PRACTICAL APPLICATIONS OF BIOTECHNOLOGY



PRACTICAL APPLICATIONS OF BIOTECHNOLOGYBioprocessing technologyUses whole living cells or components of them to manufacture desired products.Most common whole cells used are yeast and bacteria (one-celled organisms).Most common components are enzymes (proteins that catalyze chemical reactions).Cells isolated from animals and plants also are used to produce desired products.2. Genetic engineeringThe technique of removing, modifying or adding genes to a DNA molecule to change the information it contains. More specifically is known as recombinant DNA (rDNA) technology.The product of rDNA technology is known as a genetically modified organism, or GMO.Example: Gene for human insulin inserted into E.coli → bacteria that make human insulin (a biopharmaceutical). 1. Agricultural applications — better crops, improved animal health2. Medical and health care applications — new tests, vaccines, medicines3. Chemical and environmental applications — better manufacturing processes and consumer products1. Agricultural applications — _____________________Improve crop yields by introducing genes that confer __________________________, tolerance to ____________ and _____________ to environmental stresses (drought, heat, cold).Create disease- and insect-resistant trees to help meet demand for wood products. 1. Agricultural applications — _____________________Better detection of ____________More nutritious _________New and more effective ____________Improved _______________ for diseases2. Medical and Health Care Applications________________________________Example: quick test for strep throatMANY new treatments for ______________ and conditionsExamples: _____________, stroke, anemia, cystic fibrosis, hemophilia, leukemia and other _________; hepatitis; rheumatoid arthritis; growth deficiencies; transplant rejection 3. Chemical and EnvironmentalApplications (Industrial Biotechnology)Produce enzymes used in ___________ detergents.Use genetically modified microorganisms that break down _______________________.Develop bio-based, biodegradable plastics.Improve manufacturing that reduces the amount of ________________________. Clinical Trials — A Closer LookThe Food and Drug Administration (FDA) is the main consumer watchdog for numerous products: Drugs and _____________ (prescription and over-the counter), Food, Medical devices, ___________ feed and drugs, Cosmetics, Radiation-emitting products (such as ___________________ and pagers)The evaluation of pharmaceuticals and biopharmaceuticals is a highly _____________ process requiring many _______ to prove a drug is safe and effective.This is known as the drug development process. There are a number of steps in the new drug development timeline.The steps include:? research and _____________ in the lab ? testing in ___________ models (pre-clinical) ? several phases of testing in ___________ (clinical trials)Clinical trials are ____________________ designed to distinguish a drug’s __________ from other influences.Drugs must be thoroughly analyzed and tested in animal models _____________ they are tested in humans.Research and development in the labR&D involves initial synthesis and analysis of a promising pharmaceutical OR development and analysis of a biopharmaceutical produced in living cells. On upcoming slides, the word “drug” applies both to pharmaceuticals and to biopharmaceuticals.Pre-clinical testingWhen new drugs show promise in lab testing, studies are designed to evaluate them further.These studies in animals are referred to as “pre-clinical studies.”Pre-clinical studies help establish ________________ ____________________________ of the treatment if/when human studies begin.Many new drugs and treatments are ______________ at this step because they are proven unsafe.Clinical research and developmentThe application to the FDA to request permission to begin human testing is called an Investigational New Drug application, or IND.The IND permits the use of an investigational new drug for the sole purpose of __________________________.Phase 1 clinical trialsDrug is tested for its _____________ with the human body.Trials are conducted to determine the appropriate dose range with regard to ________ and _____________ (NOT ______________).Trials are conducted on a limited number (___-___) of normal volunteers or patients (such as patients with cancer or AIDS).Phase 1 trials often take nine to 18 months to complete.Many drugs are abandoned in Phase 1 testing because of problems with safety or toxicity.Phase 2 trialsSmall-scale, well-controlled trials evaluate the preliminary ________ AND ___________ in ____ to ____ patients with the disease or condition to be treated.May focus on dose-response, dosing schedule or other issues related to preliminary safety and efficacy.Often take one to three years to complete.Additional _________ testing may be conducted at the same time to obtain