A regulatory perspective on continuous perfusion production of rFVIII

Continuous perfusion production has enabled flexible manufacturing of rFVIII, a large complex Biotech Product, for over two decades. Continuous improvement has driven frequent process, equipment and facility changes successfully performed utilizing comparability exercises. Challenges in evaluating changes made to a continuous perfusion process includes assessment of impact to quality product attributes throughout the entire fermentation campaign which can be months in duration. Examples of process changes requiring more studies, those successfully supported by small scale development runs and API commercial characterization and an example resulting in non-implementation will be reviewed. Impact of changing Regulatory Environment on submission package requests will be discussed

Alternative business models for forest - dependent communities in Africa: A pragmatic consideration of small - scale enterprises and a path forward

The dominant mode of business practice in the African forest sector – especially in the high forest cover regions – comes in the form of concessionaires operating on publicly held lands. Increasingly, however, the concession - based model is being challenged. Is it socially and environmentally sustainable? Does it lead to positive socio - economic outcomes for forest - dependent communities? While this paper does not attempt to answer these questions head - on, it does put forward four alternative business models that could serve to reduce poverty and improve social conditions among rural forest - dwelling Africans: 1) small and medium - sized enterprises; 2) community forest enterprises; 3) business associations; and 4) alliances with concessionaires. Definitions of the four business models are provided, and some key considerations for each are discussed. The paper concludes by providing recommendations for civil society, governments, economic actors, communities, and other stakeholders interested in catalyzing and creating an enabling environment for these sorts of business alternatives to succeed in the forested regions of Africa. Namely, there is a need to collect and disseminate quantitative data on the socio - economic contributions that small - scale enterprises can make, devise appropriate interventions that take into account the highly variable socio - political landscapes of Africa, and develop business plans grounded in solid, marketable value propositions

A Little Chapter on the Big Picture

Publisher Copyright: © 2023 selection and editorial matter, Dalia D‘Amato, Anne Toppinen and Robert Kozak; individual chapters, the contributors.Businesses are extractive in nature, reliant on the bounty of natural capital and related ecosystem services that our planet offers. Equally perplexing is the role that governance and policy mechanisms play in fostering an enabling environment for sustainable businesses to thrive. The past decades have seen an undeniable shift towards the use of private sector policy innovations, like finance- and market-driven tools and third-party certification schemes, being utilised to address critical issues related to environmental degradation and the overall health of our planet, as articulated in the United Nations Sustainable Development Goals. Results have been, at best, mixed in terms of curbing global deforestation, emissions, or environmental degradation, even when these efforts are part of larger governmental or intergovernmental initiatives. One mechanism that shows a good deal of promise is the hybrid organisation. These are businesses with a societal purpose, which focus not on profit maximisation, but on creating a meaningful sustainability orientation.Peer reviewe

Sustainable Futures and the Changing Role of Business in Society

Publisher Copyright: © 2023 selection and editorial matter, Dalia D‘Amato, Anne Toppinen and Robert Kozak; individual chapters, the contributors.Drawing from the lessons penned in the chapters of this book by international scholars and practitioners, we offer some final reflections on the role of business in the broader context of a rapidly changing society. We focus on the elements that emerge and recur in several chapters, including key theoretical approaches and core areas of tension around the role of business in sustainability transformations.Peer reviewe

How Specifiers Learn About Structural Materials

Many wood products are underutilized in the construction of nonresidential buildings. To understand better why this is so, a mail survey was conducted in both Canada and the United States to determine how specifiers (arcitects and structural engineers) learn about building materials.Results indicate that, while architectural schools spend an adequate amount of time teaching students about timber design, engineering schools devote little time to teaching wood use as compared to time spent teaching students about steel and concrete. This is despite the fact that over 60% of the specifiers who work on buildings less than five stories in height have designed with wood. However, much of the learning about materials occurs on the job, where the most effective means of education include reading materials, data files, manuals, cororate promotion, and word of mouth. Specifiers who do not currently use wood are likely to be most influenced to do so through the use of physical examples such as demonstration buildings and case studies.Long-term cooperative programs, including lobbying efforts and promotional campaigns, are needed to ensure that material specifiers have the knowledge and training required to be able to use traditional and new wood products that are ideally suited for nonresidential construction in North America

