A Chemistry, Manufacturing, and Controls (CMC) Strategy Forum was held in January 2012 in San Francisco, CA, to examine the topic of rapid pharmaceutical product development. The purpose of this meeting was to promote an understanding of how best to increase the speed of product development, focusing on areas that improve chances of regulatory success while lessening the time it takes to get a product through development and onto the market. Participants also sought to identify and discuss the issues that accelerate development and those that hold it back — in hopes of developing a winning formula for global best practices.
The concept of “rapid product development” is usually associated with small companies looking to maximize limited resources and achieve a proof of concept that can lead to codevelopment or out-licensing opportunities. The reality is that all companies — small, medium, and large — are looking for opportunities to speed their development to market. Both industry and regulators have the c...
Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects between groups within an organization can be aggravated by a lack of common terminology and poor data-management practices. Implementing a simple data model based on the ISA-88 standard for batch control can help companies capture process and facility data throughout their product life cycle (
1
). The first half of this two-part article illustrates how translating a process description to a structured electronic format could transform the bioprocessing industry. Seamlessly linking development and manufacturing networks (both internally and externally) throughout a product life cycle not only substantially increases value, but also significantly reduces risk of failure. In part 2, we will examine the architecture in more detail, provide an example of implementing functional applications, and discuss a proof-of-concept prototype.
PRODUCT FOCUS:
BIOPHARMACEUTICALS
PROCESS FOCUS:
MANUFACTURING
WHO SHOU...
+1Over the past decade, significant pressures have threatened the future of many pharmaceutical and biopharmaceutical companies. Increasing drug development costs, declining research and development (R&D) productivity, mounting regulatory setbacks, and looming patent expirations — with fewer blockbuster therapies on the horizon — are collectively challenging many businesses to stay profitable and competitive within the industry. Many companies are intensifying their focus on reducing operating costs, particularly within manufacturing operations. This trend is almost an omnipresent feature of management articles, seminar topics, and even direction from company boards of directors.
Throughout this same period, we have witnessed another trend across our industry. Media coverage of product recalls, contamination issues, drug shortages, and even good manufacturing practice (GMP) settlements is almost weekly. Those are no longer one-off examples. This represents a dramatic and troubling rise in quality issues tha...
After nearly a year of planning, BPI announced the winners of its first awards program on the evening of 9 October 2012, during the BioProcess International Conference. Award finalists, sponsors, and guests joined us for a banquet ceremony in the Providence, RI, Convention Center to honor the 36 finalists for our Decade of BioProcess awards — and announce the 12 winners.
In his welcoming comments to the 150 attendees, BPI publisher Brian Caine noted that “during this decade, the finalists in this room have all championed the bioprocessing industry. Their tireless work ethic, imagination, and enduring vision have enabled the industry to undergo a dramatic transformation, to make incredible technological advances, and essentially rewrite the book on how to develop and manufacture biotherapeutics more effectively and less expensively.
“Because of you, we can better diagnose and treat illnesses and prevent diseases. And although we are here to celebrate your accomplishments tonight, we also celebrate the biot...
Compliance officials have a great deal to worry about. They are judged by results and loaded with stress over the latest changes in government guidance documents and internal budget pressures. They need to continually update their programs to stay abreast of those developments, including revisions that target in-house processes to encourage disclosures from whistleblowers. Failure to provide for such revisions places both a company and individuals at risk
Whistleblower Protection Expanded and Includes Rewards
In response to the financial crisis of 2007–2008, Congress passed the Dodd–Frank Wall Street Reform and Consumer Protection Act in July 2010 (the “Act”). This legislation recognized that many of the ills that sunk the financial system could have been mitigated, if not prevented, if people “in the know” had spoken out. It was also acknowledged that many people refrain from speaking out when doing so could result in retaliation and a loss of their jobs.
PRODUCT FOCUS:
ALL BIOLOGICS
PROCESS FOCUS:
MAN...
IBC’s Biopharmaceutical Development and Production Week provides updates on current and emerging
methods
to improve your bioproduction capabilities and delivers strategies to help you overcome process challenges and accelerate production of the biopharmaceutical industry’s emerging new wave of monoclonal antibodies (MAbs) and novel
molecules
.
Methods
The Monday and Tuesday tracks provide a firm foundation in practical methods and strategies for specific unit operations. This can help you tackle some of the specific challenges in your job function. Implement process validation and continuous verification in the new paradigm. Leverage contract manufacturing and technology transfer for improved bioproduction. Prepare to meet future demands for analytical technologies. Control raw material variability and improve supply chain transparency. Mitigate contamination risk with viral safety strategies to meet regulatory standards.
Molecules
The Wednesday–Friday tracks provide you with the most comprehensive upd...
The biopharmaceutical industry is abuzz with talk regarding a 2011 US Food and Drug Administration (FDA) guidance on human factors and the mitigation of user-based risk in the development of medical devices (
1
). As expected, his talk is often accompanied by a sense of anxiety. Device developers and the growing number of biomanufacturers developing combination drug–device products now need answers to usability questions they are hardly familiar with. Wrong answers may have direct (and troubling) implications from a number of perspectives, such as regulatory approvals to business-case success and innovation.
Understanding the scope, depth, and nuance of human factors engineering and design for usability requires expert practitioners — those experienced in both the science and art of understanding human capabilities and limitations within a constantly changing regulatory framework. Thankfully for the rest of the drug delivery community, a better understanding of what this means for the development process ...
Cold-Chain Tracking
Product:
PakSense BIOmed XpressPDF package label
Applications:
Drugs, vaccines, and other temperature-sensitive biologics
Features:
Calibrated to NIST standards, PakSense BIOmed XpressPDF labels help companies monitor and record product package temperatures. The size of a sugar packet, each waterproof label features a USB connection that automatically generates PDF files. Unlike bulky recorders that read ambient conditions, a label sensor measures the temperature of the surface on which it is attached once a minute. Results can be read at a glance (LEDs indicate when a breach has occurred). These labels fit inside shipping containers to maximize cargo loads.
Contact Cold Chain Technologies
www.coldchaintech.com
Australian CMO
Service:
Contract manufacturing based on mammalian cell expression
Applications:
Antibodies and other complex proteins
Features:
In mid-2013, DSM will open an 8,000-m
2
contract manufacturing facility in Brisbane, Australia. Its ≤500 kg/year capacity will c...
The importance of the Centers for Disease Control and Prevention (CDC,
www.cdc.gov
) in the tracking and treatment of viruses such as the influenza virus cannot be underestimated. It is a first line of defense against an influenza pandemic as well as a way to analyze seasonal influenza outbreaks to make certain that they do not deviate from their normal seasonal and geographic patterns.
The CDC seeks to communicate with the American public through a wide variety of media. To its credit, as part of its communication program, the CDC emphasizes communicating with nonmedical citizens as well as medical personnel. iMedSocial reviewed the CDC’s ability to effectively communicate with the general (not medically trained) American public. How effective are the communication programs of the CDC in communicating important information about influenza to the average citizen? Unfortunately, the answer is “not very.”
As part of our analysis, we looked at several time periods: from 1 September 2011 to 31 March 2012 (pr...
