News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical methods.
Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders should actively partake in their evolution and prepare for the ensuing changes.
Review the impact of—not only adding peptones as a supplement to your cell culture—but also the importance of concentration and timing as a feed strategy for unlocking optimal titer yields.
Powered by digital microfluidics, Alto™ revolutionizes real-time interaction analyses by eliminating the need to compromise on quality or time.
Assessing key parameters of the upstream process to achieve high titer while maintaining desired integrity Customizing the downstream process to address the different needs from supercoil plasmid and linear isoform A platform approach with integrated...
According to a recent report, the APAC region saw the highest growth in online sales of probiotic supplements worldwide in 2022.
Learn more about process development and manufacturing in the mRNA space to enable successful scale-ups of mRNA production for therapeutic applications.
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 risk-based thinking to manufacturing innovation.
Actylis manufactures buffers, process solutions, cleaning solutions, Water for Injection (WFI) for further processing, and custom liquid blends in compliance with Good Manufacturing Practices in our new state-of-the-art GMP liquid processing facility in...
By combining 75+ years of manufacturing and sourcing expertise, Actylis provides a wide portfolio of GMP ingredients to the pharma & biopharma market, including excipients, APIs, PIs, amino acids, nucleotides, process solutions and buffers.
The number of clinical trials featuring RNA-based drug products has increased dramatically since 2020.
To solve for the significant bottlenecks often presented by conventional cell line development processes, this article discusses how Wheeler Bio is leveraging transposon-based gene delivery to compress timelines, increase clone stability, and offer...
The future of the biopharmaceutical industry hinges on its adoption of 21st-century digital tools and automation.
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 your adoptive cell therapy (ACT) meets safety regulations relating to VCN and RCL/RCR levels, even...
At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed to address specific therapeutic development requirements and provide the most highly customized...
Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the available options and provides some considerations for developing & manufacturing the product.
The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting from annual strain selection. The timeline for development of a seasonal influenza vaccine...
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 market to be approximately $100 billion with expectations of it growing to more than $130 billion by...
The preparation of media for use in biopharmaceutical processes can be complex and may carry risks that must be identified, assessed, and mitigated to assure consistency of performance and minimize the likelihood of contamination. There are risks...
We successfully performed microaerobic fermenta¬tion of a probiotic strain, Lactobacillus acidophilus, at a very low oxygen level, representing the natural physiological condition of human gut microbiome, using BioFlo® 120 and 320 control stations.
Our newest strong anion exchange resin provides both high binding capacity and high recovery, even at high flow rates. A rigid bead complete with optimized pores and surface extenders, this robust resin was designed for your large...
3D cell aggregates are of great interest for applications like disease modeling and manufacturing of stem cell-based products. Read more about the cultivation of the human tumor cell line H157 as 3D cell aggregates in a stirred-tank bioreactor.
Aflibercept (Zaltrap®) is a recombinant fusion protein with complex post-translational modifications. Therefore deep understanding of biosimilar development is required to develop a biosimilar like Aflibercept. UGA Biopharma has successfully completed...
Download the eBook written by Catalent experts to learn about innovative products and techniques for scale-up of complex biologics, get optimal cell culture medium and feed to maximize performance potential, novel analytical techniques for monoclonal...
In September 2017, BioPharma-Reporter.com conducted its second annual ‘state of the industry’ survey on its user base of biopharmaceutical industry professionals. The key objective of the survey was to gauge views about the current state of the global...
The Mastercycler X50 is Eppendorf's new PCR cycler with lots of new benefits. Not only can you heat with 10°C/s, you can also optimize two different temperatures in one run, e.g. the denaturation...
With the rising interest in biopharmaceuticals, drug developers need to quickly understand and evaluate the binding of therapeutic antibodies to Fc receptors. Learn more, in this interview with...
The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary...
With the increasing complexity of biologics and growing competition with players ranging from small start-ups to large pharma, an aggressive development timeline is required to bring your biologic...
In May 2016, BioPharma-Reporter conducted its inaugural ‘state of the industry’ survey. The key objective of the poll was to gauge views about the current state of the biopharmaceutical...
The detection of mycoplasma contamination is of utmost concern in bio-therapeutic and vaccine manufacturing. The two pharmacopeia techniques rely on the agar/broth culture test to detect...
The advanced aseptic processing of ADVASEPT® technology can reduce the risk associated with aseptic filling of biologics and drastically reduce the potential of foreign particulates. The...
The aggregation of biopharmaceuticals is a complex process, for efficient analysis it’s essential to carefully select orthogonal methods to minimize gaps in the data. This article discusses...
Download this white paper to learn about two SGS developed assays used to show comparability in reactivity between the reference product and the biosimilar and to assess comparative mitogenesis...
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not able to fully define the physical and biological characteristics of...