• Effectively Managing Data In Process Development

    Addressing data management challenges during drug development calls for a deeper understanding of the shortcomings of today’s methods and the factors you need to consider when adopting a solution to overcome them.

  • Process Considerations For Closed Connected Processing

    Closed connected processing poses new challenges with respect to process development, planning, and execution. This white paper reviews the benefits and challenges with closed processing and connected processing. By giving examples for the implementation of closed, connected processing in large-scale manufacturing, you will be able to explore and assess options that work for your objectives.

  • Lessons Learned Executing A Closed Connected Processing From Start To Finish

    Biomanufacturing is under increased pressure to adapt to market demands, such as reducing costs and bringing life-saving therapies to the people who need it faster. We performed an evaluation of biomanufacturing technologies, which can potentially improve efficiencies, and offer our findings as additional data for consideration when adopting these methods. Read our recommendations from our execution of a closed and connected mAb process from design considerations to scale-up, including the small-scale modeling that directed our process at manufacturing scale.

  • Getting Your Investigational Drug Regulatory Ready

    Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

  • Upstream Platform For Continuous Lentiviral Vector Production

    Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

  • Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors

    Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.

  • Enabling Fast, Appropriate Drug Product Supply For Phase 1 Clinical Trials

    Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.

  • Product Development For An Oral Solid Dosage Using Continuous Manufacturing

    A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.

  • NMR And Mass Spectrometry In Pharmaceutical Development

    In this article, the ability of nuclear magnetic resonance (NMR) and mass spectometry (MS) to characterize product composition is demonstrated using detailed examples.

  • Analyzing Product Formulation Using Raman Spectroscopy

    There are several advantages to using Raman spectroscopy for product quality control along with optimizing the percentage of carbamazepine in an amorphous material produced by hot melt extrusion. Compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world all containing the same API itraconazole.

FEATURED PRODUCTS AND SERVICES

The BioCycle Sequencing Kit, using biotinylated terminators and ThermoSequenase, incorporates terminator labeling

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.

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.

The cryogenic probes belong to a family of high-resolution probes with application in NMR technology...

Fully scalable single-use bioreactor family.

 UPCOMING TRAINING COURSES