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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

Clinical Trials in Emerging Markets: Goldmines or Landmines?

Pharm-Olam, LLC

Over the past decade, biopharmaceutical companies have increasingly turned to emerging markets as a way to reduce clinical trial costs and timelines. Areas such as Eastern Europe, India, and Latin America—with their ready population of treatment naïve patients—can be an answer to the intense competition for patients seen in developed markets. Many of the countries within these regions may now be considered as “emerged” countries but yet, conducting trials in these regions does require some special attention and expertise. Before deciding to conduct studies in these areas, companies should have a full appreciation for the ethical, medical, regulatory, legal, and operational hurdles that must be surmounted for success. Here we highlight a number of those issues and offer our recommendations for how sponsor companies can deal with them effectively.

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Clinical Trials in Emerging Markets: Goldmines or Landmines?

The Emerging Use of Social Media in Orphan Disease Drug Research

Worldwide Clinical Trials Ltd

The use of various social media platforms, such as Twitter, Instagram, Facebook, and LinkedIn, for dissemination of clinical trial information has created a cornucopia of possibilities enabling clinical trial performance. Characterized by a people-to-people immediacy, social media permits extraordinarily adaptive modification of study information in real-time, and it does so in a highly targeted fashion.

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News and Press Releases

First cellularized collagen membrane implant to regenerate heart tissue in patients with ischemic heart disease

• 3P Biopharmaceuticals and Viscofan go ahead with this innovative project of regenerative medicine for cardiac use • Beginning of Phase I clinical trial in a group of 10 patients
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White Papers

CRSF Label - Child-Resistant Blister Packs With Booklet Label

Faubel & Co. Nachfolger GmbH

This case study explains how Faubel was commissioned by a leading global pharmaceutical company to develop a label for an aluminum blister pack with 14 cavities, which was used as part of a multinational clinical trial. This label was intended to both protect infants from erroneous ingestion and facilitate use by seniors.
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Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>

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