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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

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?
 
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News and Press Releases

Bormioli Pharma runs Envision 2020: A Digital Event to Showcase The New Strategic Directions, Brand-New Product Portfolios and Prototypes

Parma, 24 November 2020 – Bormioli Pharma will showcase its brand-new product portfolios, products and prototypes during “Bormioli Pharma Envision 2020”, a digital event that will take place in the first half of December open to all the stakeholders. The event will be the occasion to get in touch with the leading European pharma packaging manufacturer in glass and plastic in such hectic times for the industry. Even during the Covid-19 pandemic, the company has kept the momentum for its expansion and growth process, finalizing new investments and M&As to enlarge its industrial platform and the products range.
More info >>


White Papers

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.
More info >>


Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
More info >>

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