Selecting raw materials is one of the earliest steps in the development of mRNA vaccines and therapeutics. The materials you choose have the potential...
Content provided by Thermo Fisher Scientific - Biosciences | 15-May-2023
| White Paper
Learn more about process development and manufacturing in the mRNA space to enable successful scale-ups of mRNA production for therapeutic applications.
Content provided by Thermo Fisher Scientific - Biosciences | 22-Mar-2023
| White Paper
Nucleoside triphosphates (NTPs) are vital components of emerging RNA therapeutics and vaccines. Controlling impurities that may be present in them while...
Content provided by Recipharm AB | 28-Nov-2022
| Case Study
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...
Content provided by Pfizer CentreOne | 18-Nov-2022
| 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...
Content provided by Wheeler Bio | 17-Nov-2022
| 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...
Content provided by Actylis – The Partner of Choice | 16-Nov-2022
| White Paper
Actylis manufactures buffers, process solutions, cleaning solutions, Water for Injection (WFI) for further processing, and custom liquid blends in compliance...
Content provided by Actylis – The Partner of Choice | 09-Nov-2022
| White Paper
By combining 75+ years of manufacturing and sourcing expertise, Actylis provides a wide portfolio of GMP ingredients to the pharma & biopharma market,...
Content provided by Wheeler Bio | 20-Oct-2022
| White Paper
To solve for the significant bottlenecks often presented by conventional cell line development processes, this article discusses how Wheeler Bio is leveraging...
Content provided by CellCarta | 08-Aug-2022
| Case Study
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...
Content provided by 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...
Content provided by Curia | 16-May-2022
| White Paper
The clinical value of biologics for the treatment of many disease indications has been accompanied by phenomenal sales. By 2026, the global market for...
Content provided by Altasciences | 10-May-2022
| White Paper
Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic...
Content provided by Baxter BioPharma Solutions | 16-Feb-2022
| White Paper
The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...
Content provided by Baxter BioPharma Solutions | 16-Feb-2022
| White Paper
Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...
Content provided by Viral Safety for mAb: Prevent, Detect, Remove | 23-Nov-2020
| White Paper
This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing...
Content provided by Viral Safety for mAb: Prevent, Detect, Remove | 16-Nov-2020
| 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,...
Content provided by Take the Right Path Upstream with MilliporeSigma | 02-Nov-2020
| 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...
Content provided by Viral Safety for mAb: Prevent, Detect, Remove | 12-Oct-2020
| Application Note
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...
Content provided by Take the Right Path Upstream with MilliporeSigma | 01-Oct-2020
| 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...
Content provided by Take the Right Path Upstream with MilliporeSigma | 05-Aug-2020
| White Paper
Upstream processes can be intensified using high cell density cryopreservation, perfused seed train or production processes with steady-state perfusion,...
Content provided by MilliporeSigma - Gene Therapy | 05-Aug-2020
| White Paper
While new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing...
Content provided by Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020
| White Paper
This white paper describes process modeling and compares the process economics of a conventional upstream process versus three perfused seed train alternatives...
Content provided by Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020
| White Paper
Strategies such as process intensification have the potential to create shorter lead times, reduce plant footprint, increase flexibility, and reduce COGs.
Content provided by Take the Right Path Upstream with MilliporeSigma | 12-May-2020
| 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...
Content provided by Viral Safety for mAb: Prevent, Detect, Remove | 12-May-2020
| 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...
Content provided by Take the Right Path Upstream with MilliporeSigma | 12-May-2020
| 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...
Content provided by 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,...
