• Multiplexing: Managing Risk With Proven, Single-Use Solutions

    Typically, demand forecasts for drugs prior to launch reflect a huge range of expectations. This illustrates just how hard it is to forecast accurately. Instead of trying to make better predictions (which will never be wholly accurate nor truly able to remove risk), or erring on the side of overcapacity (which is a drag on ROC), developers and CDMOs should seek manufacturing flexibility.

  • Delivering Clinical Trial Medications Direct-To-Patient

    In a perfect world patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately that is not always the case. In recent years the Direct-to- Patient model, which brings medical procedures to a patient’s home, has emerged as a solution for Sponsors to increase patient recruitment and retention in clinical trials.

  • Droplet Digital PCR Applications Guide

    Droplet Digital polymerase chain reaction (ddPCR™) was developed to provide high-precision, absolute quantification of nucleic acid target sequences with wide-ranging applications for both research and clinical diagnostic applications. ddPCR measures absolute quantities by counting nucleic acid molecules encapsulated in discrete, volumetrically defined water-in-oil droplet partitions. Droplet Digital PCR using Bio-Rad’s QX100™ or QX200™ Droplet Digital PCR system overcomes the previous lack of scalable and practical technologies for digital PCR implementation.

  • Viral Quantification - Adeno-Associated Virus Vector Genome Titer Assay

    Recombinant adeno-associated virus (AAV) is rapidly becoming the vector of choice for human gene therapy applications due to the ability to achieve prolonged gene expression in a variety of tissues without a significant immune response or toxicity. Large-scale manufacture of AAV vector for clinical trials requires a high degree of sophistication in both process design and lot release assays. Read how ddPCR represents a highly precise method to determine AAV vector genome titers and is not unduly influenced by inefficient amplification or standard curve issues.

  • Electronic Lab Notebooks - Implementing Next-Generation Laboratory Informatics

    Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.

  • Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products

    The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

  • Particle Engineering For Inhalation Drug Delivery

    Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe. Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs. This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.

  • Engineering Approaches To Respiratory Drug Delivery: Mannitol Case Study

    Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. Read our article to learn more.

  • Counting DNA Molecule By Molecule

    Digital PCR is an established nucleic acid (NA) quantification technology, which enhances the broad use of PCR across molecular biology laboratories globally through improved precision and accuracy. Organizations that impact the quality of nucleic acid measurement and testing, adopted digital PCR early on and have since been pioneering its use for improved accuracy and precision in NA measurement. Ultimately, this will positively impact the quality of NA measurements generally and, more specifically, clinical NA testing. Molecular counting of nucleic acid molecules is the next measurement paradigm.

  • Cell Therapy Scale-Up Strategies For Commercial Success

    To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.

FEATURED PRODUCTS AND SERVICES

The ZE5 Cell Analyzer is an innovative new flow cytometer with flexible configurations to meet a broad range of experimental complexities and throughput needs. Whether it’s a low-complexity, or a high-complexity experiment, the ZE5 Analyzer has up to 30 parameters and provides a truly expandable flow cytometer. This flexibility makes the ZE5 Analyzer accessible for novice flow cytometry users yet flexible enough for the most experienced flow cytometry professionals

The complexity of high cost biologics means comparator may be one of the highest line items in your clinical trial budget. Our Comparator Center of Excellence Team can consult and assist you in managing the full breadth of your comparator sourcing needs. Utilizing Fisher Clinical Services’ comparator sourcing services will provide you access to a global sourcing network and an overall de-risked supply chain. Currently 15 out of the top 20 worldwide pharmaceutical and biotechnology companies, as well many small pharmaceutical and biotech start-ups, actively utilize our comparator sourcing and strategy services.

Scaling down size, scaling up capabilities

Cost and speed are critical components in biomanufacturing. A compact chromatography system easily adjusted to fit projects needs can help you stay on top of this—whether you are developing a process or manufacturing at pilot scale.

Biacore 3000 works with high sensitivity and short analysis times for binding studies...
HyperSpec VS15 Imaging Spectrograph is a compact, high throughput spectrograph providing unrivaled spectral-spatial imaging.

Gibco BioProduction Services can support and partner with you no matter what your comfort level is with intellectual property.  Our team of professionals will work with you to provide the best customized solution for your particular situation.  You will receive exceptional customer service from start to finish.

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