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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

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
 
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News and Press Releases

SP delivers world’s largest installation of commercial freeze dryers for diagnostics production

WARMINSTER, PA (May 25, 2021) – SP Scientific Products (SP) has announced one of the world’s largest simultaneous installations of commercial lyophilizers for use in the production of diagnostic tests. The order, for SP lyophilizers, was made last year by a leading global healthcare company in response to the need for an increase in SARS-CoV-2 testing.
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White Papers

Mauritius Island – An Emerging Centre for R&D in Biotechnology and the Life Sciences

CIDP (Centre International de Développement Pharmaceutique)

Mauritius, the tropical island situated in the Indian Ocean and known worldwide for its beautiful beaches, is also internationally recognised for its rule of law, and political and social stability. Over the past few years, the economy has been successfully transitioned from a monocrop to a diversified innovation-driven and knowledge-based economy, resting on agribusiness, export-oriented manufacturing, tourism, financial services, property development and real estate, ICT-BPO, the seafood industry, a free port, logistics and a nascent ocean economy. Emerging sectors such as healthcare and life sciences are presenting some niche areas for the taking, and the enabling environment is being put in place to make it happen - especially in the light of sustained growth within pharmaceutical, medical device, and clinical research. Important international players are already in operation locally as the country has established the appropriate legal and regulatory frameworks based on international norms, for the development of a strong biomedical research sector.
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Industry Events

A Magic Triangle: Practical insights into lactose-based DPI formulations

30 June 2021, Online webinar

Three leading companies with complementary areas of expertise have joined forces to conduct a unique multidisciplinary study into lactose-based DPI formulations including magnesium stearate. Their findings will give generic players a head start in the development process so that they can tap into this rapidly growing market. Lactose specialist DFE Pharma, powder processing technology manufacturer Hosokawa Micron and machine-building expert Harro Hoefliger will be presenting the key insights from their research to interested parties during a joint webinar on the 30th of June.
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