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Cell and gene therapies are set to become the new standard of healthcare, but nevertheless remain variable, complex, and difficult to manufacture with consistency.
As an industry, we are building collective knowledge and experience that will help to accelerate development, approval, and delivery of therapies, but we still have some bottlenecks to solve while attempting to bring cost of goods down.
What’s the best way to minimize variability in your process?
Can you seamlessly transition from RUO to GMP?
How can you scale-up manufacturing from bench-top to clinic to large-scale?
To overcome these challenges and set yourself up for regulatory approval, you need high-quality raw materials, cutting-edge manufacturing solutions, and precision analytics that empower you to accelerate development and standardize processes.
Bio-Techne's technologies and services can be tailored to meet your needs, enabling seamless and efficient development and production of cell and gene therapies. Our collective knowledge and expertise positions us well as your collaborator and long term partner. Whether you are developing an immune cell, regenerative, or gene therapy, we are ready to shape the future of healthcare.
Together, we can unlock tomorrow’s therapies.
Immune Cell Therapy
Demonstrating comparability and reproducibility is essential for the advancement of your immune cell therapy. Understanding your therapy’s mechanism of action and quantifying CQAs are complex and can be the source of costly clinical and regulatory setbacks.
Our high-quality, GMP-grade raw materials coupled with precision analytics technology enable you to provide robust, reliable data to determine proof of concept, ensure regulatory approval and accelerate time to patient.
These scalable, flexible solutions can help you adapt to an ever-changing regulatory landscape. We’re also here to help to embed flexibility into your process, so that you can easily adapt your process to meet changing requirements.
These scalable, flexible solutions enable you to seamless move from the lab to the clinic and adapt to an ever-changing regulatory landscape:
- Animal-free RUO and GMP proteins
- Non-viral gene delivery systems
- Immune cell culture solutions
- Automated analytical instruments
Regenerative Medicine
Minimizing variability is the keystone to success when developing regenerative therapies. With consistent, scalable solutions coupled with a reliable supply of high-quality raw materials, we can help you to forge a pathway towards safe, life-changing therapies.
We recognize the challenges you face to scale-up production - that’s why all our regenerative medicine solutions are made with scalability at their core.
We provide tailored solutions to help you throughout the regenerative medicine development workflow, including:
- Animal-free RUO and GMP proteins
- Non-viral gene delivery systems
- Stem cell and organoid culture solutions
- RUO and GMP small molecules
- Spatial biology platforms
- Automated analytical instruments
Gene Therapy
Achieving safe and effective transgene delivery is among the greatest challenges faced by gene therapy developers. The inherent complexity of viral vectors makes them difficult to characterize with consistency throughout development and manufacturing stages.
That’s why we provide precision analytical tools for critical quality attribute analysis to ensure safe, high quality, consistent, and efficacious therapies.
These customizable, flexible, and fast assay and analytics systems provide the high-specificity, automation, and reliable results you need throughout the gene therapy development workflow:
- Spatial biology platforms for in vivo monitoring
- Automated vector analysis and characterization solutions
- Immunoassays
Scale Up & Out With Confidence
Scaling up production from the benchtop to clinical manufacturing is a major hurdle to overcome for all cell and gene therapies. Producing complex cell-based therapeutics at scale is a huge challenge involving long processes and large quantities, but we aim to make this process easier for you.
To make scaling-up easier for immune cell therapy projects, we’ve partnered with Fresenius Kabi and Wilson Wolf to bring you ScaleReady™ — a collaboration that aims to bring immune cell therapies into the clinic faster with simplified, standardized, and streamlined solutions – already used in approved CAR-T drug therapies on the market.
Scalability is at the heart of all our cell and gene therapy solutions, and can be boosted further with our comprehensive portfolio of GMP materials. Get up to full-scale manufacturing and minimize risks with raw materials that provide industry-leading quality, consistency and reliability.
A Smoother Transition from RUO to GMP
Navigating the shift from R&D to clinical manufacturing presents unique challenges, particularly when confronted with the change from RUO to GMP raw materials. To facilitate a seamless transition, we offer a host of GMP materials for cell and gene therapy, including cytokines and growth factors, which are all manufactured in our new specialized animal-free GMP manufacturing facility.
Each GMP product stands as a direct counterpart to our RUO animal-free version, produced in accordance with ISO 9001 certifications, along with adhering to USP and European guidelines. The meticulous approach we take with our RUO and GMP materials ensures that you have a smooth transition process, empowering you with the assurance of a consistent supply and unwavering quality in your raw materials.
Custom Cell and Gene Therapy Solutions
Does your cell and gene therapy manufacturing process have specific volume requirements? To ensure that your process runs as efficiently as possible, and to minimize waste, we can bottle and package bulk reagents to fit your precise process requirements for all of our RUO and GMP grade materials. Our custom solutions include:
- Custom GMP protein and antibody development
- Cell culture media manufacturing services
- Small molecules and chemistry services
- Custom immunoassay development
- Custom flow cytometry reagents
Improve Product Insights with Robust QC and Analytics Tools
Getting your cell and gene therapy products through regulatory approval and onto the market requires accurate, reproducible testing of critical quality attributes.
Our analytical products and services are manufactured to the highest quality assurance measures, empowering you to move forward with confidence, and ensure that your cell and gene therapy products meet your precise quality, purity, and performance requirements.
- Simplify and accelerate your workflow with easy-to-use, automated solutions
- Analyze multiple CQAs with a single platform
- Achieve high-sensitivity cell phenotyping throughout your workflow
- Closely monitor product efficacy and toxicity
On-Demand Cell and Gene Therapy Educational Resources
We’re committed to driving forward cell and gene therapy research in every way possible, which is why we have curated a collection of on-demand educational resources to guide you through your cell and gene therapy journey. Immerse yourself in our educational articles, educational content, and application notes in our resources center.
Dive into a wealth of wisdom through our engaging cell and gene therapy webinars which cover challenges in the field, best practices, and shine a spotlight on the latest advancements. Missed a crucial session? No worries – our on-demand library ensures you're always in the loop, learning at your own pace.
