Biopharmaceuticals Technology | Encyclopedia MDPI

Summary

The advent of biopharmaceuticals in current medicine brought enormous benefits to the treatment of life-threatening human diseases (e.g., cancer, diabetes and neurodegenerative disorders), and improved the well-being of many people worldwide. The global portfolio of these therapeutic products include proteins and antibodies, nucleic acids, and cell-based products, and continues to expand at a rapid pace - approvals in the period 2015-2018 essentially double the typical five-yearly historical approval pace (G. Walsh, Nat. Biotechnol., 36:1136-1145, 2018) -, representing a significant share of the entire market of pharmaceuticals.

Innovation in the (bio)pharmaceutical industry has been driven towards the development of cost-effective manufacturing processes, envisaging the delivery of products in high quantity, with superior quality (purity), and high specificity, with the ultimate goal of benefiting patients. Progress in this direction have resulted from the application of novel technologies in the upstream stage (high-throughput, single-use devices, statistical optimization of media and fermentation conditions, QbD, and continuous processing), while at the downstream level, chromatography has evolved through the development of new resins and ligands, coupled with advances in process modelling, operating and control strategies.

An emerging trend is the application of alternative solvents such as ionic liquids and deep eutectic solvents, in which their structure and physicochemical properties can be tuned to address unmet needs in (bio)pharmaceutical research. These compounds may be derived from natural and reneawable sources and hold great promise in the development of efficient, sustainable and cost-effective biopharmaceuticals purification processes.

This Entry Collection aims to provide the latest progresses achieved in pharmaceuticals bioprocessing. We welcome submissions of original research, comprehensive reviews and perspectives, including, but not limited, to the following fields:

- Upstream processing (genetic engineering, systems biology, difficult-to-express proteins, expression conditions, Quality by Design approaches, process analytical technologies);

- Chromatographic purification methods (process modelling and control, continuous bioprocessing, design and characterization of resins and ligands, new formats);

- Alternative purification methods (aqueous biphasic systems, filtration, crystallization, precipitation);

- Application of neoteric solvents in upstream and downstream stages;

- Analytical characterization of biopharmaceuticals (stability, post-translational modifications, biological activity, immunogenicity);

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Entries

Topic Review

Synthetic Polymers

Unlike natural polymers, the chemical composition, functional group type and extent of functionalization, molecular weight, charge density and distribution, degradation and stability of synthetic polymers can be engineered to maximize antiviral activity against a specific virus type.

886
05 May 2022

Topic Review

Nanotechnology-Assisted Cell Tracking

The beneficial effects of nanotechnology in the field of disease diagnosis and therapy depends on the evolution of innovative approaches for cell tracking in living subjects. Recent developments in the use of nanotechnologies have contributed to advance of the high-resolution in vivo imaging methods as well as targeted disease approaches. In this context, the application of strategies for the biomimetic design and functionalization of nanoparticles (NP) to be used for directing cell labelling and their intracellular retention have received growing interest and require further investigation to improve direct cell tracking protocols allowing non-invasive long-term targeted monitoring through in vivo imaging.

534
05 May 2022

Topic Review

Biomarker-Driven Drug Development

Biomarker-driven drug development in age of personalized medicines. A biomarker life cycle is broken down into 3 stages - discovery, translation, and qualification. Researchers review current development strategies and technologies applied at each of these stages, with emphasis on the use of real-world data as an important source of supporting evidence.

760
28 Apr 2022

Topic Review

Paracetamol

Paracetamol (acetaminophen) is one of the most commonly prescribed drugs worldwide. Synthetized over 150 years ago, paracetamol is highly efficient as analgesic and antipyretic and is on the list of the World Health Organization’s essential medicines. Paracetamol is also a hypothermic agent.

701
28 Apr 2022

Topic Review

G Protein Coupled Receptor 158

G-protein-coupled receptors (GPCRs) remain one of the most successful targets for therapeutic drugs approved by the US Food and Drug Administration (FDA). Many novel orphan GPCRs have been identified by human genome sequencing and considered as putative targets for refractory diseases. Of note, a series of studies have been carried out involving GPCR 158 (or GPR158) since its identification in 2005, predominantly focusing on the characterization of its roles in the progression of cancer and mental illness. However, advances towards an in-depth understanding of the biological mechanism(s) involved for clinical application of GPR158 are lacking.

627
28 Apr 2022

Topic Review

The Development Perspective and Recommendations of Biosimilars

461
27 Apr 2022

Topic Review

Clinical Efficacy and Safety, Interchangeability of Biosimilars

Clinical safety and efficacy studies add substantial cost and time to the approval of biosimilars. However, this argument will have little weight if these studies were able to add additional value over and above the rest of the testing. Interchangeability is a legally defined path in the US biosimilar guidance.

365
27 Apr 2022

Topic Review

Pharmacology of Biosimilars

Testing in animals is an old routine used for new drugs to avoid serious toxicity to humans. However, biological drugs may not always show a pharmacologic response in animal species; thus, the toxicity is an extension of the pharmacological response for biological drugs. Clinical pharmacology comparisons comprise the most relevant testing to support the biosimilarity of a biosimilar candidate. When a novel drug is developed, PK/PD testing is carried out on many volunteers to understand the diversity of disposition in terms of gender, age, and genetic distribution.

569
27 Apr 2022

Topic Review

Analytical Assessment of Biosimilars

The analytical assessment includes testing physicochemical and functional attributes to establish a claim of biosimilarity. How closely a biosimilar candidate should match the reference product will remain questionable since a reference product is approved based on whatever quality attributes it presents; a biosimilar candidate, on the other hand, must match these quality attributes, even if the reference product’s attributes are not the most desirable.

1.5K
27 Apr 2022

Topic Review

Regulatory Pathway of Biosimilar

While most biosimilars have rigidly followed the WAC pricing of 3–30% below the reference product in the US, we can anticipate significant price drops in the future. Since the US market represents 40% of the world market, price drops in the US are pivotal in presenting the overall benefits of biosimilars. In the EU, the pricing of biosimilars is a regional issue, presenting a range of 30 to 70% of market share and price drops of up to 85%, with Norway, Denmark, and Italy leading the reductions. The success of biosimilars in Europe was due to them achieving widespread acceptance by payers, providers, and patients as an integral part of medicine through an extensive program involving preparing stakeholders, investing in evidence generation (e.g., the NorSwitch trial), and introducing incentive models to share payer savings with hospitals. A key component of this success was forced switching, which is not possible on legal grounds in some countries and due to commercial interest in others.

1.1K
27 Apr 2022

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