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Pharma IQ spoke to Dr Ryan Guest, Director of Cell Production from cell therapy manufacturer Cellular Therapeutics to explore the raft of emerging trends connected to cell and gene manufacturing.

In this interview Pharma IQ speak to James Sherley to find out what have been the major advancements in using stem cells for toxicology testing and the current challenges that need to be overcome in using stem cells for toxicology. In this interview you will also find out what are going to be the trends in using stem cells for toxicology over the coming 18 months.

Pharma IQ has created an easy-to-digest overview of biomanufacturing activity and spend around the world, whether they are already being implemented or have plans in the near future. You’ll be able to keep it as a handy reference, share it around your colleagues or even stick it on your wall!

When introducing a regenerative medicine cell based product to a commercial setting, there are a number of things to take into consideration to ensure a commercially viable and safe product for patient use. In this Q&A interview, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some great insights into the commercial manufacturing scale-up process of cell therapies.

Magda Papadaki, Head of Manufacturing Innovation, The Association of the British Pharmaceutical Industry (ABPI) shares her presentation from last year's Cell & Gene Therapy Manufacturing Forum: 'Identify the Opportunities and Challenges in Advanced Therapy Manufacturing Process (ATMP)'.

In this presentation:

• Determine what to consider when moving from research to commercial production
• Understand what different set backs will become apparent when looking at cost efficiency of manufacturing 
• Hear the recommended actions that need to be considered when in the positions of discovery and development of advanced therapies

Back by popular demand, the 2019 industry heatmap provides a high level overview of the latest developments in the European novel therapy manufacturing space across The United Kingdom, Belgium, Greece and Switzerland, among others. 

With the 2018 commercialisation of prominent Autologous therapies such as KITEs Yskarta and Novartis’ Kymriah in the global market, more and more companies are beginning to move towards commercially based products. Yet despite these unquestionable industry growths, challenging issues can hinder – and even halt – groundbreaking progress in its tracks. There are still no established routes to market and with continuous changes in regulatory requirements across different global markets achieving any form of standardisation is difficult.

Download this free resource to gain valuable insights on some of the biggest challenges:

• globalising production and commercialisation
• scalability
• cost efficiency
• regulatory pathways
• supply and logistics

With many therapies advancing to later clinical trial phases and moving even closer to commercialisation, Pharma IQ have created an industry report overview of the key European cell and gene therapies, pinpointing  the stage of research or development.  Some of the biggest challenges to commercialise include quality assurance, quality by design, scalability and cost efficiency, but there is no doubt that the competitive nature of this industry only further enhances these challenges. Using an interactive list, the industry report summaries these key topics and aims to evaluate strategies developed by leading experts to provide you with the best tips on how to overcome the hurdles of commercalisaion. 

Additional key benefits of downloading the report:

• Evaluation of the global trend for expansion
• Predictions from the FDA commissioner of where cell and gene therapy products will be by 2025
• Summary of the commercalisation progress of advanced therapy trials 

Download the Cell and Gene Therapy Industry Report now.

Back by popular demand, the 2019 industry heatmap provides a high level overview of the latest developments in the European novel therapy manufacturing space across The United Kingdom, Belgium, Greece and Switzerland, among others. 

With the 2018 commercialisation of prominent Autologous therapies such as KITEs Yskarta and Novartis’ Kymriah in the global market, more and more companies are beginning to move towards commercially based products. Yet despite these unquestionable industry growths, challenging issues can hinder – and even halt – groundbreaking progress in its tracks. There are still no established routes to market and with continuous changes in regulatory requirements across different global markets achieving any form of standardisation is difficult.

Download this free resource to gain valuable insights on some of the biggest challenges:

• globalising production and commercialisation
• scalability
• cost efficiency
• regulatory pathways
• supply and logistics

Joining this year’s curated programme will take you through a series of sessions from translation and collaboration to ensuring GMP compliance and optimising scalability. This year’s forum is also your one-stop shop for:

• Building manufacturing capabilities that are compliant, efficient and commercial
• Engaging in our GMP compliance training day to ensure that your process development optimisation does not come at the cost of process compliance
• Hearing from 18+ industry experts to benchmark your manufacturing practices and taking home industry leading solutions
• Optimising your manufacturing processes from end-to-end with topics covering every stage of the manufacturing process
• Helping to plan for your transition towards manufacturing at scale to ensure that your next therapy is market ready
• Gaining a practical understanding of data integrity issues and how it relates to manufacturing
• Exploring how to best identify, reduce and prevent potential data integrity breaches

To find out more information on the sessions, download the full agenda of the conference here. To request a copy to be sent via email, please click here.

Optimise every facet of your manufacturing strategy by participating at the Cell and Gene Therapy Manufacturing Forum.

Benefits of attending: 

• Join a curated programme taking you from translation and collaboration to ensuring GMP compliance and optimising scalability - this year’s forum is your one-stop shop for building manufacturing capabilities that are compliant, efficient and commercial
• Engage in our GMP compliance training day to ensure that your process development optimisation does not come at the cost of process compliance
• Hear from 18+ industry experts to benchmark your manufacturing practices and take home industry leading solutions
• Optimise your manufacturing process from end-to-end with topics covering every stage of the manufacturing process
• Plan for your transition towards manufacturing at scale to ensure that your next therapy is market ready

Download this free presentation on how to design a robust and cost-effective ‘off-the-shelf’ supply chain for your cell therapy. With insights from Bone Therapeutics’ PhD Production Associate Director, Anne-Sophie LeBrun, this presentation is designed to ensure that your manufacturing process is as efficient and cost effective as possible

The Bone Therapeutics presentation will give you insights on: 

• Examining cell therapy as a game changer for orthopaedic indications 
• Identifying major indications and on-going clinical trials 
• Evaluating the feasibility of large-scale manufacturing 
• Understanding the journey from a scientific concept to a commercial concept 
• Setting the objectives and taking capacity and costs into consideration 
• Assessing the feasibility of cell expansion and storage
• Plus more.

Fill in your details to download this free presentation. 

The cell and gene therapy manufacturing sphere continues to mature rapidly, with a growing number of companies moving towards commercialising products. This report includes a European Heatmap which provides a high level overview of the latest developments in the European cell and gene therapy manufacturing space, in addition to an detailed industry update which provides information about therapy development throughout Europe.

As cell and gene therapy production continues to move towards commercialisation, it faces new challenges relating to the scalability of manufacturing processes. Both autologous and allogeneic therapies hold their own unique obstacles relating to production and treatment; and the promise of personalised medicines is not without hindrances related to both cost and availability.

We interviewed Andrew Finnerty, General Manager, CCMI Ireland at NUI Galway to discuss this topic in more detail and build a better understanding of how the rapid expansion of this market has brought about new challenges relating to manufacturing scalability , and what will this mean for the future of personalised cell and gene therapies. 

Fast on its way to becoming a multibillion-dollar market, the global cell and gene therapy industry is booming. However, challenges mean that almost three decades after the first gene therapy trial, only three gene therapies have been approved in the EU and one in the United States. This article will look into the challenges around development and manufacturing that need to be addressed so that ambitious pharma and biotechs can continue to develop these innovative medicines. 

The cell and gene therapy manufacturing sphere continues to mature rapidly, with a growing number of companies moving towards commercialising products. This infographic provides a high level overview of the latest developments in the European cell and gene therapy manufacturing space, looking at which therapies are moving into commercialisation in order to treat a wide range of conditions and diseases.

In response to the region’s strengthening presence with the therapeutic method, Pharma IQ presents this Cell and Gene Manufacturing hotspot map.