Cell and gene therapy validation requirements are still in development. As more experience and knowledge are gained on manufacturing processes, some challenges will be resolved and others will be identified. This article delves into challenges and proposed solutions for manufacturing process validation, designing PPQs for autologous cell therapy, and analytical method validation.
- Genome Sequencing Research For Rare Diseases & The Future Of The Field
- Regulatory Perspectives For CGT Development: Continued Need For Standards And Perseverance
- Are You Leveraging KOLs For Biopharma Market Access As Much As You Could Be?
- Harnessing The Human Virome For The Next Generation Of Gene Therapy Vectors
- RNA Takes The Spotlight In The Era Of Precision Medicine
- Collaborating With The FDA For Rare Disease Clinical Trial Success: Our Experiences
- The Pharmacological Treatment Pipeline For Traumatic Brain Injury
- The 4 Ways AI Implementation Is Changing The Future Of Precision Medicine
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Implementing GMP For Early-Phase Development With Cartesian Therapeutics Co-Founder And CEO, Dr. Murat Kalayoglu
For nascent cell and gene therapies, navigating the earliest phases of clinical development can prove particularly challenging, as even small issues in manufacturing can spell big problems. In this episode of The Business of Biotech, Dr. Murat Kalayoglu, Co-Founder and CEO of Cartesian Therapeutics, talks about the importance of focusing on GMP manufacturing during Phase I clinical trials to maximize a therapy's potential for success.
Determining Residual Bead Count: Application Of Micro-Flow Imaging To CAR T-Cell Manufacturing
Residual bead count is typically determined manually by the naked eye and microscopy. But this approach is highly limited in its ability to accurately discern beads from cells and other potential in-process impurities, resulting in reporting uncertainties that risk regulatory approval. In this application note, you’ll see how automation via image-based Micro-Flow Imaging™ (MFI) technology gets you the quantitative and morphological data you need to have confidence in distinguishing between beads, T cells or other potential contaminants.
A Custom, Multiplex Human Coronavirus Serological Assay
R&D Systems, a Bio-Techne brand, has developed a novel custom Luminex serological assay hat distinguishes between coronavirus subtypes. Using our high-quality recombinant proteins, this antigen-down assay saves time and precious sample by multiplexing many coronavirus subtypes simultaneously in each sample.
Preparing Clinical Trial Documents For Europe’s New CTIS
Are you ready for the new Clinical Trial Information System (CTIS)? With European Clinical Trial Regulation (EU-CTR) 536/2014 set to go into effect in January, all stakeholders will be required to submit study information through CTIS. Be prepared with these best practices.
Efficient Transition Of Human Pluripotent Stem Cell Cultures From StemFlex™ Medium Into NutriStem® hPSC XF Medium On Matrigel®
Establishing ideal culture methods has been a known challenge in human pluripotent stem cell (hPSC) research since the late 90s. This paper reviews the suggested method for adapting hPSCs originally cultured in StemFlex™ to NutriStem® hPSC Medium. Read how for this transition, a simple and direct adaptation can be followed with cultures exhibiting similar morphology as well as higher levels of pluripotency when compared to StemFlex™.
Overcoming Obstacles In AAV Viral Vector Manufacturing
Rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral-vector manufacturing platforms. The upstream and downstream processes of AAV manufacturing can be fairly straight-forward at small scales. However, obstacles often are encountered when a developer progresses toward larger volumes for clinical and commercial manufacturing. In this article we discuss overcoming obstacles that often come up during transfection, clarification, and the separation of empty and full capsids.
Manufacturing And cGMP For Cell And Gene Therapies
Ultimately, two objectives exist for the commercial manufacture of advanced therapy medicinal products (ATMP) and cell and gene therapies (CGT). The first is to deliver an advanced therapeutic benefit to patients, and the second is to capture a return on investment for the manufacturer. Achieving both objectives depends critically on the manufacturing decisions taken throughout the therapy development process. Learn action-oriented solutions for establishing cGMP manufacture of cell and gene therapies to progress your development programs towards commercialization.
Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies
Recently approved cell and gene therapies are delivering impressive results for patients who otherwise have exhausted all treatment options or have had no options available to them. However manufacturers are faced with many challenges in the journey from development to commercialization. Within this challenging environment, a number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress towards commercialization of these remarkable therapeutics.
Protein A Resin Reduction Achieved With Process Transfer From Batch To BioSMB
A biopharmaceutical manufacturer was looking to reduce the operating costs of existing purification steps with high resin costs. In this case study they review transferring an existing batch chromatography process into a multi column format and then scaling up that process to an continuous perfusion run. The result was a dramatic reduction in protein A resin requirements.
Meeting Diverse Biologic Pipeline Development Challenges
The biopharma manufacturing industry has been evolving at an unmatched pace. Understanding and managing diverse molecule challenges is key to reaching patients safely and efficiently.
CELL AND GENE LIVE
In this on-demand webinar Cell & Gene Chief Editor Erin Harris talks with Dr. Mark Gilbert, SVP of R&D at Acepodia, Thomas Lequertier, Head of Cell Therapy Manufacturing Unit at Celyad Oncology, and Luděk Sojka, Ph.D., Chief Technology Officer at SOTIO, about the innovations in manufacturing that can reduce both costs and risks.Cell & Gene Live On-Demand
CELL AND GENE CONTENT COLLECTIONS
The list of conditions that stem cell therapy could help treat may be endless, including conditions such as Alzheimer’s disease, heart disease, diabetes, and more. Researchers are now studying stem cells to see if they could help treat a variety of conditions that impact different body systems and parts. In this e-book from Cell & Gene, we cover topics from stem cells in development to novel technologies in stem cell research and stem cell therapies.More Content Collections