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Optimize your Biologic’s Analytical Program for Greater Risk Reduction

Merck

Analytical methods are used throughout upstream and downstream processes to help ensure the desired molecule is being produced with the desired purity. In addition to having the right molecule, quality must be confirmed in terms of glycosylation, oxidation, aggregates, activity and concentration. The analytical package must also ensure that all impurities from the manufacturing process and environment are consistently removed.

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Optimize your Biologic’s Analytical Program for Greater Risk Reduction

Cold-chain Bioprocessing Readiness: Mitigating Risk and Protecting Pharmaceutical Products

Entegris

The pharmaceutical industry is migrating rapidly toward a world where drugs, vaccines, and specialized therapies are available on demand to patients anywhere around the globe. Whether accelerating clinical trials to bring new drugs to market or devel oping biosimilars to give more patients access to established commercial drugs, small and midsize production facilities stand to benefit from growing demand. To do so, however, they must be prepared to handle a broader mix of products and increase throughput without sacrificing safety or reliability, while at the same time keeping life-saving medica tions affordable. Such challenges become more difficult when working with products that must be stored and shipped in a frozen state.

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Cold-chain Bioprocessing Readiness: Mitigating Risk and Protecting Pharmaceutical Products

Antibody Internalization: Advanced Flow Cytometry and Live-Cell Analysis Give Rich Insights During Antibody Profiling

Sartorius Group

The natural characteristics of antibodies, such as high binding affinity, specificity to a wide variety of targets, and good stability, make them ideal therapeutic candidates for many diseases. Monoclonal antibodies (mAbs), in particular, deliver promising therapeutic results in several different disease areas, such as autoimmunity, oncology, and chronic inflammation. Researchers’ abilities to improve the breadth of antibodies have been aided by innovative technologies for antibody discovery, for instance, through humanization of mouse antibodies and phage display. However, advanced antibody design techniques create the need for new screening methods so that lead candidates can be quickly and effectively identified as early in the development process as possible.

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Antibody Internalization: Advanced Flow Cytometry and Live-Cell Analysis Give Rich Insights During Antibody Profiling

Pandemic respiratory vaccine clinical trials: a departure from business as usual

ICON plc

Around the world, the “V” words are on everyone’s lips: Virus and Vaccines. In response to the urgent need for a vaccine for COVID-19, researchers are, at time of publication, running 500+ clinical trials (and counting) on a number of antivirals, antibodies and vaccines. Promising possibilities range from novel new drugs/vaccines, repurposing treatments currently indicated for HIV, Ebola and malaria, to monoclonal antibodies and immune serum.

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Pandemic respiratory vaccine clinical trials: a departure from business as usual

Role of Comparators in Clinical Trial Supply

Clinical Services International

CSI analyses the role of comparators in different trial designs and offers expert advice on robust methodology for choosing the most appropriate comparators. Case studies provide real insight on how to choose comparators for rare diseases and oncology studies.

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Role of Comparators in Clinical Trial Supply

Financial implications of off-site visits in clinical research, perception versus reality

Illingworth Research

The concept of patient centricity is still relatively new within clinical trials. For too long, the most important person in the trial has been overlooked… the patient. Here, we explore the benefits of conducting a more patient-centric trial for the patient, site and sponsor through mobile, or ‘off-site’ visits. These advantages are much greater than purely financial, although the financial implications of running a more patient-focused clinical trial may previously have deterred some from this approach. Home nursing in clinical trials continues to be thought of as a high value “premium” service, which many sponsors decline in an attempt to remain within budget for the trial. However, is the actual cost of off-site nursing more expensive than the traditional site model?

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Financial implications of off-site visits in clinical research, perception versus reality

Accelerating the Time from DNA to Material

Merck

Cell line development is a critical step in upstream process development for monoclonal antibodies (mAbs). Unfortunately, the search for the bestproducing clone can be labor- and resource-intensive and is often compared with looking for a needle in a haystack. Cells must first be engineered to produce the biologic of interest and the cell line generated from a high producing clone must deliver a sufficiently high titer to support clinical studies, and ultimately commercialization of the therapeutic.

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Accelerating the Time from DNA to Material

Quality Systems Guide

Research Quality Association

This guide concentrates on the core, underlying principles of quality that are pivotal – explicitly or implicitly – to all quality management standards that impact on research and development.

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Quality Systems Guide

Comparator Sourcing in Oncology Trials

Clinical Services International

This is an exciting time for oncology trials, year on year record numbers of therapeutics are launched and the indications for many drugs on the market are increasing rapidly. Immunotherapies and next generation biotherapeutics are being approved for more tumour types and a growing percentage of the late stage oncology pipeline are targeted biologics.

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Comparator Sourcing in Oncology Trials

Outsourcing and Insourcing: How Eurofins solves the bio/pharma industry’s challenges associated with meeting drug development timelines and budgets with restricted headcounts

Eurofins BioPharma Product Testing

Pharmaceutical and biopharmaceutical companies face a significant challenge to get their drug products developed and launched quickly, all while keeping development costs down. One of the most common ways for companies to lower development costs is to manage fixed headcounts. But when the same scope of work still needs to be completed by a designated time with fewer staff members, this presents a significant challenge. So, how do bio/pharma companies solve this ever so common challenge of increasing output while decreasing headcount? There are essentially three options: temporary staffing, outsourcing, or insourcing.

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Outsourcing and Insourcing: How Eurofins solves the bio/pharma industry’s challenges associated with meeting drug development timelines and budgets with restricted headcounts
 
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PM Group Worldwide Ltd and The Datateam Media Group announce acquisition of Samedan Ltd

PMGroup Worldwide Ltd and The Datateam Media Group are pleased and excited to announce the acquisition of pharmaceutical publishers Samedan Ltd. The deal brings together three publishing powerhouses in the pharmaceutical and healthcare sector - with Samedan joining PMGroup and PharmaTimes Media Ltd as part of The Datateam Media Group’s healthcare division.
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White Papers

Nanoparticle Tracking Analysis. A Review of Applications and Usage in the Analysis of Exosomes and Microvesicles

NanoSight

The study of exosomes and other cell-derived microvesicles is an area of rapidly growing importance and the subject of intense interest and research. The previous lack of suitable methods for their detection, analysis, enumeration and phenotyping is proving to be a significant limitation in these studies. This mini-review shows the degree to which the technique of Nanoparticle Tracking Analysis (NTA) is helping to address these problems.
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