Alternatives to Fetal Bovine Serum for Routine Cell Culture
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White Papers
Suitable Alternatives to Fetal Bovine Serum
Whitepaper: Qual Tark biopharma ecosystem
Learn how the curated QualTrak offering of qPCR and dPCR instruments, reagents, and assays can help streamline biologics development.
A new study reveals substantial efficiency gains
The pharmaceutical and biotechnology industries are at a crossroads. Escalating development costs, new modalities, increasing scientific and logistical demands, regulatory complexity, and mounting pressure to accelerate timelines are creating unprecedented challenges for drug developers.
Advancements in Biopharma: Enhancing Drug Development with Thermo Fisher Scientific’s qPCR Solutions
The biopharma industry is rapidly advancing, with the cell and gene therapy (CGT) market valued at $18 billion, including 27 approved gene therapies, 65 approved cell therapies, and 26 RNA therapies as of 2023.
Applications for qPCR in therapeutic monoclonal antibody development and manufacturing
Monoclonal antibodies are immunoglobulins produced in a laboratory setting that bind to specific antigens, such as epitopes expressed on the surfaces of cells. They can be used to treat various diseases, including some forms of cancer.
Quantifying the ROI of Integrated CDMO-CRO Models in Drug Development
As development costs climb and project timelines grow tighter, the traditional outsourcing model is showing its limitations.
How to optimize your results and overcome specificity challenges in gene expression analysis
Real-time PCR for gene expression analysis is commonly used to quantify gene-specific RNA transcripts expressed by cells or viruses. However, gene expression analysis presents unique challenges, as experimental results often do not follow predictable patterns, and reliable positive controls are not always available.
Enhancing the efficiency of CAR T cell therapy manufacturing through automated bioprocessing
This white paper describes the significance of Cellmation Software in automating and integrating the CAR-T cell manufacturing workflow. Modular instruments enhance flexibility and scalability in cell therapy manufacturing. However, automated control of the processes is critical in reducing manual touchpoints and ensures efficiency and safety.
Protect Your Pharma Supply Chain from Global Disruptions
In today’s unpredictable world, pharmaceutical supply chains face growing risks—from geopolitical tensions and regulatory shifts to raw material shortages and natural disasters.
Revolutionize Biomanufacturing with Advanced Process Liquid Outsourcing
In the dynamic world of biopharmaceuticals, the demand for innovative and efficient manufacturing processes is higher than ever. Contract Development and Manufacturing Organizations (CDMOs) are increasingly turning to outsourcing Process Liquid Buffers (PLBs) to enhance scalability, quality, and flexibility.
Buffers in Biomanufacturing
The complexity and criticality of buffer preparation have grown of late for several reasons. Advances in product offerings, bioprocessing materials, process technologies and facility design have increased the number of factors to be considered
Plan for success with your process liquid and buffer preparation
Preparation for manufacturing is a complex and challenging undertaking. Process liquids and buffers are important components within the bioprocessing workflow, and preparation of these solutions can be very resource intensive.
Buffers and process liquids for biopharmaceutical production: considerations for scale-up and outsourcing
The global biopharmaceutical market is rapidly growing, with small and midsize organizations outpacing large organizations in market share growth.
Optimize Your Buffer Preparation for Scalable Biomanufacturing
Scaling up buffer preparation is a complex but essential aspect of biopharmaceutical manufacturing. As biopharma evolves with innovative therapies such as mRNA vaccines and CGT therapies, the need for efficient and cost-effective buffer production has never been greater.
TaqMan Assays to support your oncology research breakthroughs
The Applied Biosystems™ TaqMan™ Gene Expression Assays provide a comprehensive solution for advancing oncology research. With over 2.8 million predesigned assays available across more than 30 species, they cover a wide range of cancer types, including liver, melanoma, colorectal, glioblastoma, breast, prostate, ovarian, lung, lymphoma, and pancreatic cancers, among others.
Optimize Your Buffer Preparation for Biomanufacturing
In the rapidly evolving landscape of biopharmaceuticals, effective buffer preparation is crucial. From mRNA vaccines to cell and gene therapies, the need for robust and economical buffer solutions has never been greater.
Transforming CDMO partnerships through a holistic understanding of quality
Quality is the underpinning of success in the pharmaceutical development and manufacturing industry.
Technology transfers: Best practices for optimizing success and mitigating risk
Whether changing manufacturing sites for scale up or passing from development to manufacturing
Infographics
Redefining value in drug development and clinical research
The Tufts Center for the Study of Drug Development, a nonprofit research group affiliated with Tufts University School of Medicine, analyzed the financial and operational impact of aligning manufacturing
Simplify Your Buffer Preparation with Thermo Fisher Scientific
As your processes evolve, simplify your buffer preparation to enhance efficiency and scalability. Whether you're considering outsourcing or handling in-house, we offer solutions to optimize your production and minimize risks.
Streamline Your Buffer Preparation with Thermo Fisher Scientific
Efficient buffer preparation is essential for scaling up biopharmaceutical manufacturing. Whether you choose to outsource or manage buffers in-house, the right approach can save time, reduce costs, and minimize risks
9 ways to ensure a reliable technology transfer
Technology transfer is a vital process in the pharma industry, crucial for scaling up drug production, relocating to a new facility, or transitioning to a new outsourcing partner.
