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Pharmacovigilance of Biosimilars
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
Shehla Hashim, Souleh Semalulu, Felix Omara, Duc Vu
The increase in the development of biological products or biopharmaceuticals presents unique opportunities for monitoring and pharmacovigilance. Biopharmaceuticals are proteins that are generally used to treat a variety of severe and life-threatening diseases. They are fundamentally different from the usual generic products, owing to the size and complexity of the active agents and the manufacturing process. In some jurisdictions, some of these products are authorized for rare diseases as orphan drugs; therefore, information on their safety profile at the time of authorization may sometimes be very limited due to small clinical trial sample size. Although biological products are considered targeted therapeutic drugs, they are associated with several adverse events. The most common safety concerns with biological products include the potential risk of infectious disease transmission, lot-to-lot variability, issues around immunogenicity, hypersensitivity reactions, alterations of immune function; which may lead to increased risks of infection, autoimmunity and/or cancer development, long biological half-lives leading to prolonged pharmacodynamic effects even after cessation of treatment, and unknown short- and long-term risks.
Quality Control
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Biological responses and biological molecules or cellular systems are complex. Application of a biopharmaceutical to a biological system-cultured cells, animal or human, is an attempt to disrupt or bring back a biological system to equilibrium. Indeed, biopharmaceutical treatment may further disrupt or complicate a biological system already out of control. As compared to small drug molecules, many biopharmaceuticals are complex biological entities. Given this information, consider how difficult it is to measure a product’s potency in a complex system. Hence, multiple potency assays provide a greater chance of ensuring product efficacy than does a single potency test, because several potency tests evaluate the impact of the product at multiple points in complex biological pathways. Although the use of a complete living organism (e.g., a whole animal) for FP potency testing brings into play all biological influences on the product and allows measurement of product potency, it is often difficult to develop and validate an appropriate animal model that mimics the human situation. Often, however, it is worth considering animal models for potency testing over in vitro models.
Preformulation of New Biological Entities
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Riccardo Torosantucci, Vasco Filipe, Jonathan Kingsbury, Atul Saluja, Yatin Gokarn
Biopharmaceuticals are pharmaceutical drugs derived from biological sources. Most commonly, these are recombinant proteins or peptides expressed and purified from cells or bacteria and are a relatively recent addition to the pharmacopeia compared to the rich history of small-molecule therapeutics, mainly produced via organic synthesis. Yet biologics account for 25% of total worldwide prescription and over-the-counter sales [1]. In fact, seven of the ten top-selling pharmaceuticals were biologics as of 2016 [2]. This success is due to many factors including exquisite target specificity, superior safety profiles, and favorable pharmacokinetic properties compared with their small-molecule counterparts.
Aqueous biphasic systems based on ethyl lactate: Molecular interactions and modelling
Published in Chemical Engineering Communications, 2023
Stephen D. Worrall, Jiawei Wang, Vesna Najdanovic-Visak
In the last decade, biopharmaceuticals such as therapeutic proteins, drugs and antibodies have been increasingly used to improve the treatment of many diseases thanks to remarkable advances in their production technologies (upstream processes). Although the global biopharmaceutical market was valued at approximately USD 325 billion in 2020 and is expected to rise to USD 497 billion in 2026 (Biopharmaceuticals market 2021), their production costs remain much higher than those of traditional pharmaceuticals because of the high costs of purification methods (downstream processes). Due to their very low concentrations in aqueous solutions, biopharmaceuticals are predominately purified by packed-bed chromatography, but their utilization at a large scale is limited due to the high cost of resins, buffers and other consumables. In addition, the method suffers from long cycle times, hysteresis, resin compression and edge effects, which results in unpredictable flow distribution, low separation efficiency and pressure drops (Rosa et al. 2010). Several alternatives have been suggested in the literature, including flocculation, precipitation, membrane filtration and solvent extraction. As a form of solvent extraction, aqueous biphasic systems have attracted particular attention due to their easy scalability, capacity for continuous operation, and high extraction yields (Iqbal et al. 2016).
Contracts for biopharmaceutical manufacturing based on production cost and capabilities
Published in International Journal of Production Research, 2023
Yasemin Limon, Tugce Martagan, Ananth Krishnamurthy
The pharmaceutical industry spends more than one-fifth of its revenues on the research and development (R&D) of biopharmaceuticals (Florko 2019). Gene therapies, tissues, vaccines, and recombinant proteins are some examples of biopharmaceuticals that made it possible to treat diseases such as cancer, diabetes, and cardiovascular diseases. Biopharmaceuticals are derived from biological systems and are more complex than conventional drugs. For example, a biopharmaceutical molecule might consist of 25,000 atoms in contrast to an aspirin molecule that has only 21 atoms (McKinsey & Company 2014). The difference in drug complexity is complemented by corresponding differences in the associated R&D processes, manufacturing processes, and supporting supply chain activities. In this fast-growing industry, contract development and manufacturing organisations (CDMO) play a critical role in the R&D and manufacturing of new treatments. As such, 80% of the new drug approvals in the United States were attained through strategic collaborations with CDMOs (Miller 2017). These CDMOs are often biotechnology companies with specialised expertise in niche therapeutic areas. In this paper, we investigate contracting decisions between biotechnology companies that differ in their expertise, capability, and cost structures, and provide insights into how different aspects of contract designs can be leveraged to optimise gains from the collaboration.
Resource allocation strategies for protein purification operations
Published in IISE Transactions, 2020
Yasemin Limon, Ananth Krishnamurthy
The biopharmaceutical industry uses biomanufacturing technologies to produce vaccines, blood components and proteins. These products have a wide range of application areas from therapeutic use to diagnosis, drug discovery and drug development. Market analysis conducted by BioPlan Associates (2017) shows that the biopharmaceutical industry has been experiencing an overall consistent growth of 14–15%, and that the global biopharmaceutical market is expected to reach $341 billion by 2023 (Mordor Intelligence, 2018). Unlike traditional pharmaceuticals, biopharmaceutical products are produced using living cells, which brings additional manufacturing and optimization challenges. Although investment in specialized equipment can address these challenges in part, the effective management of skilled human resources (scientists) plays a key role in the ultimate success. Langer and Rager (2017) emphasize that more than 50% of biopharmaceutical companies have at some point run into capacity problems, as a result of poor resource utilization.