FEATURED ARTICLES

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• Continued Process Verification: Driving Consistent Quality In Manufacturing

  Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

• Integrated Approach In Managing CPV And APQR

  Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

• Development Strategies For Adenovirus-Based Gene Therapies

  Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

• Regulatory Expertise And CMC Document Preparation To Support mRNA-Based Therapeutic Development

  Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.

• Scaling Up The Learning Curve For Large-Scale AAV Manufacturing

  The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.

• Technology Transfer Considerations

  Speed and flexibility are crucial in the development of a new drug, from the laboratory to clinical trials and ultimately to the market. Explore considerations for a successful technology transfer.

• Process Validation Considerations

  Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.

• Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy

  RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

• The Next Generation Of mRNA Products: Implications For Quality Control

  To fully realize the potential of mRNA as a therapeutic or vaccine modality, developers will need to employ cutting-edge analytical methods to ensure the safety and efficacy of these novel products.

• Accelerating The mAb Formulation Process

  Learn about a one-step process that was developed to streamline formulation, effectively reducing timelines from approximately 14 weeks to 8 weeks for this critical step.

• Accelerate Process Development With Automated Aseptic Sampling

  Discover how implementing automated sampling systems enabled Takeda Pharmaceuticals to achieve new efficiencies in process development.

• De-Risk mRNA Regulatory Approvals

  Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute characterization and lot release testing.

• Strategies For Ensuring Virus Bank Manufacturing Success

  Learn about the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks.

• Benefit From Leveraging Perfusion Early In Process Development

  By addressing the complex needs of cell culture from the start, organizations can take steps to optimize their process, ensuring they are maximizing productivity and product quality.

• AAV Process Intensification Using High Salt Lysis & Salt Tolerant Endonuclease

  Examine how intensifying AAV production with high salt lysis and Benzonase^® Salt Tolerant endonuclease enhances viral yield and infectivity while ensuring DNA removal for patient safety.

• Contrast In Oligonucleotides

  Explore the differences between research-use-only oligonucleotides and those manufactured in compliance with GMP 21 CFR 820.

• Strategies For The Separation And Analysis Of Empty And Filled Capsids

  Explore approaches for the capture and separation of capsids, upstream strategies for reducing the level of empty and partially filled capsids, trends in AAV capsid design impacting purification, and more.

• Streamlining And Enhancing Gene Therapy Production With Automation

  When it comes to determining the appropriate analytics to inform early development, there are a number of variables to consider surrounding cost, operator expertise, and throughput.

• What To Consider For A Modular Facility With Closed Processing

  The emerging trends in the biopharmaceutical industry are driving an even greater need for modular facilities and closed processing. Learn about the progression toward closed processing and more.

• The Post-Pandemic Supply Chain: Improving Resilience Via Value Chains

  The COVID-19 pandemic underscored the vulnerability of global supply chains. Explore lessons learned from the pandemic, the concept of supply chain resilience, what to look for in a supplier, and more.

• Streamlining Biomanufacturing Automation With Connectivity And Integration

  Gain insight into the recent advancements in connectivity and integration technology, the associated challenges, and the importance of a vendor-neutral approach.

• Ensuring Biomanufacturing Resilience For Biologics And Vaccines

  We highlight strategies for ensuring the reliable delivery of health technologies with a focus on vaccines, mAbs, and new modalities manufactured by biotechnology companies and institutes.

• Improving The Characterization Of Gene Therapy Products

  The analysis of over 10 variant callers and other bioinformatics tools for viral variant detection are discussed to better understand how the outcomes can improve gene therapy product characterization.

• Economics For Vaccine Manufacturing: Comparing Traditional To Modern Modalities

  Explore key points from the presentation MilliporeSigma delivered on the analysis and comparison of manufacturing costs between traditional and modern vaccines at the World Vaccine Congress Washington 2023.

• Market Watch And Perspectives On Vaccines Manufacturing In APAC

  Nearly forty biopharmaceutical companies, CDMOs, and research institute executives took part in interviews on the future of vaccine manufacturing. Explore the key findings following these interviews.

• What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product

  Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.

• Novel Gas Delivery, Distribution, And Scalability Strategies

  Our aim was to create scalable, single-use sparger and impeller designs that offer maximum performance capable of supporting high viable cell densities while cognizant of cell shear sensitivities.

• A Power Number Model-Based Approach For Scalable Impeller Designs

  The aim of this work was to use a power number model-based approach for the design of a scalable single-use impeller capable of reaching high power densities with low mixing time and tip speed.

• Cell Line Preparation For Optimal Production

  Discover an experienced, flexible, and capable partner that can help you optimize production from MCB and WCB manufacturing to safe cell bank storage.

• Prevent Costly Bag Leaks In Single-Use Manufacturing

  In the biopharmaceutical industry, bag leaks remain a top pain point for customers. Ultimus® film addresses this costly issue, offering superior protection against leaks, abrasions, tears, and material fatigue.

• 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.

• 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.

• 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 A Variety Of 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.

• 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.

• 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

  Discover a cell culture medium that provides a superior alternative to traditional formulations and can help to overcome challenges in viral vector production 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.

• 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.