Four special fill/finish considerations for vaccine production
Once your vaccine is ready for production, there are critical considerations
On Demand Webinars
QuantStudio 7 Pro Real-Time PCR System
Learn about an automatable qPCR instrument with functionality to support regulatory requirements and generate reliable data.
Navigating the transition from research to clinical-scale cell therapy manufacture
The journey from concept to commercialization for cell therapy candidates is fraught with complex challenges, including escalating costs in process development
Next-gen cell therapy manufacturing: leveraging flexibility and automation for success
With the surge in cell therapy approvals and advancements, the pressure to scale production while maintaining quality and safety standards has never been higher.
Patient-centric sterile injectables: Improving patient experience through formulation and delivery
A common theme in healthcare today, patient centricity in pharmaceutical manufacturing
Articles
Optimize Vaccine Development with Peptones
Peptones support efficient and scalable vaccine manufacturing by improving cell growth, enhancing viral production, and reducing reliance on serum-based media.
Optimizing Multiplex qPCR: TaqMan QSY and QSY2 Probes vs. IDT Probes
The new Applied Biosystems™ TaqMan™ QSY™2 probes enhance multiplexing capabilities, allowing users to detect up to six targets in a single real-time PCR (qPCR) reaction with increased sensitivity, dynamic range, and performance consistency
Revolutionize Drug Development with AI/ML
Poor solubility remains one of the most significant challenges in drug development, affecting over 70% of molecules and hindering their path to clinical trials.
Accelerate Drug Development with In Silico Modeling
The path to successful drug development is filled with challenges, from managing complex molecules to ensuring bioavailability and regulatory compliance.
Early-stage biotech: The wrong outsourcing strategy costs more than time
For early-stage biotech companies, innovation is just the beginning—the greater challenge lies in navigating the complex development path with limited time, resources, and visibility.
Ensuring compliance through collaboration: managing raw material changes in cell and gene therapy regulatory filings
Cell and gene therapy manufacturing depends on specialized raw materials, ranging from upstream reagents to downstream excipients, that are essential to product quality, consistency, and safety.
Outsourcing supply chain and buffer preparation activities
As the biopharmaceutical market evolves and continues a steep upward trajectory of growth, biopharmaceutical drug innovators increasingly rely on contract development and manufacturing organizations (CDMOs) to help them achieve their mission.
Case Studies
Accelerator™ Drug Development: Driving Global Clinical Research Success Through Integrated Governance
Coordinating large-scale clinical research programs across multiple geographies, vendors, and timelines often creates complexity and risk.
Accelerator™ Drug Development: Collaborative Timeline Management Drives Speed and Simplicity in Global Vaccine Trial
Coordinating a global Phase III vaccine study across 6,000+ subjects, 170 sites, and 20+ countries presents extraordinary logistical and regulatory challenges from cold-chain distribution to regional labeling and site activation.
Accelerator™ Drug Development: Streamlining Preclinical Pathways for a Fast Transition to First-in-Human Trials
For emerging biotech companies, the path from preclinical development to first-in-human (FIH) trials can define the future of a therapy. Challenges such as regulatory hurdles, incomplete API characterization,and inefficient study design often lead to costly delays and lost momentum.
Streamline Bioprocessing with Ready-to-Use Buffer Solutions
Rapid growth can bring rapid challenges. When a leading Contract Development and Manufacturing Organization (CDMO) faced an unexpected surge in demand for one of their client’s newly approved therapeutics, they encountered significant bottlenecks in buffer preparation
eBooks
Spend wisely, scale effectively
Smarter consumables strategies for biosimilar manufacturing
Flow cytometry in microbiology
Culture-based techniques have been considered a core tenet of microbiology for many decades. However, their limitations have rendered them suitable for only a small percentage of culturable microbes.
Accelerate Drug Development with Innovative 360° CDMO and CRO Solutions
As R&D costs continue to rise and timelines extend, biotech and pharmaceutical companies are under increasing pressure to deliver therapies faster and more efficiently
Advancing CAR-T therapies : the importance of closed processes in manufacturing and future innovations
Find out how T cell therapy is transforming the personalized treatment of autoimmune and rare diseases with two innovative forms of T cell therapy which are at the forefront of research
App Notes
Advance Vaccine Development with AOF Peptones
AOF peptones help improve cell growth, enhance viral production, and reduce reliance on serum-based media in vaccine manufacturing.
App Note: QuantStudio 7 pro qPCR systems
See how QuantStudio systems and consumables generate consistent results across instruments and operators to help ensure data concordance.
Residual plasmid quantification in gene therapy manufacturing workflows using the QuantStudio Absolute Q Digital PCR System
Residual DNA testing is an established method that is routinely used for the assessment of product quality and safety in the development of gene therapies, vaccines, and similar biotherapeutics.
Efficient gene expression profiling for biomarker identification using multiplex quantitative PCR
Quantitative PCR (qPCR) has long been recognized as a powerful tool for analyzing nucleic acid levels. When combined with reverse transcription of RNA to cDNA before qPCR (RT-qPCR), researchers can sensitively and specifically determine the relative quantities of mRNA transcripts in samples.
Harnessing the versatility and flexibility of CTS Dynabeads magnetic beads in CAR T cell manufacturing
his application note showcases the key challenges of isolating T cells from varied patient source material and why manufacturers require flexible yet reliable magnetic bead-based solutions that help ensure the production of a safe and efficacious CAR T cell product.