ERT 455 MANUFACTURING & PRODUCTION OF BIOLOGICAL PRODUCT

ERT 455 MANUFACTURING & PRODUCTION OF BIOLOGICAL PRODUCT LECTURES: CIK MUNIRA BT MOHAMED NAZARI PROF. MADYA DR. DACHYAR ARBAIN

PRESENTATION OUTLINE • Teaching Plan • Refreshing Slot • Introduction to Manufacturing and General Calculation ERT 455 Session 2011/2012

“ Is the process of converting raw materials into products; it encompasses the design and manufacturing of goods using various production methods and techniques.” Manufacturing?? ERT 455 Session 2011/2012

Production?? Production is a process of converting inputs in to outputs. In production, the raw material is not procured from outside, the company owns it and after processing and make the final product. In Manufacturing, the company procures the raw material from outside, and then makes the final product. manufacturing is a process of converting raw material in to finished product by using various processes, machines and energy. ERT 455 Session 2011/2012

Biological Product Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. ERT 455 Session 2011/2012

INTRODUCTION TO MANUFACTURING ERT 455 Session 2011/2012

Design & Development of Biological Product • Consist of four phases Phase 3 Phase 4 Phase 2 Phase 1 ERT 455 Session 2011/2012

Design & Development of Biological Product P H A S E 1 ERT 455 Session 2011/2012

Design & Development of Biological Product Look Around • To become a product developer, an interest in product must develop. We must learn to look around, to find out how things work, and to find ways of improving them. • Examples: ERT 455 Session 2011/2012

Design & Development of Biological Product Example 1 – Marker How it’s can make a nice picture on a piece of paper, the marks are translucent, and they have about the same thickness everywhere. Example 2 –Toothpaste Look like a solid but liquid when sheared. It stays on a toothbrush as a little white sausage. It contains a large fraction of fine solid particles, as we find out by diluting with water and vinegar. The particles (which are mildly abrasive) are smaller than 30µm. So, how could we get toothpaste to be effective in the crevices between the teeth where it really is necessary? ERT 455 Session 2011/2012

Design & Development of Biological Product • Common Factors of Products This was a diverse set of products, coming from a number of industries and using many different technologies. You might wonder whether they have anything in common: they do. They even have a common name: all are formulated products. Formulated products are not simple chemical. They always consists of several, and often many components. Each of these has a purpose and most formulated products have a micro or nano structure that is important for their function. However, obtaining this structure often the big challenge. ERT 455 Session 2011/2012

Design & Development of Biological Product • Product Development Developing a new product is quite an undertaking. It usually requires years of work and large amount of cost to be invest. In this process, it is never done by a single person; one needs more people, often large number. Figure 1.1 shows the characteristic of product development and how people work together will be discusses on the Team Up lesson. ERT 455 Session 2011/2012

Design & Development of Biological Product ERT 455 Session 2011/2012

Design & Development of Biological Product Team Up • You can seldom develop a product alone, so you need an organization. • There are three types of organization that you will signed up, which are; • Functional Organizations • Project Organizations • Matrix Organizations (mix) ERT 455 Session 2011/2012

General Manager Design & Development of Biological Product Functional Managers • Functional Organizations • People are organized by function. Important functions in a product company are design, manufacturing and marketing. • Functional organizations are usually hierarchical, where each person reports to his boss. ERT 455 Session 2011/2012

Design & Development of Biological Product • Functional Organizations • Focuses on activities that are done continuously – long term functions. • It is good for repetitive work such as manufacturing. • In such an organization, people are grouped as marketers in a marketing department, as manufacturing engineers in manufacturing, and so on. • This allows people to learn specialist knowledge from each other and become experts in their field. • Examples: Universities, ministries and oil refinery. • Functional organizations are stable and reliable, and allow development of expertise. However, they are too slow for product development. ERT 455 Session 2011/2012

Design & Development of Biological Product General Manager • Project Organizations • People are organized by a project. A project organization would be make up of groups of people from several different functions, with each group focused on development of a specific product, • These groups would each report to an experienced project manager. Project Managers ERT 455 Session 2011/2012

Design & Development of Biological Product • Project Organizations • Focuses on temporary activities: it is aimed at the short term project. Good for a new things, for change. • People in project teams learn to be flexible. • Example: building corporations and engineering contractors. • Project organizations are flexible and renewing, but can lead to chaos. ERT 455 Session 2011/2012

Design & Development of Biological Product • Matrix Organizations • Most firm try to obtain advantages of both functional and project organizations – mixed organization. • Individuals are linked to others according to both project they work on and their function. Typically each individual has two supervisors, one a project manager and one a functional manager. • Two types: • Lightweight Project Matrix Organization, and • Heavyweight Project Matrix Organization. • In both types of matrix organization, assignment of personnel to temporary jobs is a source of friction. • Active management is required to maintain a balance. ERT 455 Session 2011/2012

Functional Managers General Manager Design & Development of Biological Product Functional Managers Lightweight Project Manager General Manager • Matrix Organizations Heavyweight Project Manager Lightweight Project Matrix Organization Heavyweight Project Matrix Organization ERT 455 Session 2011/2012

