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.
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.
Continue reading “Biomanufacturing networks and the next generations of production facilities”
‘It’s amazing to think about the opportunity we create with other colleagues in the CAR-T field where we see patients who have no options – refractory tumour patients where a doctor tells them we cannot do anything else for you – we can come in with a new therapy.’ At Cell Therapy Manufacturing & Gene Therapy Congress we sat down with Markwin Velders, Vice President of Operations of Kite Pharma, to discuss the use of CAR-T therapies as a revolutionary treatment for populations of patients who were previously untreatable.
Vedlers is excited by recent breakthroughs in the use of CAR-T therapies in cancer patients and confident that they’ll continue. He emphasises patient populations, such as those with non-Hodgkinson Lymphoma, that can ‘now be treated effectively and can even reach 60-70% remission’, a group ‘who never had that option before’. He describes it as ‘an unmet medical need where we make a difference’, which offers a hopeful insight into the progress Kite Pharma are currently making in the field.
Kite has had success using immunotherapies to treat haematological, or liquid tumours, but Velders feel that it is in the much ‘wider field’ of solid tumours that they should be looking to make progress on current therapies. Solid tumours make up the largest number of cancer sufferers, and Velders hopes to ‘embark on the next phases’ for treatment ‘where there are real chances for the therapy as well as other opportunities’.
Continue reading “70% remission in previously untreatable cancers: CAR-T therapies with Markwin Velders, Kite Pharma”
‘What convinced investors, and what convinced our alliance partners were the clinical result we had in chronic lymphatic leukaemia, I think that’s important. I think with animal models, they are very helpful in a sense, in just the bare bones test system, but to prove efficacy, in the end is to run clinical trials.’ Jan Joseph Melenhorst, Director of Product Development & Correlative Sciences Laboratory from the University of Pennsylvania, discusses the necessary steps that must be taken for their cell therapy to become a viable treatment option.
Within his department at the university, Melenhorst examines the post infusion specimens of cells to better understand the potency and toxicity of the cells they infuse into patients. To enhance the potency of cells, additional gene editing tools can be included to modify the genome of the T-Cells and further enhance the expression of the targeting gene. Melenhorst speaks of his own experience with the CRISPR-Cas9 gene editing tool, but also draws upon the use of TALENs, stressing its importance to ‘the future of autologous and allogeneic cell therapies’. It is the autologous therapies Melenhorst believes are the current future of CAR-T therapy. Continue reading “Proving the efficacy of cell therapy treatments to convince investors”
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by Cheryl Scott, Senior Technical Editor, BioProcess International
At least one innovator company has embraced the concept of biosimilars wholeheartedly, calling it “our next chapter in healthcare” in a 2016 report. That publication cites product characterization, preclinical studies, nomenclature, reimbursement, and regulatory pathways as the primary challenges facing companies in biosimilar development. (Note: See Amgen’s 2017 biosimilars report here.) For our own featured report on biosimilars this month, we asked the contributors about those topics. The answers below come from Bruno Speder (head of clinical regulatory affairs at SGS) and Mario DiPaola (senior scientific director at Charles River Laboratories).
Product Characterization: What is the most challenging aspect of biosimilar characterization? How are companies obtaining originator samples to compare against?
SPEDER: One major challenge in developing biosimilars is to obtain sufficient originator product for characterization testing in both the preclinical and clinical development phases. The supply of originator product is very closely monitored by the manufacturers of those products because they seek to slow down the development of biosimilars. So this can be a difficult task. Originator product samples usually are obtained through specialized distributors.
Preclinical Studies: Can nonclinical/animal studies aid in supporting extrapolation of indications? Continue reading “Biosimilars: Technical and Regulatory Challenges Featured Report”
‘The Xuri Cell Expansion System W25…is heavily adopted within the T-Cell Expansion System which enables our customers to grow up significant doses of T-Cells in a functionally closed environment. We are working with our customers to further connect the Upstream and Downstream.’ George White, Commercial Leader of Cell Therapy from GE Healthcare, outlines the positive acquisitions they have recently made that will assist their customers in implementing successful cell therapy systems.
GE are currently looking to the future of T-Cell therapy technologies to develop harmonised partnerships that will facilitate and allow their customers to implement fully automated and integrated systems. White highlights the ‘amount of effort and resources [GE] put into developing protocol and applications, specifically for T-Cell manufacture,’ that lead to the close relationships they have with their customers who look for a ‘complete solution.’ Continue reading “How GE Healthcare are implementing new cell therapy technology to develop a fully automated and integrated system”
‘If one or two CAR-T therapies get to market it will provide impetus and momentum behind the industry’ – Dr Akshay Peer, Vice President of Sales and Account Management at TrakCel discusses the revolutionary steps that cell and gene therapies are making through their increased commercialisation.
In a field that is constantly seeing developments, Dr Peer outlines CRISPR and CAR-T therapies as forms of gene editing that can dramatically change the face of gene therapies and their use within modern medicine. He believes that as the commercialisation of these treatments increases, the regularity of their use will as well.
This is due to the surge in ‘positive public opinion’ that will arise from the successful implementation of the therapies. Dr Peer identifies the positivity that already exists around the new therapies, with ‘everyone looking at when these therapies will come to market and how much they will cost’. Although not going into detail about the financial outcome, he outlines his hope that when the public can see the lives of adults and children enhanced by using these therapies, any uncertain opinions will change to ones of optimism and confidence.
Peer acknowledges the lack of information that can exist around the new therapies due to an unfamiliarity in their usage; ‘People can sometimes get ahead of themselves and not understand completely what we’re trying to do here in this industry’. However, he is sure that this will change once there is evidence of patients who are successfully treated.
There is clearly excitement developing around the use of gene therapies, outlined by Dr Peer.
Watch the full interview, filmed at Cell Therapy Manufacturing & Gene Therapy Congress, with Dr Peer above or here.