Once upon a time, this was the way of things: Most projects happened in-house, or at least locally, and the activities they required weren’t very complicated. In today’s global business environment, however, the days of such simplicity are gone. Instead, now the “+1” person in the
N
+ 1 equation (see the box at right) is the glue that holds complex, global activities together for a company. That person is the project manager.
Simply stated,
project management
(PM) is the management of people, activities, time, and money toward the successful completion of a stated goal. That sounds easy, and we do it all the time in our daily lives. But it is imperative in the complex world of biopharmaceuticals to have a single point person responsible for ensuring that all the pieces of a project come together efficiently, effectively, and on schedule.
Picture This:
First, consider the management of people. Imagine you are team leader of a group responsible for delivering a phase 1 clinical trial antibody product. ...
Mergers and acquisitions have long been a staple of the life sciences industry — a reality that has resulted in disparate information technology (IT) environments within and across often far-flung enterprises. The situation is particularly prevalent in manufacturing operations because a pharmaceutical or biotechnology organization may run different management systems in nearly every separate facility (especially when contract manufacturers are involved). These “siloed” information environments are hindering efforts to evaluate and improve quality and operational efficiency at a time when quality and efficiency are most important to life-science executives.
One way to solve the problem is to implement a single IT application across all manufacturing plants. But that is risky, expensive, and time consuming — if at all feasible given good manufacturing practice (GMP) and validation requirements as well as business pressures. Biomanufacturers, therefore, seek strategies and tools to help them make the most of...
Certain types of quality control (QC) testing are often outsourced by pharmaceutical companies, regardless of an organization’s size — typically because the company is either incapable of performing the assays in-house or does not wish to bring them into its facility. The decision to outsource may be based on
Examples of contracted testing include viral and mycoplasma safety studies with infectious positive control organisms, analytical testing using highly specialized equipment such as inductively coupled plasma mass spectrometry (ICP-MS) or inductively coupled plasma atomic emission spectroscopy (ICP-OES), and radiolabeling studies for metabolism or biodistribution. Fortunately, a number of contract research and testing organizations can and will perform such types of testing.
The wrong way to manage a contract laboratory ()
Much has been written about the rationales for and advantages of outsourcing manufacturing and/or testing services, selecting outsourcing partners, and optimizing sponsor/contractor...
Flexibility
has quickly become one of the most noticeable buzzwords of the bioprocessing industry. Understanding what constitutes a “flexible” process ranges from the simple application of one specific type of technology (e.g., single-use systems, automation, standard controls) to a somewhat extreme concept of a “throw-away” process. But whatever the definition, the factors leading to the need for more flexible approaches to biomanufacture are clear: Rapid, sometimes unexpected, changes in a company’s business situation and/or product portfolio (whether for patients or clinical trials) require that companies adjust to meet those challenges in very short time.
Achieving Flexibility
Although blockbusters are still dominating current markets, biopharmaceutical companies have been quietly shifting from the blockbuster model to diversified portfolios with big and small products on the horizon. To develop those products, manufacturers have been forced into a position of having to introduce flexibility into the...
When bioprocess liquids bearing suspended particles are filtered, retained particles can block and clog membrane filter pores. The pore size rating of a filter should be selected to retain objectionable particles by sieving, and the aptitude of its polymeric composition for adsorptive sequestration of those particulates also needs to be known. The quantity and nature of retained particles require accommodation if filtrative removal is to be considered successful. Too extensive a particle load will prematurely block a filter’s delivery of sufficient throughput to meet the filtration’s goal: obtaining enough drug product to provide an adequate monetary return. Drug processing thus represents a technoeconomic challenge.
In the first half of this two-part article (
1
), we examined fluid effects and operations (particle load; interactions of filtration area, differential pressure, and processing time; and operating conditions) as well as reviewed the results of several experiments involving latex particles an...
+1Biomanufacturers face a conflict between low-cost generic host cell protein (HCP) assays and highly sensitive but more costly process-specific HCP assays that are usually not initiated until the proof-of-concept stage. But drug developers cannot expect sufficient sensitivity from most commercially available generic assays. For some companies, multiproduct HCP assays could offer a solution to the dilemma.
