Small-molecule treatments are invaluable in providing symptomatic benefits for an array of illnesses. However, many serious conditions — ranging from cancer to autoimmune disorders — respond better to more sophisticated complex drugs such as therapeutic biologics and nonbiologic complex drugs (NBCDs). The latter are medicinal, nonbiological products in which the active substance is not a homomolecular structure, but rather consists of a number of different (closely related) structures that cannot be fully characterized. The US Food and Drug Administration (FDA) defines a therapeutic biologic as “a protein derived from living material (such as cells or tissues) used to treat or cure disease” (
1
).
Until recently, pharmaceutical companies in the United States had no procedure to follow when submitting applications for “generic” or follow-on versions of biologic drugs (now called biosimilars). And still, no clear guidelines are available for NBCDs. Despite expiring patents on biologics, this was a complicat...
Compliant companies, to paraphrase Tolstoy, are all alike. Every noncompliant company seems to find its own way to fall short of compliance with good manufacturing practice (GMP) and come, as did the writer’s famous heroine Anna Karenina, to grief. One commonality of compliant firms is that most seem to have excellent self-auditing/self-inspection programs. Indeed, many inspectors say that a primary predictor of a compliant company is a rigorous self-inspection program. Such a program is appropriately focused, adequately resourced, taken seriously by management, and not only discovers incipient compliance problems, but follows up by implementing effective corrective and preventive actions (CAPAs). Another common feature of happily compliant companies is an excellent regulatory intelligence (RI) system that provides the knowledge needed to stay on track in the dynamic regulatory environment
In a previous article (
1
), I provided a primer on lessons that can be learned by studying and analyzing FDA notices...
It’s official: The “Age of Cell Therapy” has arrived. A robust pipeline of cell therapies, with increasing numbers of both early- and late-stage clinical trials as well as FDA-approved commercial products that have entered the market already, strongly indicates that the cell therapy industry is poised to emerge as a distinct healthcare sector (
1
). Renewed investor interest and recent activity among major pharmaceutical companies suggest that this industry will rapidly develop the capability and capacity to be a highly competitive, sustainable, multibillion-dollar enterprise. But when commercialization comes, will companies be ready to meet the enormous demand for viable cells?
PRODUCT FOCUS:
Cell therapies
PROCESS FOCUS:
Manufacturing
WHO SHOULD READ:
Process and product development
KEYWORDS:
Automation, scale-up, disposables, cell culture, formulation
LEVEL:
INTERMEDIATE
The maturing field of automated cell cultivation using highly specialized bioreactor designs and stringent bioprocess controls w...
Single-use (disposable) technologies are gaining significant traction in biopharmaceutical manufacturing due to reductions in capital investment for plant construction, lower requirements for cleaning and sterilization, and the advantages of eliminating cross-contamination during multiproduct manufacturing (
1
,
2
,
3
,
4
). In the early days of disposables, single-use (SU) systems were used only in specific unit operations (
5
,
6
). Recently, however, options have become more widely available throughout drug-substance manufacturing (
7
,
8
,
9
,
10
). Companies now focus on selecting the right SU technology from an array of options and integrating those choices into production processes.
PRODUCT FOCUS:
ALL BIOLOGICS
PROCESS FOCUS:
Manufacturing
WHO SHOULD READ:
MANUFACTURING, PROCESS DEVELOPMENT, facilities
KEYWORDS:
DISPOSABLES, bioreactors, chromatography, filtration, inoculum, centrifugation, storage, freeze–thaw
LEVEL:
Intermediate
KBI Biopharma operates an end-to-end current good manufacturin...
+2Biopharmaceutical contract services have seen some very important changes and growth in recent years, part of an increasing trend toward outsourcing by pharmaceutical companies both large and small. And we have seen a significant change in the types of services demanded by clients. In addition to typical services such as validation, analytical services, and training, for example, demand has increased for outsourcing of process development, mammalian cell culture, good manufacturing practice (GMP) production, and final formulation and filling. Those demands have presented a substantial challenge for contract service companies to provide integrated services together with flexible and adaptable facilities for multiproduct capability in both upstream and downstream processing. As always, timelines are expected to be as short as possible, with rapid product changeover, effective cleaning procedures, and lowest possible costs.