Reliability Testing of Statistical Process Control Procedures for Manufacturing with Multiple Sources of Variation

Quality inconsistencies can be caused by processes with multiple sources of variation. Therefore, the development of control charts that perform properly for both producer's and consumer's risk can be very complex. This is particularly true for real-time SPC systems that collect a great deal of data through noncontact sensing. In this paper, we demonstrate the use of a Monte Carlo simulation procedure that can be used to test SPC charts for both consumer's and producer's risk, and an experimental design procedure to analyze the results. This procedure is shown to be especially useful where design factors interact to cause high variation in a quality characteristic of a product. The approach is illustrated for a practical problem taken from the lumber manufacturing industry and demonstrates that commonly used industrial practices to control product dimensions lead to erroneous conclusions. To that end, a new mathematical approach that yields the correct results is described. The Simulation / ANOVA procedure described in this paper may have applicability in the control of many other industrial processes

SPC Methods for Detecting Simple Sawing Defects Using Real-Time Laser Range Sensor Data

Effective statistical process control (SPC) procedures can greatly enhance product value and yield in the lumber industry, ensuring accuracy and minimum waste. To this end, many mills are implementing automated real-time SPC with non-contact laser range sensors (LRS). These systems have, thus far, had only limited success because of frequent false alarms and have led to tolerances being set excessively wide and real problems being missed. Current SPC algorithms are based on manual sampling methods and, consequently, are not appropriate for the volume of data generated by real-time systems. The objective of this research was to establish a system for real-time LRS size control data for automated lumber manufacturing. An SPC system was developed that incorporated multi-sensor data, and new SPC charts were developed that went beyond traditional size control methods, simultaneously monitoring multiple surfaces and specifically targeting common sawing defects. In this paper, eleven candidate control charts were evaluated. Traditional X-bar and range charts are suggested, which were explicitly developed to take into account the components of variance in the model. Applying these methods will lead to process improvements for sawmills using automated quality control systems, so that machines producing defective material can be identified and prompt repairs made

Statistical Considerations for Real-Time Size Control Systems in Wood Products Manufacturing

Currently, sawmill machinery companies are developing real-time size lumber size control systems using non-contact laser measuring systems. These systems rely on the application of industrial statistics to large quantities of lumber thickness and width data. Because of the sampling intensity and frequent decision making in real-time systems, there is an increased chance of committing Type I or Type II errors when drawing conclusions if statistical methods are incorrectly applied. There is confusion in the industry concerning the appropriate statistical model to use for lumber size control. This survey of the current literature discusses three distinct methods for calculating and partitioning sawing variation, and thereby calculating control limits for control charts. This paper reviews the statistical foundation and current understanding of industrial statistics for implementing real-time SPC systems and makes recommendations for improvement

Thermal Modification of Color in Red Alder Veneer. I. Effects of Temperature, Heating Time, and Wood Type

Red alder has become one of the most widely traded hardwood species in North America, and sliced red alder veneer is commonly applied as a decorative overlay on composite wood panels used by the furniture and cabinet industries. Red alder wood, however, acquires a mottled orange color following felling, which is undesirable when the wood is used for decorative purposes. Heating red alder wood remedies this problem to some extent, but there is still an unacceptable level of variability in the color of veneer sliced from heated veneer cants. This study examined the variation in color of red alder wood samples cut sequentially from the pith to the bark and subjected to heating under isothermal conditions. The aim was to examine whether within-tree variation in the susceptibility of red alder wood to thermal darkening can explain variation in color of veneer sliced from steamed red alder cants, and to determine the optimal thermal treatment (temperature and time) that can impart the tan color to red alder wood that industry is seeking. Results indicated that there was within-tree variation in the color of red alder samples following thermal treatment, but differences were pronounced only when wood was heated at a low temperature. Wood close to the bark tended to be redder than wood close to the pith when heated at 30°C, but such a difference was absent in wood heated at higher temperatures (50-90°C). Heating red alder wood, in vitro, at 70°C for 36 h produced wood that was evenly colored from pith to bark and matched the current industry color preference. It is suggested that the color of thermally modified red alder wood depends on the strength of reactions that produce orange/red chromophores in the wood, thermal darkening of the wood, and destruction of orange/red chromophores