Biopharmaceutical manufacture using genetically modified microorganisms and cell lines is typically associated with contamination by process-related impurities. One of the most important contaminations during product development and production of biopharmaceuticals is HCPs originating from the production cell line. HCPs are inherent to all production processes relying on bacterial, yeast, or mammalian cell culture, and they can reduce drug efficacy and even delay or kill promising drug candidates through adverse patient reactions.
PRODUCT FOCUS:
PROTEINS (PRODUCTS OF CELL CULTURE AND FERMENTATION)
PROCES...
Optimized upstream processing and high-productivity cell culture increase not only target protein titers, but also impurity and contaminant concentrations to be removed from large volumes of feedstock. Simultaneously, biopharmaceutical drug production is increasingly driven by manufacturing cost reduction. These facts together increase the pressure on downstream processing and create an urgent need for more productive and streamlined chromatography operations. Key parameters to consider for enhanced process economics in chromatography are higher protein binding capacities at high flow rates (to reduce batch processing duration) and improved sorbent selectivities (to reduce the number of column chromatography steps and decrease purification cost).
Ion-exchange (IEX) chromatography is one of the most broadly used techniques for protein purification. Protein binding during ion exchange is driven by a combination of factors including primarily
PRODUCT FOCUS:
PROTEINS
PROCESS FOCUS:
DOWNSTREAM PROCESSING
WHO...
+1 Stem Cell Harvesting
Product:
CellCelector stem cell picker
Applications:
Stem cell projects
Features:
Through its distribution agreement with AVISO GmbH, TAP offers the CellCelector automated stem cell picker to the US, Canadian, Irish, and UK markets. The noninvasive system automates selection and harvesting of murine and human stem cells to reduce associated time and costs in research and development. Lifelike images of cells before harvest allow users to document and standardize the quality of cells chosen. The system compliments TAP’s CompacT SelecT automated cell culture system.
Contact The Automation Partnership
www.automationpartnership.com
Disposable Fluid Control
Product:
Large tube clamp
Applications:
Single-use fluid management
Features:
Advanced Scientifics has developed a large tube clamp for controlling or stopping the flow of a fluid path through 0.75–1.75 in. outer diameter (OD) tubing (0.125-in. wall). This component includes a simple, secure locking and unlocking feature for versa...
Many companies are adopting single-use technologies. This program begins with a workshop that showcases the cutting-edge implementation experience of CMOs and start-up companies. The complete program includes the latest case studies and strategies for single-use bioprocessing, including development of a fully disposable downstream train, disposable bioreactors and sensors, and other components. Validation for applications involving the reduction of extractables, leachables, endotoxins, particles, and other risk factors will be explained. A shared session with the colocated vaccine conference gives an in-depth look at the use of disposables in vaccine production. Vaccine manufacturers are cutting-edge early adapters of single-use technologies.
Hear how leaders in the field are increasing manufacturing flexibility, developing products faster and at lower cost, enabling multiuse facilities, accelerating turn-around times, and reducing validation efforts. Catch an FDA update on regultory review of single-use ...
In our February 2010 special report, “The Time Has Come for Automation in Bioprocessing,” one theme that made itself clear was the need for vendors, biopharmaceutical companies, and sometimes even regulators to work together toward the goal of better, faster, and cheaper product development through (among other things) automation technologies. Martin Rhiel of Novaris cell and process R&D told us, “It would be really nice to just buy it and implement it, but this doesn’t always work…Nowadays, the FDA is working together with pharmaceutical companies in implementing new technologies.”
Case in Point
In November 2009, Caliper Life Sciences, Inc. was invited to present a training session for about 75 reviewers from the FDA. A month later, BPI contributing editor Lorna McLeod spoke with Caliper’s CEO Kevin Hrusovsky about the new technology.
BPI:
How did the FDA training session go?
Hrusovsky:
It was standing room only attendance. We described the role that our new LabChip GX product can play in supporting Qb...
