Bharat Rao, PhD, Justin Hoss
Artificial intelligence, automation, blockchain and other technologies driving digital transformation will fundamentally reshape how drug makers operate, from portfolio planning, drug development, direct-to-consumer marketing, to finance and other administrative functions.
Mike Felo
The release of the BioPhorum Operations Group (BPOG) Biomanufacturing Technology Roadmap1 in July 2017 presented the biopharmaceutical industry with a challenge: to innovate, collaborate, and deliver groundbreaking solutions that will allow manufacturers to dramatically increase production flexibility, speed, and quality while decreasing overall product cost for monoclonal antibodies (mAbs).
Anvit Vasavada, M.S, Sunny Christian, MS, Amitkumar Lad, PhD, Hemant N. Joshi, PhD, MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in September-October, 2018.
Dr. Rose Blackburne, MD, MBA, Dr. Davide Garrisi, DPhC, EMBA
Despite numerous approved and available drugs, established risk assessment and diagnostic criteria, osteoporosis remains underdiagnosed and undertreated in at-risk populations. Clinical development in osteoporosis represents an excellent opportunity to bring new and more affordable medications to patients.
Jeanne Moldenhauer
Antibiotic-resistant microorganisms are becoming a global concern. There are several antibiotic-resistant strains of microbes of clinical significance. Infections from antibiotic-resistant microbes adds significant costs to the healthcare system.
An Nguyen
Competitive Intelligence is crucial towards helping life sciences companies succeed in the market, giving them additional context for every strategic decision.
Rob Weaver
Struggling at root cause analysis? Does it often feel like you’re going in circles to resolve performance issues, continuously going back to refine or implement new corrective actions? Here’s some helpful advice: when engaged in root cause analysis scenarios, don’t initially focus on possible causes, but instead focus on better understanding the problem.
Erin Patton
The Burkholderia cepacia complex (BCC) species are a group of Gram-negative, rod-shaped bacteria which have been shown in recent years to be of concern for patients, and as such, for manufacturers of drugs and health care products that contribute to patient health.
Standard equipment found in a typical microbiology lab includes active air samplers, incubators, pH meters, refrigerators, autoclaves, microscopes, Quebec colony counters, laboratory information management systems and microbial identification systems.
The biopharmaceutical market has risen exponentially on the back of innovation, and science will continue to move forward in areas where innovation is more biology related. So, just as the market has shifted from small molecules to large molecules, development efforts will now focus more on gene- and cell-based therapies.
Dr. Jessica Müller-Albers, Ashish Guha, Manfred Assmus
Multiple unit pellet systems and other types of multiparticulate oral solid dosage forms represent an attractive option to improve the effectiveness of delivering complex medicines targeted for modified release.
Dr. Adela Kasselkus, Erica Weiskircher-Hildebrandt, Dr. Eva Schornick, Dr. Finn Bauer, Dr. Mengyao Zheng
The increasing interest in complex, specialized medicines with specific targets and functionality presents a multitude of considerations to make and hurdles to clear before successfully launching your final drug product. Achieving formulation stability, bioavailability of active pharmaceutical ingredients (APIs), and the desired release kinetics, even in low dosage formulations, are a great challenge that must be overcome for maximal effectiveness.
Elisabeth Vachette, Frédéric Bazin, Jean-Marc Cappia
Biotechnology industries have adopted single-use systems in their manufacturing processes. The adoption started with applications managing peripheral fluids and is now moving towards the main drug manufacturing process. This transition is leading to more challenging safety and quality requirements especially in very demanding or high stress applications such as transportation of bulk drug substances (BDS). There is an increasing need to define safe, stable and integral systems for shipping biopharmaceutical solutions around the world. A new approach for qualifying this process step has been established based on well-known international standards: ASTM D4169.
Dr. Amy Farrell, PhD, Dr. Sara Carillo, PhD, Dr. Jonathan Bones, PhD
In just three decades, monoclonal antibodies (mAbs) have rapidly transformed the face of modern medicine, growing steadily in use to become the dominant biopharmaceutical product class. More than 70 mAb based products have been approved for use in US and European markets, for the treatment of over 30 targets and diseases, including autoimmune disorders, cardiovascular indications, infectious diseases and cancer.
Emília P.T. Leitão, William Heggie, M. Rita Ventura, Osvaldo S. Ascenso, Christopher D. Maycock
In this work we present a synthetic protocol that enabled the gram-scale preparation of key steroids intermediates designed to undergo a green fluorodecarboxylation. The produced intermediates can be used in the synthesis of important active pharmaceutical ingredients. This methodology was applied to a model drug, fluticasone propionate, a potent corticosteroid used in asthma treatment.