Design & Development of Biological Product Get a Method ERT 455 Session 2011/2012

Design & Development of Biological Product Analyze the Situation ERT 455 Session 2011/2012

Design & Development of Biological Product • Get Some Order 1) Set up a documentation system. 2) Start collecting information. 3) Consider where, by whom and how the product is to be used. 4) Collect ideas on required performance. i. How well does the textile have to be cleaned? ii. Which kinds of dirt have to be considered? iii. Is the product safe? iv. What happens with the product and dirt? 5) Analyze how existing products work and how they interact with the surroundings. i. Construct a tree diagram of the subject to keep an overview (Figure 4.10). ii. Analyze by splitting problem (Figure 4.11). ERT 455 Session 2011/2012

Design & Development of Biological Product Figure 4.11 shows some splits we have considered here. The methods in the left side are mostly related to devices and those in the right side to matter. However, this division is seldom straightforward. You will have realized that understanding detergent powder (matter) requires understanding of the washing machine (device). ERT 455 Session 2011/2012

Design & Development of Biological Product P H A S E 2 ERT 455 Session 2011/2012

Design & Development of Biological Product Find Needs ERT 455 Session 2011/2012

Design & Development of Biological Product • After finding customers, we now turn over to assessing the customer needs. The method for this has the following steps: 1) get customer data (mainly via interviews), 2) interpret the data in term of customer needs, ERT 455 Session 2011/2012

Design & Development of Biological Product 3) tidy up the data, 4) group and rank the needs, 5) look back and reconsider the results. ERT 455 Session 2011/2012

Design & Development of Biological Product Specify the Product • To specify what a product is to do, we need to follow below steps; • Begin with the list of needs. • For each of need try to find a metric – something that is measurable and that describes the need quantitatively. • Look around for competing products and determine how well they fulfill the needs; also measure the values of their metrics. • Your new product will have to be better than existing products – this gives you an idea for your first specification. • Making and selecting product concepts. ERT 455 Session 2011/2012

Design & Development of Biological Product • List of Needs ERT 455 Session 2011/2012

Design & Development of Biological Product • Look around for competing products and determine how well they fulfill the needs. ERT 455 Session 2011/2012

Design & Development of Biological Product • Look around for competing products and determine how well they fulfill the needs. • Now, construct a need chart (Figure 6.8), which is just an extension of your former chart.Leave a column to fill in the results for own product later. Give scores for the other competitors. ERT 455 Session 2011/2012

Design & Development of Biological Product Create Concepts ERT 455 Session 2011/2012

Design & Development of Biological Product • Splitting (Decomposing) • The 1st step is to split the problem into sub problems and to analyze sub functions. Focus on sub problems that appear to be critical to the product. ERT 455 Session 2011/2012

Splitting (Decomposing) • The 2nd split is to consider what happens on a non-protected ship (Figure 7.9). This start with a clean skin. Growth probably start with micro-organism adhering to the skin, and forming an environment in which larger organism can grow. From shipping experience you get the impression that growth is serious when a ship is lying still – this suggest that organisms are easily sheared off initially. The impression is that the problem is especially serious in warm waters. How could you influence adhesion? How growth rates? How shearing? ERT 455 Session 2011/2012

Design & Development of Biological Product • Splitting (Decomposing) • A 3rd split looks at the current method of protection (Figure 7.10). We have again jotted down questions that come up. Any of these can leads to ideas for solutions. For example ‘Which substances are we releasing’ leads to whether there might be other, less detrimental ones, perhaps biodegradable. ERT 455 Session 2011/2012

Design & Development of Biological Product • Forming New Concepts • Use the concept tree to tidy up the ideas; • To prune branches of which you have no expectations, • To bring some order in the ideas, • To consider a lack of knowledge of any branch. ERT 455 Session 2011/2012

Design & Development of Biological Product • Forming New Concepts • Brainstorming ERT 455 Session 2011/2012

Design & Development of Biological Product • Forming New Concepts • Combining. The combination of Figure 7.12 and Figure 7.13 gives the ideas to begin with. For the 1st round, we will scrap all nonsense and ‘no-go’ solutions and rearrange the remaining items such that you can see who might work on them. The result for this lesson might look like Figure 7.14. ERT 455 Session 2011/2012

ERT 455 Session 2011/2012

Design & Development of Biological Product Select a Concept • To select the final concept from your list, use the following steps: • Select the general ideas (put the details ones aside) • Scrap the nonsense and no-go ideas, • Arrange remaining ideas in what might become projects. Consider who might be involved in these. • Get more information and briefly work out project plan. • Select using the limited information that you have. • Go into the next round of designing using the same method, and so on until you have a good choice and a rough development plan. • Techniques useful in making choices are engineering estimation and concepts-criteria matrices. ERT 455 Session 2011/2012

ERT 455 MANUFACTURING & PRODUCTION OF BIOLOGICAL PRODUCT