Review
Biotechnology & Applied Microbiology
Gene Schaefer, John Balchunas, Timothy Charlebois, John Erickson, Roger Hart, Sandeep B. Kedia, Kelvin H. Lee
Summary: The challenge of introducing new technologies into established industries is not unique to biopharmaceuticals, but it is crucial for the long-term competitiveness and delivery of therapies, particularly for new treatment modalities such as cell and gene therapies. This review identifies barriers to technology adoption and proposes enablers and suggestions for synergy and connection between innovation in product discovery and manufacturing, and across supplier, discovery, manufacturing, and regulatory arms.
BIOTECHNOLOGY AND BIOENGINEERING
(2023)
Review
Pharmacology & Pharmacy
Fernando A. Garcia, Eva Gefroh
Summary: In this study, process models were developed to analyze the impact of biomanufacturing costs on commercial scale operations, highlighting the importance of facility design and operation in achieving a balance between meeting product demand and minimizing production costs. By evaluating different facility design strategies, such as traditional large stainless-steel facilities and small portable-on-demand (POD) facilities, the study compared bioprocessing platforms and demonstrated how continuous bioprocessing has become a popular and cost-effective method for manufacturing high-quality biopharmaceuticals. The analysis also revealed the significant influence of market demand fluctuations on manufacturing costs and plant utilization, with implications for overall patient costs.
DRUG DISCOVERY TODAY
(2023)
Article
Engineering, Chemical
Christina Yassouridis, Astrid Durauer, Theresa Scharl, Friedrich Leisch, Cecile Brocard, Anne-Luise Tscheliessnig
Summary: Efficient development of multistep downstream processing of biopharmaceuticals depends on fast and robust transfer from bench to manufacturing-scale, with equivalence tests used to assess product quality and quantity changes. Simulation study results suggest that a minimum sample size of four in the reference group, evaluation of outliers in reference data, and low variance with the proposed EAC by Limentani are necessary for reliable test decisions. Following these recommendations, reliable product yield comparability was achieved in chromatographic purification of a biopharmaceutical.
CHEMICAL ENGINEERING SCIENCE
(2021)
Article
Chemistry, Multidisciplinary
Bozhidar-Adrian Stefanov, Maysam Mansouri, Ghislaine Charpin-El Hamri, Martin Fussenegger
Summary: This article describes a method of trigger-inducible release of proteins from engineered cells for biopharmaceutical production in locations lacking infrastructure. The method has been successfully applied to various proteins and demonstrates adaptability and flexibility.
Article
Pharmacology & Pharmacy
Roberto Menzel, Andre Korzun, Christopher Golz, Tanja Maier, Ina Pahl, Armin Hauk
Summary: Polysiloxanes are widely used in biopharmaceutical manufacturing equipment, but the release of dimethylsilanediol (DMSD) can cause problems. E&L testing and effective removal methods are necessary to ensure the quality of drug products.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Review
Chemistry, Applied
Alana C. Szkodny, Kelvin H. Lee
Summary: This review highlights the key milestones in the production of biopharmaceuticals and emphasizes the maturity of the technologies used and the importance of understanding the interaction between product quality and processing conditions.
ANNUAL REVIEW OF CHEMICAL AND BIOMOLECULAR ENGINEERING
(2022)
Article
Biotechnology & Applied Microbiology
John Erickson, Jeffrey Baker, Shawn Barrett, Ciaran Brady, Mark Brower, Ruben Carbonell, Tim Charlebois, Jon Coffman, Lisa Connell-Crowley, Michael Coolbaugh, Eric Fallon, Eric Garr, Christopher Gillespie, Roger Hart, Allison Haug, Gregg Nyberg, Michael Phillips, David Pollard, Maen Qadan, Irina Ramos, Kelley Rogers, Gene Schaefer, Jason Walther, Kelvin Lee
Summary: The ambitious 10-year collaborative program aims to invent, design, demonstrate, and support integrated biopharmaceutical manufacturing technology to transform the industry, with goals including improved control, robustness, and security of supply, reduced capital and operating costs, flexibility in product supply, and faster development and supply chain velocity.
BIOTECHNOLOGY AND BIOENGINEERING
(2021)
Editorial Material
Biotechnology & Applied Microbiology
Gary Walsh, Eithne Walsh
Summary: Monoclonal antibodies continue to lead in numbers and sales within the biopharmaceutical industry, although individual COVID-19 vaccines have become the highest-grossing products.
NATURE BIOTECHNOLOGY
(2022)
Article
Engineering, Chemical
Kevin Gibson, Jorge C. Oliveira, Denis Ring
Summary: This study aims to evaluate the impact of buffer management strategy and technology selection on overall process efficiency using process mass intensity as a metric for comparison. The results show that buffer management has a critical impact on overall process mass intensity, and single-use systems are greatly superior to stainless-steel systems in terms of overall process efficiency.
Review
Medicine, Research & Experimental
Ohnmar Khanal, Abraham M. Lenhoff
Summary: The development and implementation of continuous biomanufacturing can reduce production costs, accelerate production speed, and improve drug quality to meet growing market demand. However, challenges remain in the integration, monitoring, and control of traditionally segmented unit operations.
