‘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.
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”.
Continue reading “Developing Cell Therapy Manufacturing Processes”
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. 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.”
Continue reading “Applications of Single-Use/Disposable Technology in Fill/Finish [Whitepaper]”
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.
Continue reading “Manufacturing Biologics: Challenging & Expensive”
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”
What will patient-specific cell therapy manufacturing look like on a large scale?
Patient-specific cell therapies (PSCTs) are still very new, and all parties involved in the manufacture and sale of these innovative treatments are getting their heads wrapped around how the process will work. To get to the reality of large scale PSCTs, an evolution will need to occur.
In this article from PCT (a Caladrius Company), the authors examine how the industry can move from our current state, to the future of manufacturing these challenging therapeutics.
Continue reading “Patient Specific Cell Therapy Manufacturing – How Will it Work?”
While innovation and market demand have had a phenomenal impact on drug development, the manufacturing side has been somewhat slower in evolving to newer, more flexible and cost-effective technologies. However, there is a definite trend in transitioning legacy facilities and new facilities away from the traditional one product-one facility biomanufacturing model in order to capture market demand and produce multiple products in the same facility. So transformative technologies are being incorporated into new facilities as well as aging/legacy facilities with the goal of maximizing capacity and efficiency and also driving down costs.
In 2015, customers who had used single-use technologies for 10 years had significant cost benefits: 20-30% reduction in operating costs, 40-50% reduction in capital costs, and 30% reduction in time-to-build as compared to traditional stainless steel technology.  The cost benefits come from significantly reduced setup and switchover times providing flexibility for manufacturers to quickly change their product lines. Disposables require less maintenance, sterilization, clean steam, chemicals, and energy. 
Another highly cost effective transition that is gradually being implemented for portions of the manufacturing process is the switch from batch to continuous manufacturing. Continuous manufacturing saves money, time and space, with impressive advantages over batch processing.  Footprints are estimated to be 40-90 percent smaller, resulting in 20-76 percent lower capital expenditures as compared to batch systems. Other advantages include increased capacity for production, less maintenance and lower energy use. Also, there is less time required for scale-up from clinical to commercial scale production. 
Continue reading “[Whitepaper] Strategies for Creating Flexibility in New and Legacy Biomanufacturing Facilities”