Alternatives to Fetal Bovine Serum for Routine Cell Culture

Qualified persons (QPs) play an essential role in the European clinical trial supply chain.

Thermo Fisher Scientific's group of experts delve into the impact of the latest EU Clinical Trial Regulation on pharmaceutical companies and their research and business associates. They examine critical considerations and potential pitfalls in the context of European Union member countries, as well as European Economic Area (EEA) countries.

Whether changing manufacturing sites for scale up or passing from development to manufacturing, technology transfers are a critical process every drug must go through on its route to market.

Poor solubility remains one of the most significant challenges in drug development, affecting over 70% of molecules and hindering their path to clinical trials.

The path to successful drug development is filled with challenges, from managing complex molecules to ensuring bioavailability and regulatory compliance.

Monoclonal antibodies are immunoglobulins produced in a laboratory setting that bind to specific antigens, such as epitopes expressed on the surfaces of cells.

The Applied Biosystems™ TaqMan™ Gene Expression Assays provide a comprehensive solution for advancing oncology research.

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.

The pharmaceutical and biotechnology industries are at a crossroads. Escalating development costs, new modalities, increasing scientific and logistical demands, regulatory complexity

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.

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.

Scaling up buffer preparation is a complex but essential aspect of biopharmaceutical manufacturing.

In the dynamic world of biopharmaceuticals, the demand for innovative and efficient manufacturing processes is higher than ever.

Accelerate the development and manufacturing of mRNA and protein-based vaccines by leveraging Applied Biosystems QualTrak real-time PCR and digital PCR tools for biopharma. Incorporate these highly-sensitive and accurate technologies into workflows across your pipeline for applications in gene expression, genotyping, contaminant testing, and more.

As development costs climb and project timelines grow tighter, the traditional outsourcing model is showing its limitations. Fragmented coordination between CDMOs, CROs, and clinical supply vendors often leads to delays, inefficiencies, and lost opportunities.

Learn how early characterization of drug substances can lead to more effective formulations and avoid costly delays.

Gain valuable insights into scaling up your manufacturing process for Phase III clinical trials. Learn how to avoid common pitfalls and ensure a seamless transition from small-scale to commercial production.

Discover how to expand your portfolio using cost-effective lifecycle management approaches.

In the rapidly evolving landscape of biopharmaceuticals, effective buffer preparation is crucial.

Quality is the underpinning of success in the pharmaceutical development and manufacturing industry.

Once your vaccine is ready for production, there are critical considerations needed in regard to the handling and process for fill/finish.

As your processes evolve, simplify your buffer preparation to enhance efficiency and scalability.

Bring your biologic therapy to market faster with proven autoinjector, pen, and prefilled syringe capabilities.

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, clinical research, laboratory, and supply chain services under a single provider.

A Contract Development and Manufacturing Organization (CDMO) supports sponsors at every stage of drug development, from early research and development to clinical trials through to commercialization.

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.

Peptones support efficient and scalable vaccine manufacturing by improving cell growth, enhancing viral production, and reducing reliance on serum-based media.

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.

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.

Partnering with a single vendor for comprehensive drug development, manufacturing, research, and clinical supply services can accelerate trial starts and substantially reduce development costs, according to new research by the Tufts Center for the Study of Drug Development.

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.

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

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.

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.

Today's pharmaceutical and biopharmaceutical industries face increasing pressure from tightening regulations, rising R&D costs, and growing competition.

Smarter consumables strategies for biosimilar manufacturing

DCTs can take a variety of forms depending on patients’ needs, study protocol, drug company preferences, or regulatory requirements.

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. Achieving right-first-time outcomes and reducing development risks have become essential priorities across the industry.

AOF peptones help improve cell growth, enhance viral production, and reduce reliance on serum-based media in vaccine manufacturing.

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.

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.

Solubility issues are one of the leading barriers to the success of drug development.

Have you experienced inconsistent real-time PCR (qPCR) product performance and obstacles during post-discovery bioanalysis and quality control (QC) assay development? Applied Biosystems™ TaqPath™ general purpose reagents (GPRs) are specifically designed to address these challenges, offering stringent manufacturing QC, exceptional performance, and comprehensive compliance documentation support.