Article
Biotechnology & Applied Microbiology
Yeong Wook Song, Yong-Beom Park, Jinseok Kim
Summary: LBEC0101, an etanercept biosimilar, has been approved in Japan and South Korea for all etanercept indications, including RA. Studies have shown that LBEC0101 has pharmacological characteristics, pharmacokinetics, efficacy, and safety comparable to the etanercept reference product.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2021)
Review
Biochemical Research Methods
Abdulrahman Tuameh, Stephen E. Harding, Nicholas J. Darton
Summary: The high demand for monoclonal antibody (mAb) therapeutics has led to efforts to improve their costly manufacturing process, specifically the purification stage. Host cell proteins (HCPs) are a major challenge at this stage as they are produced and often co-purified with the desired mAb product, leading to potential degradation. This review discusses various techniques that can be used upstream and downstream of mAb production to enhance HCP clearance, including new approaches that may replace current methods for improved HCP reduction and overall mAb product quality and stability.
BIOTECHNOLOGY JOURNAL
(2023)
Article
Engineering, Chemical
Vaibhav Kumar, Munawar A. Shaik, Arpit Jain
Summary: Several common limitations and inconsistencies in scheduling models for multiproduct biopharmaceutical facilities were identified in the literature, leading to overestimation of reported objective values. An improved unit-specific-event-based model was proposed in this study to address these issues, resulting in better outcomes compared to existing literature models.
CANADIAN JOURNAL OF CHEMICAL ENGINEERING
(2022)
Article
Biotechnology & Applied Microbiology
Sandeep B. Kedia, Jeffrey C. Baker, Ruben G. Carbonell, Kelvin H. Lee, Christopher J. Roberts, John Erickson, John E. Schiel, Kelley Rogers, Gene Schaefer, Stefanie Pluschkell
Summary: The Manufacturing Readiness Levels (MRLs) are well-established tools for describing technology maturity, and the Biomanufacturing Readiness Levels (BRLs) provide a specific viewpoint for the biomanufacturing industry.
BIOTECHNOLOGY AND BIOENGINEERING
(2022)
Article
Medical Informatics
Zhiying Pan, Wenying Huang, Jianhong Pan, Gary Koch
Summary: The development of biosimilars has been increasing in recent years. Bridging studies are a viable strategy to introduce approved biosimilar products from one region to another. A novel statistical methodology for designing and analyzing biosimilar bridging studies has been presented in this paper.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
(2021)
Review
Oncology
A. Krendyukov, M. Schiestl, N. Hoebel, M. Aapro
SUPPORTIVE CARE IN CANCER
(2018)
Article
Oncology
William C. Lamanna, Katharina Heller, Daniel Schneider, Raffaele Guerrasio, Veronika Hampl, Cornelius Fritsch, Martin Schiestl
JOURNAL OF ONCOLOGY PHARMACY PRACTICE
(2019)
Review
Oncology
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascon
Correction
Oncology
Matti Aapro, Andriy Krendyukov, Martin Schiestl, Pere Gascon
Article
Pharmacology & Pharmacy
David Goldsmith, Frank Dellanna, Martin Schiestl, Andriy Krendyukov, Christian Combe
CLINICAL DRUG INVESTIGATION
(2018)
Review
Pharmacology & Pharmacy
Hillel P. Cohen, Andrew Blauvelt, Robert M. Rifkin, Silvio Danese, Sameer B. Gokhale, Gillian Woollett
Letter
Pharmacology & Pharmacy
Hillel P. Cohen, Andrew Blauvelt, Robert M. Rifkin, Silvio Danese, Sameer B. Gokhale, Gillian Woollett
Article
Pharmacology & Pharmacy
Johanna Mielke, Franz Innerbichler, Martin Schiestl, Nicolas M. Ballarini, Byron Jones
Review
Oncology
Andriy Krendyukov, Martin Schiestl
CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
(2020)
Review
Oncology
Martin Schiestl, Gopinath Ranganna, Keith Watson, Byoungin Jung, Karsten Roth, Bjoern Capsius, Michael Trieb, Peter Bias, Julie Marechal-Jamil
Article
Oncology
Hillel P. Cohen, Dorothy McCabe
Review
Oncology
Hillel P. Cohen, Sohaib Hachaichi, Wolfram Bodenmueller, Tore K. Kvien, Silvio Danese, Andrew Blauvelt
Summary: This paper reviews the evidence on whether switching between biosimilars of the same reference biologic provides similar safety and efficacy profiles, and finds that there is no reduction in effectiveness or increase in adverse events during the switching process.
Article
Oncology
Hillel P. P. Cohen, Matthew Turner, Dorothy McCabe, Gillian R. R. Woollett
Summary: Biosimilars have been approved in the USA for over a decade and in Europe for almost two decades, playing a crucial role in improving patient access to healthcare. However, accessibility to biological therapies remains a challenge in some markets. To address this, it is important to streamline the development process of biosimilars without compromising their quality, safety, or efficacy.
Article
Public, Environmental & Occupational Health
Sreedhar Sagi, Pradeep Anjaneya, Sameer Kalsekar, Andrea Kottke, Hillel P. Cohen
Summary: This study reviewed post-approval pharmacovigilance data for eight marketed biosimilars from one MAH, demonstrating that these biosimilars can be used as safely as their respective reference biologics for up to 18 years in a real-world setting. The long-term safety of biosimilars shown in this study provides strong support for the concept of biosimilarity and suggests that similar conclusions about safety may be reached for other biosimilars developed and approved to high standards by major health authorities like EMA and FDA.
Letter
Health Policy & Services
Hillel P. Cohen
JOURNAL OF PHARMACEUTICAL POLICY AND PRACTICE
(2018)