Manufacturing

eBook: Continuous Bioprocessing — Promises and Challenges

Biotechnological productions are commonly executed as batch processes, especially during downstream processing. Higher titers in fermentations, reductions in operating scale, and the quest for improving product quality all have led to an intensified effort for developing continuous processing. It is forecasted that within the next 10 years, about 50% of all drugs under development will be biopharmaceuticals, making it worthwhile to develop more efficient processes. In this BPI eBook, Babu Halan (project engineer) and Wolfgang Minas (global lead of the…

From Big Data to Precise Understanding: The Quest for Meaningful Information

High-throughput technologies have transformed the biotechnology industry. The amount of data they generate is at least a hundred times higher now than it was two decades ago, primarily because of the rise of “-omic” technologies. As in many other industries, the biopharmaceutical sector entered the era of big data the day that high-throughput analytics were routinely implemented in experimental research. Big data refers to “datasets with sizes beyond the ability of commonly used software tools to capture, curate, manage, and…

Ask the Expert: Accelerating Timelines By Integrating Cell-Line Development and Manufacturing

In a 31 October 2019 “Ask the Expert” presentation, Nicole Wakes (group leader of Abzena’s cell-line development team) observed that drug sponsors often outsource their early upstream activities to a few different contract research organizations (CROs). But that strategy can thwart short timelines and introduce regulatory and financial risks. Wakes described Abzena’s upstream approach, illustrating how partnering with a single, multicompetent CRO from cell line construction through manufacture can streamline workflows. Integrating cell line development and manufacturing in this way…

Ask the Expert: Developing Bioprocesses for Clinical Manufacturing Success

Biopharmaceutical companies need to make critical chemistry, manufacturing, and controls (CMC) decisions during clinical development of recombinant protein biologics and advanced therapies. In a 17 December 2019 “Ask the Expert” webinar, Nigel Shipston (director of program design at FUJIFILM Diosynth Biotechnologies, FDB) reviewed key aspects of selecting and working with a contract development and manufacturing organization (CDMO). He also highlighted important factors that should be considered during early stages of process development. Shipston’s Presentation The sheer magnitude of investment required…

Bioengineering for “Benchtop Clinical Trials”

Animal studies can be poor predictors of human drug response. Species-specificity of organs is a concern especially for the heart. Many drugs that enter clinical trials will fail ultimately because of unexpected cardiotoxicity. Drug developers would love to mitigate such risks through in vitro human cardiac testing, but human heart biopsy materials and donor organs do not survive well in a laboratory setting. Breakthroughs with human stem cells offer an alternative. It is now possible to take a simple skin…

Challenges and Opportunities in CAR T-Cell Development and Manufacturing

Just about anyone in the biopharmaceutical industry will tell you that cost is now the primary concern in cell and gene therapy development. It hasn’t even been a decade since “manufacturability” was the main issue at hand — and cost has risen organically from related discussions. Regenerative medicine evolved from medical research rather than from drug-development companies, and technologies that worked in clinical settings haven’t translated directly to manufacturing facilities. Cost is often the problem. Early product successes (that ultimately…

Do We Need Separate Regulations for Advanced Therapies?

Before we had the 21 CFR 1271 regulation for tissue therapies, the US Food and Drug Administration (FDA) had determined that regenerative medicine was exceptional enough to warrant its own regulations for good manufacturing practice (GMP). Since 2001, the tissue industry has adapted to those new rules while the FDA stepped up enforcement over time. When a cell or tissue product is regulated under 21 CFR 1271, its specific regulations apply before the general regulations for biologics and drugs. But…

CAR-T at the Crossroads: Is Allogeneic the Way to Go?

As cell therapies move through the clinic toward commercialization, respondents to an Informa Connect industry survey are beginning to look to allogeneic — or off-the-shelf — products as “the next big thing.” Almost 200 people contributed to the Cell Therapy Analytics Report, revealing their current positions within the burgeoning cell and gene therapy space and offering their thoughts and predictions for the future. Most survey respondents work within companies developing oncology products. Of those, the largest group (41%) said that…

eBook: Viral Vectors for Vaccines — A Virtual Conversation on Production and Analysis

Although today’s vaccines are safer, more effective, and more accessible than they were even 20 years ago, the emergence of new, complex pathogens has exposed limitations in traditional vaccine strategies. Viral vector vaccines (VVVs) hold great promise for confronting those now-intractable pathogens. Combining the best features of live-attenuated and DNA-vaccine approaches, these next-generation prophylactics seek to harness the infectivity of non- or low-immunogenicity viruses to shuttle antigen-encoding DNA from target pathogens into host cells. The resulting transduced cells then initiate…

The Proof Is in the Data: Extractables and Leachables

Extractables and leachables (E&Ls) must be addressed in material and process validation programs. Extractables are compounds that can be extracted from a material in the presence of solvents with varying polarity under extreme conditions. Materials manufacturers should make extractables guides available to end users. Leachables are compounds that migrate from a material in the presence of an actual formulation under normal process operating conditions. Extractables information can be helpful as a basis for evaluation of potential process-equipment–related leachables (PERLs)testing. However,…