Thermo Fisher Scientific - Biosciences | 22-Mar-2023
| Technical / White Paper
Nucleoside triphosphates (NTPs) are vital components of emerging RNA therapeutics and vaccines. Controlling impurities that may be present in them while...
When Arcturus presented its mRNA vaccine candidate to Recipharm, it was at the stage of a frozen product, a ready-to-administer sterile injectable for...
Pfizer CentreOne | 18-Nov-2022
| Technical / White Paper
Medical science is continuously searching for better ways to administer drugs into the body and to maximize the therapeutic effectiveness of the drugs...
Wheeler Bio | 17-Nov-2022
| Technical / White Paper
As the Pharma 4.0 initiative sets a new industry paradigm, more biomanufacturing companies are asking how they can design and build facilities that apply...
Actylis – The Partner of Choice | 16-Nov-2022
| Technical / White Paper
Actylis manufactures buffers, process solutions, cleaning solutions, Water for Injection (WFI) for further processing, and custom liquid blends in compliance...
Actylis – The Partner of Choice | 09-Nov-2022
| Technical / White Paper
By combining 75+ years of manufacturing and sourcing expertise, Actylis provides a wide portfolio of GMP ingredients to the pharma & biopharma market,...
Wheeler Bio | 20-Oct-2022
| Technical / White Paper
To solve for the significant bottlenecks often presented by conventional cell line development processes, this article discusses how Wheeler Bio is leveraging...
Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring...
Thermo Fisher Scientific | 25-Jul-2022
| Case Study
The ability to amplify, modify and fabricate DNA is fundamental to modern molecular biology. Why do so many researchers take their constituent parts for...
The clinical value of biologics for the treatment of many disease indications has been accompanied by phenomenal sales. By 2026, the global market for...
Altasciences | 10-May-2022
| Technical / White Paper
Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic...
Baxter BioPharma Solutions | 16-Feb-2022
| Technical / White Paper
Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...
Baxter BioPharma Solutions | 16-Feb-2022
| Technical / White Paper
The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...
Viral Safety for mAb: Prevent, Detect, Remove | 23-Nov-2020
| Technical / White Paper
This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing...
Viral Safety for mAb: Prevent, Detect, Remove | 16-Nov-2020
| Technical / White Paper
We have a long history of developing innovative molecular technologies for cell line characterization and lot release testing for the biopharmaceutical...
The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials,...
Take the Right Path Upstream with MilliporeSigma | 02-Nov-2020
| Technical / White Paper
In this technical note, we investigate the interactions between the following: The spike glycoprotein binding with ACE2, Spike glycoprotein and anti-spike...
Effective drug discovery and development relies on the availability of predictive preclinical model systems. Technologies based on human induced pluripotent...
Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with...
With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization...
Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with...
Anion exchange chromatography is an important step for viral clearance of monoclonal antibodies. Natrix® Q chromatography membrane improves cost-efficiency....
In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy...
Take the Right Path Upstream with MilliporeSigma | 01-Oct-2020
| Technical / White Paper
Development of a high-producing cell line supported by a robust upstream process are critical early steps in the production of monoclonal antibodies (mAbs)....
Viral contamination is a risk for all biotechnology products. Recent studies have shown that viral retentive filtration is one of the most robust steps...
Take the Right Path Upstream with MilliporeSigma | 05-Aug-2020
| Technical / White Paper
Upstream processes can be intensified using high cell density cryopreservation, perfused seed train or production processes with steady-state perfusion,...
MilliporeSigma - Gene Therapy | 05-Aug-2020
| Technical / White Paper
While new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing...
Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020
| Technical / White Paper
This white paper describes process modeling and compares the process economics of a conventional upstream process versus three perfused seed train alternatives...
Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020
| Technical / White Paper
Strategies such as process intensification have the potential to create shorter lead times, reduce plant footprint, increase flexibility, and reduce COGs.
Take the Right Path Upstream with MilliporeSigma | 12-May-2020
| Technical / White Paper
The first commercial monoclonal antibody (mAb) was approved in 1986 and today, the global market is large and growing. Reports estimate the size of the...
Viral Safety for mAb: Prevent, Detect, Remove | 12-May-2020
| Technical / White Paper
The use of animal models for the detection of adventitious agents has been a feature of biologic testing packages for many decades. However, as alternative...
Take the Right Path Upstream with MilliporeSigma | 12-May-2020
| Technical / White Paper
The preparation of media for use in biopharmaceutical processes can be complex and may carry risks that must be identified, assessed, and mitigated to...
Experimentation at small scale is crucial for the cost-efficient development of bioprocesses, which then can be transferred to larger volumes. We have...
We successfully performed microaerobic fermenta¬tion of a probiotic strain, Lactobacillus acidophilus, at a very low oxygen level, representing the natural...
Rising interest in gene therapy-based applications leads to increasing demands in scalable production systems for viral vectors. Find out how Cevec Pharmaceuticals...
Roquette Pharma Solutions | 14-Jun-2019
| Case Study
Therapeutic proteins are inherently unstable and sensitive to temperature change, shearing, shaking, solvents, ionic strength, purity, protein concentration,...
CHT XT is the newest addition to the CHT family of media. It has been designed for superior physical robustness to ensure it can be used repeatedly over...
3D cell aggregates are of great interest for applications like disease modeling and manufacturing of stem cell-based products. Read more about the cultivation...
A desperate mother in Germany urged her team of doctors to reach out to a Marken client on behalf of her two year old girl. The child was battling leukemia...
Would you like to enhance your downstream process, increase production capacity and reduce costs? This case study application note demonstrates how implementing...