the upcoming conference where he will be presenting a session titled, “Scale-Up of an Allogeneic Cell Therapy Product”.

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Applications of Single-Use/Disposable Technology in Fill/Finish [Whitepaper]

Whitepaper Overview:

A range of factors are currently conspiring to push the field of pharmaceutical manufacturing toward wider use of SUSs. While factors specific to the fill/finish stage have meant that it has taken the longest to be affected by such changes, recent developments in the associated materials, technology and regulatory landscape are making possible rapid development on this front. Disposables have the potential to render substantial benefits in respect of savings of time and expense, and enhancements to safety and clinical rigor. All this makes it almost certain that they will see continued growth in the immediate future, and anyone with a stake in the industry would do well to keep a finger on the pulse of this transformation.

The CMO Patheon has installed an entirely disposable fill/finish system that is fully validated, scalable from 2 liters to 200 liters, and meets all requirements in respect of E&Ls.[1] Fill sets of three different sizes were manufactured in collaboration with suppliers. An initial saving of 10% on capital investment was achieved through the implementation of a single-use system, and subsequent continuing benefits include a reduction in personnel hours required for changeover from 19 hours to 1.5. Further, the flexibility offered by SUSs in terms of size means that excess or wasted capacity is greatly reduced, and Tony Pidgeon, senior manager of global science and technology at Patheon, claims, “At this point, whenever we can, we will opt for single-use systems, and single-use technology has become the preferred approach for new facilities.”[1]

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Manufacturing Biologics: Challenging & Expensive

Suresh Choudhary, Associate Scientist II of Formulation Sciences at MedImmune will be joining the speaking faculty at the upcoming Bioprocess Internation Conference & Exposition this October in Boston, MA. Suresh was kind enough to sit down with the KNect365 Bioprocessing team to discuss the challenges associated with manufacturing biologics and other current trends he sees as important in the industry.

He began by addressing the topic holistically and said, “Manufacturing biologics is very challenging and expensive.” but continued on to note that the driving force behind all of this is getting to market as quickly as possible.

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The Future of Cell Therapy Manufacturing

By Brian Hampson, Vice President of Global Manufacturing Sciences and Technology, PCT

Patient-specific cell therapies (PSCTs—those in which cells extracted from the patient or a donor matched to the patient are processed and then returned as therapy to the patient) are still, in many ways, the new kid on the block in medicine; researchers, therapeutic developers, manufacturers, FDA, and payers are still exploring and developing an understanding of the powerful benefits and unique challenges of this growing industry. As we all become more familiar, an evolution will need to occur—as it had to for automobiles, computers, and every technological advance in human history—in order for these therapies to become widely adopted, cost-efficient, market-scalable, and sustainable over the long-term. We must seek to understand what is needed from a manufacturing perspective for us to achieve the future of patient-specific cell therapy. Continue reading “The Future of Cell Therapy Manufacturing”