FEATURED ARTICLES

• Applying High Throughput Processes To Optimize AAV Titers

  A growing number of AAV product developers are recognizing the value in moving to suspension as early in development as possible in order to optimize production.

• Viral Safety Handbook

  Since production templates depend on cell culture processes, biopharmaceuticals are susceptible to adventitious agent contamination. Explore a holistic overview of viral safety consolidating decades of expertise and process understanding.

• Millipore® CTDMO Services: The Industry’s Experienced Choice

  Learn how we simplify bringing life-changing molecules to market, from pre-clinical to commercial, with our CTDMO services designed to support global clients.

• Viral Vectors: Are We There Yet?

  What must we do as an industry to continue the momentum of cell and gene therapies and ensure these revolutionary treatments become a reality for patients who need them?

• Solve Life Sciences Development Challenges With A Global Network Of Collaboration Spaces

  MilliporeSigma experts and biomanufacturers discuss the importance of integration, collaboration, and education to address the industry paradigm shift towards novel modalities, continuous bioprocessing, and better risk mitigation.

• A Plasmid DNA Purification Process For Viral Vector, mRNA, Vaccine Therapies

  Guidance for your plasmid DNA downstream process development, exploring cell harvest, lysis, neutralization and clarification; chromatographic purification; TFF; and sterile filtration unit operations.

• Utilizing Multiple Tech Providers In Gene Therapy Manufacturing

  With a diverse landscape of potential partners, it is important to know what qualities to look for in a technology provider and how to traverse the challenges inherent in managing multiple relationships.

• Viral Clearance Considerations For Adeno-Associated Virus (AAV) Viral Vectors

  There is no one-size-fits-all model for AAV gene therapy products when it comes to viral clearance studies. Here we address some of the questions with respect to viral clearance studies for AAV vectors.

• Explore Performances Of The EX-CELL® CD Insect Cell Medium

  Because viral safety is essential in the manufacture of biopharmaceuticals, we developed a proven Sf9-rhabdovirus-negative insect cell line that improves the safety profile of our customers’ bioprocesses.

• The Impact Of Facility Design On The Safety Of Viral Vectors

  It is critical to vet not just the expertise available at a CDMO, but also the effectiveness of their facility design to reduce risk and meet scale-up needs.

• Strategies For Clarifying Harvest Feed Streams In Viral Vector Bioprocessing

  The goal of clarification is to prepare the cell culture feed stream for downstream chromatography and purification. In this poster, we explore data driven strategies for clarifying harvest feed streams.

• Perspectives Of Value-Driven, Integrated Solutions In Gene Therapy

  With an integrated solutions provider, you can leverage a comprehensive suite of advanced technologies and expertise that will facilitate your path to market and benefit you for the lifetime of your product.

• Development Of A Scalable Bioreactor Process For Transient Adeno-Associated Virus Serotype 2 (AAV2) Production

  Review the development of a suspension based AAV upstream production process that provides a more efficient and cost-effective bioprocessing solution for large scale production.

• Unlocking The Potential Of Viral Vectors Through Functional Titer Assays

  This poster reviews two virus-based gene delivery platforms – adeno-associated virus (AAV) and lentivirus (LV) – focusing on the development, validation, and implementation of titration methods used to measure functional titer.

• Optimized Cell Culture Medium For Scalable Viral Vector Production

  MilliporeSigma’s new cell culture medium offers an improved alternative to classical formulations that can help address the constraints in viral vector manufacturing and scale-up.

• Downstream Process For Gene Therapy, Plasmid-DNA Vaccine Development

  A guide to plasmid DNA downstream process development including clarification, TFF, chromatography, and sterile filtration unit operations.

• Beyond 2020: Looking Into The Crystal Ball For Gene Therapy

  Mirror mirror on the wall, what is the promise that Gene Therapy holds for all? The urgency, uniqueness, and uncertainty surrounding gene therapy manufacturing creates many challenges. Let us take a look into the crystal ball of gene therapy to address unanswered questions and plan for what’s next.

• Which Ingredient Are You Missing In Your Gene Therapy Success Recipe?

  In this podcast, Ratish Krishnan, Associate Director for Cell & Gene Therapy talks about the tremendous promise gene therapies have for changing the healthcare paradigm and solutions to some of the biggest challenges in gene therapy manufacturing.

• The Benefits Of Choosing A Suspension System

  With more gene therapy manufacturers needing to increase their batch size and efficiency, it’s necessary to invest in a viral vector manufacturing system that can be scaled up to meet commercial demand. In this infographic, learn how suspension systems offer many benefits that will help viral gene therapy developers enhance their processes and capabilities to better meet patient demands.

• 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.

• How To Automate Continued Process Verification

  This eBook describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.

• 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. 

• How Data Analytics Accelerates Transition To Bioprocessing 4.0

  Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.

• Leveraging The 4 Cs To Deliver Bioprocessing 4.0

  This article explains the 4 Cs of Biopharma 4.0 - the software, automation and analytics tools that allow Control of unit operations, Connection across the process, Collection of data, and Collaboration such as remote support and cloud services.

• Process Development For Viral Vector Manufacturing

  Learn about the history of gene therapy, critical factors for a successful path to commercialization, and how to enhance speed to market and improve quality with a templated process.

• The Importance Of Scalability In Viral Vectors

  With gene therapy, 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.

• 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.

• 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.

• Further Adapting New Bioprocess Technology In An Era Of Change

  Biopharma 4.0 is becoming more tangible every day. Catch up on the initiatives and programs that are defining the application of Industry 4.0 principles for MilliporeSigma technologies and services.

• 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.

• Anticipating The Next Decade Of Gene Therapy

  The next decade will bring improvements including the development of alternative approaches to gene delivery, and advances in upstream and downstream processing, analytical methods and intensified/continuous processing.

• Ensuring Viral Vector Supply For Gene Therapies

  Explore how cells grown in suspension are better suited for large-scale production of viral vectors, what to consider to successfully scale-up production, and a solution to address these challenges.