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.
Selecting raw materials is one of the earliest steps in the development of mRNA vaccines and therapeutics. The materials you choose have the potential to influence your process development and drug quality.
Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring an existing manufacturing process.
Process characterization is an important step in the product development journey. Download this Q&A article to learn the latest trends, status, and insights into process characterization and validation of monoclonal antibodies and recombinant proteins.
Nucleoside triphosphates (NTPs) are vital components of emerging RNA therapeutics and vaccines. Controlling impurities that may be present in them while understanding key product quality attributes that make them suitable for good manufacturing practice...
Deliver safe and stable products to your patients with the help of Catalent Biologics' Limoges, France site, a European Center of Excellence for early-phase clinical biologics formulation development and drug product fill/finish. It offers an integrated...
Join us as our in-house experts, along with Cecile Bellamy from Pfizer, discuss current and future trends in biopharmaceutical raw material selection.
Catalent offers one of the most extensive selections of biologics analytical services in the industry. We have over 30 years of experience developing and applying analytical methods in support of a wide variety of biologics programs, including mAbs,...
This mRNA eBook was created by Thermo Fisher Scientific, in collaboration with Genetic Engineering & Biotechnology News (GEN), to provide you with prospects of the mRNA technology, tips on scaling up mRNA production, and analytical solutions for mRNA...
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 Phase I & II clinical trials.
Medical science is continuously searching for better ways to administer drugs into the body and to maximize the therapeutic effectiveness of the drugs given.
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.
Catalent Biologics’ Anagni, Italy facility is a world-class, late-stage, and commercial product launch site offering sterile and biologics manufacturing and secondary packaging. With extensive expertise in vial and syringe filling for aseptic liquid and...
With over 30 years of experience producing sterile drug products, Catalent Biologics is your premier manufacturing and packaging partner in Europe. We provide comprehensive solutions to supply your products from Phase 1 through commercial, and we have...
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...
The ability to amplify, modify and fabricate DNA is fundamental to modern molecular biology. Why do so many researchers take their constituent parts for granted?
Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic drugs, metabolites, and biomarkers in preclinical and clinical research.
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...
As the world grapples with the effects of ongoing health crises, the market is expanding quickly as developers shift their focus to proactive therapeutics.
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.
This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing during cell line characterization and BHLRT that are aligned with current and future manufacturing...
The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the...
We have a long history of developing innovative molecular technologies for cell line characterization and lot release testing for the biopharmaceutical industry.
In this technical note, we investigate the interactions between the following: The spike glycoprotein binding with ACE2, Spike glycoprotein and anti-spike antibodies (mAb/ pAb), The spike glycoprotein binding with mAb/pAb to inhibit the interaction with ACE2
Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with scaling your viral vector.
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...
With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization of their therapies.
Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with scaling your viral vector.
Anion exchange chromatography is an important step for viral clearance of monoclonal antibodies. Natrix® Q chromatography membrane improves cost-efficiency. In this study, its performance in the removal of 4 model viruses is measured.
In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. The guidance documents address product development and clinical trial design in general,...
Development of a high-producing cell line supported by a robust upstream process are critical early steps in the production of monoclonal antibodies (mAbs). Optimization of this upstream workflow is essential to deliver a sufficiently high titer to...
Viral contamination is a risk for all biotechnology products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses.
There are several key considerations to how companies should approach commercial-scale manufacturing that may aid the success of their biologic’s launch into European markets. In some cases, there is a need to identify a partner to support the product’s...
The Facility of the Future represents a transformation in how biologics are developed and manufactured.
While new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance....
Upstream processes can be intensified using high cell density cryopreservation, perfused seed train or production processes with steady-state perfusion, or dynamic perfusion. In this white paper, we explore perfusion processes and how they are becoming a...
Strategies such as process intensification have the potential to create shorter lead times, reduce plant footprint, increase flexibility, and reduce COGs.
This white paper describes process modeling and compares the process economics of a conventional upstream process versus three perfused seed train alternatives in combination with either a conventional fed-batch or high-seed fed-batch bioreactor.
Therapeutic proteins are inherently unstable and sensitive to temperature change, shearing, shaking, solvents, ionic strength, purity, protein concentration, pressure and freeze/thaw-drying cycles. Read our latest research in this case study to learn...
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 and had exhausted all currently available treatment options. The client manufactures a drug not...
Viral diseases like rabies, rotavirus and influenza are causing many deaths worldwide, resulting in a strong demand for more productive manufacturing techniques for vaccines, including those based on scalable bioreactor cell culture systems.
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...
mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability...
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...
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...