MilliporeSigma is skilled in the art of GMP viral vector production and technology innovation, having manufactured viral vectors for over 20 years and producing more than 500 lots of drug substance from preclinical through commercial production. Our comprehensive portfolio of best-in-class bioprocessing products and technologies combined with our application expertise can help you quickly scale up to reach your process goals. Our BioReliance® testing services employ the broadest range of vector types to speed progress of gene therapy development. Full characterization, potency, analytics, safety, and stability testing combine to ensure safe therapies for patients awaiting treatment.
China’s Emerging Biotech and CDMO Environment
China is going through a phase of robust growth of biotech companies. This is being boosted by market demand, returning scientists-turned innovators and a favorable capital market. This is especially the case in the Science and Technology Innovation Board in China (STAR) and the Hong Kong Stock Market.
4 Considerations For Overcoming Challenges In Gene Therapy Testing
With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.
Investment In Internal Process Development And Manufacturing Enables Rapid Product Development
Speed to the clinic and patient safety are important goals when working to bring novel genetic therapies to patients. Read how Homology Medicines decided to invest in internal development and manufacturing operations not long after the Company’s founding. This allowed for efficient collaboration, integration, and iteration as Homology developed a commercial platform process that supports both gene therapy and gene editing constructs.
Ensuring Viral Vector Supply For Gene Therapies
The rapid success of gene therapies also brings with it a number of challenges, the most significant being ensuring a sufficient viral vector supply, despite shortened development timelines. This infographic demonstrates how cells grown in suspension are much better suited for large-scale production of viral vectors, what to consider in order to successfully scale-up your viral vector production, including the challenges faced in upstream upscaling, and a specific solution we’ve developed to help you address these challenges.
Mind The Gaps: A Perspective From The World Of Academic Spinouts
Depending upon your perspective, “emerging” biotech could mean any number of things, ranging all the way from the recent spinout of an academic lab to a publicly held company developing a therapeutic that has not yet reached the marketplace. Read more about what current situations may cause anxiety for a company in the emerging biotech space.
Covid-19 Impact On Bioprocessing: PART 3 Long-Term Changes
Although suppliers have proven themselves rather robust in their dealing with the pandemic and business is continuing generally uninterrupted, there will be significant long-term changes.
Covid-19 Impact On Bioprocessing: PART 2 Fears To Be Addressed Due To Covid-19
We interviewed major biopharmaceutical industry senior bioprocessing decision-makers, and bioprocessing suppliers in the US and Europe. The impact on emerging biopharma companies as well as smaller suppliers may actually be a small silver-lining for some, during this global, horrific event.
COVID-19 Impact On Bioprocessing: PART 1 Accelerating Trends
Because of the urgent demand for treatments, vaccines and assays, the pharmaceutical and biotech industries are experiencing disruptive, often chaotic, increased demands on resources.
Process Development For Viral Vector Manufacturing
Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with scaling your viral vector. This infographic outlines the history of gene therapy and presents critical factors that need to be taken into consideration for a successful path to commercialization. It also explains how to enhance speed to market and improve quality with a templated process.
The Importance Of Scalability In Viral Vectors
Gene therapy has the potential to change countless patients’ lives. Diseases that lacked cures or even treatments may be addressed with these new classes of therapeutics. This potential has spurred new investments in the drug development and commercialization space.
Robust Harvest Clarification For Adeno-Associated Viral Vectors
This article demonstrates that depth filters clarify AAV vectors, helping to overcome the unique separation challenges presented by these important vectors for gene therapy.
Understanding The Road To Commercialization
With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization of their therapies. Choosing a contract development manufacturing organization (CDMO) to ensure a smooth road to commercialization is essential. Contact us directly to learn more about picking the right strategic partner.
Hiring Challenges In Bioprocessing For Start-Ups
Hiring bioprocessing pros has been a stubborn problem for more than a decade, challenging start-up companies as the supply of qualified staff gets tighter. Here's how the industry could solve the problem.
The Race From Lab To Clinic: 5 Critical Steps To Success
While the fastest path is often tempting, the right path is to ensure product quality and viability while expediting the development timeline. These five steps are key to putting your molecule on the right path.
Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus
In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. This paper summarizes several key changes that will impact developers of gene therapies.
How MilliporeSigma Handles Quality Inspection Readiness
While quality management is a major priority across the life sciences industries, it takes specific precedence in viral gene therapy. Heather Burnell, Head of Quality at MilliporeSigma’s viral vector manufacturing facility in Carlsbad, CA, highlights how quality management is embedded in the MilliporeSigma culture.
Process Development Is Key To Patient Success
Process development (PD) is a critical component to the commercialization of viral vector-based therapies. While some gene therapy developers may want to speed through this operation to meet deadlines, doing so can put product quality, safety, and efficiencies at risk.
The Future Of MilliporeSigma’s Gene Therapy CDMO Through The Lens Of History
On the road to becoming a global industry leader in cell and gene therapy, our viral vector manufacturing organization has undergone a major transformation over the last two decades. Marc Gaal, Director of Program Management at MilliporeSigma, details the history of the business as well as some of the milestones achieved since its inception.
Gene Therapies: Overcoming The Biggest Hurdles In Manufacturing
The last decade saw a great rise in gene therapy popularity. Today, gene therapies have reached a momentum with hundreds in clinical development and several therapies approved in recent years. However, the rapid growth of the sector and the complexity of gene therapies has resulted in a number of challenges in process development, scale-up, manufacturing, and regulatory guidelines. Download the infographic to find out how to overcome these challenges and what’s ahead for gene therapy.
Downstream Process Intensification Of Virus Purification Using Single-Use Membrane Chromatography
The production of viruses, whether for use as viral vaccines, viral vectors for gene therapy, or oncolytic applications, requires complex processes that can translate into high costs, as well as slow development timelines and time to market. This article presents several case studies highlighting the advantages of process intensification using Natrix® single-use membrane chromatography to increase your productivity and reduce your capital and operational manufacturing costs.
Utility Of Next-Generation Sequencing (NGS) For Biosafety Assessment Of Biological Products
By delivering significantly more data than traditional Sanger-based sequencing methods, NGS opens a range of possibilities for the analysis of diverse DNA and RNA populations.
Making Novel Therapies A Reality Part 1
Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.