PRODUCT FOCUS:
ALL BIOLOGICS
PROCESS FOCUS:
MANUFACTURING
WHO SHOULD READ:
PROCESS...
+1 Sterilizing filtration renders biotherapeutics free of biocontamination. In many cases, sterilizing-grade filters also reduce bioburden or facilitate closed or aseptic processing. They are used to filter active pharmaceutical ingredients (APIs), formulated bulk, cell culture media, buffer, additives, process intermediates, and so on. Such applications are often critical for ensuring a successful batch operations.
Nonetheless, a significant amount of time and resources are typically not devoted to establishing filter sizing requirements for “simple” applications such as buffer filtration. Here, we provide a sizing tool to help you estimate filter-size requirements for simple filtration applications. Specifically, we describe of a simple generic sizing tool (
K
Buf
sizing constant) for three different sterilizing-grade filters developed using a generic value of permeability for buffer filtration. We include a quick reference chart for different filters to estimate filter-sizing requirements for fairly nonp...
+1 Over the years, bioprocessing companies have leveraged a host of information technology (IT) to help them bring innovative new therapies to market. As the needs of a research and development (R&D) enterprise evolve, however, are such systems and applications a help or a hindrance? On one hand, the increasing sophistication of IT solutions — such as those designed to help users create advanced molecular models or track thousands of compounds through the discovery process — have enabled new levels of R&D innovation. On the other hand, at some point the law of diminishing returns kicks in as more resources and budgets become devoted to maintaining IT infrastructure (e.g., integrating information from different systems and databases and training people to use multiple applications).
Ultimately, organizations focused on developing new therapies need to be able to extract maximum value from their R&D data without overspending on informatics infrastructure that’s too cumbersome and inefficient. It’s at this poin...
Fluid Management
Product:
BioFlex tubing
Applications:
Single-use bioprocessing
Features:
Meissner’s BioFlex tubing assemblies provide secure fluid paths for single-use systems and scale to allow flow rates >100 L/min. The tubing also connects disposable and stainless steel process equipment. Customizable assemblies can integrate sterilizing-grade through clarification-grade capsule filters. BioFlex products come sterile and ready to use, incorporating required tubing materials, connectors, filters, pinch clamps and other specified components. Pre- and postuse integrity testing procedures also can be accommodated.
Contact
Meissner Filtration Products, Inc.
www.meissner.com
Cell Culture Monitoring
Product:
samX acoustic biosensor
Applications:
Mammalian cell culture
Features:
Biosensors in the sam series feature eight analysis channels and adaptable microfluidic routing for studying real-time kinetics on the surfaces of live mammalian cells. The samX system uses Surface Acoustic Wave technologies t...
As the biopharmaceutical industry in China continues to grow, the corresponding demand for high-quality, tactical information and proven strategies continues to increase. Although many people see China’s current technologies and skillsets as lagging behind those of more advanced counterparts in North America, Europe, and Asia, the Chinese industry’s thirst for knowledge and eagerness to adopt and adapt new techniques have enabled it to leap-frog development at an astonishing speed.
At IBC’s fourth annual BioProcess International China event, the goal is to bring China and the rest of the world together to explore gaps in development and help bring China up to speed on critical topics such as cell-line engineering, culture media development, analytical characterization strategies (to establish similarity between biosimilar and originator drugs), and design of multiproduct facilities with implementation of single-use systems.
Meet experts from both Europe and the United States who have proven success storie...
Experts in synthetic biology research, law, ethics, and social science from more than a dozen institutions gathered at the Woodrow Wilson International Center in Washington, DC, on 8–9 November 2010 to discuss “Societal Issues Arising from Synthetic Biology: What Lies Ahead.” The workshop was organized by the Department of Energy’s Office of Biological and Environmental Research and the Alfred P. Sloan Foundation. After plenary presentations on the first day, almost 70 participants broke into groups to discuss potential applications of synthetic biology as well as societal challenges and pressing research needs. As summarized in the closing remarks, the potential challenges and benefits of this technology must be managed with caution and the benefits justly distributed. As with genetic engineering, wise regulations can maximize benefits and minimize risks, and a responsible mind-set is required for everyone involved.
Plenary Speakers
John Glass of the J. Craig Venter Institute opened the workshop presenti...
