Manufacturing Archives - Page 10 of 100 - BioProcess InternationalBioProcess International

Unraveling the Complexities of Technology Transfer

In the biopharmaceutical industry, technology transfer refers to transfer of any process, together with its documentation and professional expertise, between development and manufacture or between manufacturing sites (1). This operation is common in the biopharmaceutical industry for a number of structural reasons. They include the dichotomy between small, innovation-based drug companies and large ones able to conduct late-phase clinical development and endowed with manufacturing capacity; the high capital cost of biopharmaceutical plants, which makes contract manufacturing attractive; and the need…

Developing Advanced-Therapy Products Through Global CDMOs

by Brian Gazaille and Vadim Klyushnichenko

Tremendous growth in the cell and gene therapy (CGT) industry is driving unprecedented demand for manufacturing services. To be sure, advanced-therapy developers increasingly are choosing to install in-house capabilities. Doing so can offer companies greater control of their processes, timelines, and budgets than they might have when outsourcing products (1). But industry experts agree that contract development and manufacturing organizations (CDMOs) will remain integral to CGT manufacturing and commercialization (1, 2), especially with veteran contract partners scrambling to acquire CGT…

Dissolved Oxygen Control Tuning for Cell Culture Applications

by John Longsworth, Nina Schillings and Ma Sha

Proper tuning of dissolved oxygen (DO) controller proportional integral (PI) values is essential for optimal cell culture performance in a bioreactor. When DO-PI values are optimized, gas flows are smoothed, and foaming and cell stress are reduced. Traditionally, this tuning has been performed by using nitrogen gas to purge oxygen from a test solution, thus simulating oxygen demand. That method has several drawbacks, however. First, nitrogen gassing cannot simulate the high demands of high-density fermentation. Second, nitrogen competes with other…

eBook: Cancer Vaccines ⁠— Innovation Fuels an Immunotherapy Renaissance

by Jim Kling

Despite early successes a decade ago, cancer vaccines designed to deliver peptides or proteins — or nucleic acids encoding those antigens — generally have fizzled out since then. As a result, cancer vaccine development and the field of immunotherapy lost some traction overall. But as freelance contributor Jim Kling describes in this eBook, new innovations in product design, testing, and manufacturing are fueling a renaissance in cancer vaccine development. From checkpoint inhibitors to neoantigens, immune regulators, and beyond, companies are…

eBook: Formulation, Fill, Finish ⁠— Biopharmaceutical Drug Products for a Modern Age

by Cheryl Scott, Scott Ewan, Stuart Madden and Ed Maggio

Biopharmaceutical drugs are increasing in sophistication, requiring technological advancements to solve related challenges. The contributors to this BPI eBook highlight drug-product formulation concerns and collaborative efforts toward solving the fill–finish conundrum. First, the BioPhorum’s Scott Ewan describes a holistic approach to container–closure integrity and the organization’s work toward developing and expanding upon that approach. Ewan explores how advancing analytical technologies, risk management, and quality by design (QbD) are changing the strategies related to container–closure integrity, which remains a significant aspect…

Translating Inhaled and Nasal Technologies for the Delivery of Biologics

by BPI Contributor

This webcast features: Mark Parry, Technical Director, Intertek Inhaled and nasal delivery platforms have specific applications outside of their traditional uses for asthma/chronic obstructive pulmonary disease (COPD) and seasonal rhinitis/sinusitis: They can offer real advantages for the delivery of therapeutic biologics. During this short presentation, Intertek’s Technical Director, Mark Parry, will provide an overview of currently available technologies and successfully marketed products, with a look at the development challenges that might be encountered — and the solutions that are available…

The Green Imperative: Part One — Life-Cycle Assessment and Sustainability for Single-Use Technologies in the Biopharmaceutical Industry

by Magali Barbaroux, Brian Horowski, Sade Mokuolu, Mark A. Petrich, William Whitford and with the BPSA Sustainability Subcomittee and Bill Flanagan

Much has changed since large-scale single-use biomanufacturing equipment was introduced some 15 years ago. Since then, these materials have become accepted and established in production and downstream bioprocessing. Concerns about the environmental impact of single-use (SU) biomanufacturing equipment have become more prevalent as our environmental awareness has increased and related concerns have become more urgent (1). For example, many recommendations and even laws have emerged regarding plastic convenience packaging and products (2, 3). People have become more sophisticated in appreciating…

Applications of Disposable Technologies for Upstream Bioprocessing

by Shada Warreth

Over the past 10 years, a number of developments in disposable (limited use) and single-use technologies (SUTs) have been made for different bioprocess operations. Until recent years, much of the industry’s process equipment was sterilized using thermal methods such as autoclaving. Most equipment was reusable and required cleaning and sterilization before use. Such processes required validation and expensive and time-consuming resources. Production facilities relied on hard-piped, inflexible equipment such as large stainless-steel bioreactors and holding tanks. However, advanced SUTs now…

Viral-Vectored Gene Therapies: Harnessing Their Potential Through Scalable, Reproducible Manufacturing Processes

by Sue Washer and David R. Knop

We might not associate the jazz queen Ella Fitzgerald with 21st-century gene-based therapies, but the First Lady of Song was on to something back in 1939 when she sang “’T’Ain’t What You Do (It’s the Way That You Do It).” Although demonstrating the safety and efficacy of gene-based therapies in rigorous clinical trials is essential for gaining product approval from regulators, doing the bare minimum is insufficient. The way that such products are produced also matters. Manufacturing processes and protocols…

Process Intensification of Viral-Based Vaccines: Where Are the Bottlenecks?

by Sue Pearson, Alexander Douglas, Piergiuseppe Nestola, Cristina Peixoto and Ricardo Silva

In the current coronavirus pandemic, the ability to scale up and produce viral-based vaccines (attenuated viral vaccines, inactivated viral vaccines, and viral vector vaccines) quickly and in large quantities has never before been more relevant. For viral-based vaccines that can be produced by adherent or suspension cell culture, process intensification — in which cell culture, for example, is optimized to produce higher viral titers using the same process equipment — offers a strategy to produce larger numbers of doses in…