long-term safety data.If studies show drug to be safe and useful, testing may proceed to Phase 3.Phase 3 trialsThe most ____________ (and expensive) testing of a drug.These trials fully assess _________, efficacy and drug dosage in a _________ group of patients with the specific disease to be tested.Conducted on larger (______s to ________s) and more diverse groups of patients with the condition.Make comparisons between the new treatment and a placebo and/or the standard treatment.Trials help to better understand the drug’s safety and uncover any adverse effects.Trials often take two to five years to complete.New Drug Application (NDA)Submitted to the FDA once all or most of the proposed studies are completed.Submitted if company believes adequate positive information has been obtained to warrant a request to market the drug.The NDA contains extensive data on the investigational drug and results of the clinical trials.The NDA is many ______________ of pages long. The FDA hopes that eventually they will be submitted electronically.By law, the FDA has ___ days to decide if there is enough information to continue with the NDA review.By law, the FDA is required to make a final decision within 180 days.In practice this timeframe often is lengthened (considerably) by mutual agreement.New Drug Application (NDA) ReviewThe Center for Drug Evaluation and Research (CDER) reviews applications for pharmaceuticals.The Center for Biologics Evaluation and Research (CBER) reviews applications for biopharmaceuticals, ________, blood and _____________________.Phase 4 clinical trialsCompanies sometimes continue clinical trials of a drug after it has been approved for marketing. Phase 4 trials may be performed to learn more about side effects and long-term risks and panies also may evaluate different formulations of a drug (like _________________) or test the drug for a different indication.The FDA sometimes requires companies to conduct Phase 4 trials.Post-marketing surveillanceThe company must continue to report information about new findings and problems after drug approval._________________________ can report new findings to the company or directly to the FDA (consumers can report information to the FDA as well). A typical timetable from test tube to patientR&D and pre-clinical3.5 yearsPhase 11.0 yearsPhase 22.0 yearsPhase 33.0 yearsNDA evaluation2.5 yearsTotal 12.0 yearsProducing a Pharmaceutical or Biopharmaceutical-The Manufacturing ProcessProcess developmentScientists and engineers begin to figure out how to “_____________” production of a drug even __________ it receives FDA __________.Manufacturing processes might be quite different than the small-scale lab procedures.ProductionProduction of a pharmaceutical or biopharmaceutical involves many different, complex and lengthy steps:Synthesis (chemical or cell culture)PurificationFormulationFinal dosage form preparationStep 1: SynthesisOrder the raw materials needed to make the product.Test all raw materials to be sure they meet quality standards.For biomanufacturing, equipment and materials need to be ____________to avoid bacterial and other __________________ to the cell cultures. The product then is created.For pharmaceuticals, there are chemical processes involved (chemical synthesis).For biopharmaceuticals, cell culture or fermentation is involved.The product is referred to as the “_______________________”For the biopharmaceutical, the original cell culture is started in small bottles (around the size of large ________________)As the cells grow and multiply, they are introduced into a small __________________.Eventually they are grown in large bioreactors, which can be several ______________ tall!Step 1: BiosynthesisA small bioreactor in the foreground, with a larger one behind it.Step 2: PurificationAfter the active ingredient is synthesized, it must be purified.Purification involves removing the ___________ used in the process.For biopharmaceuticals, purification involves separating the ________ from the cellular nutrients and ______________ (the “soup”) they grew in. The end result of production is called the bulk product.The bulk product may be sold as is, processed further at the same plant or shipped to another plant for further processing.Step 3: FormulationSeveral other operations are required to get bulk product into its final form.Formulation involves chemical mixing operations to ________________________ ___________________________________, such as fillers, needed in the final form.The final form may be a solid (tablet or capsule), liquid, gels/creams or aerosols.Biopharmaceuticals usually are sold as sterile ___________ or sterile _____________.Step 4: Final dosage form preparationThe formulated preparation is made into its final form.The final form is ____________ into containers.The containers are ___________ and packaged.Quality mattersThe standards of quality are high because the stakes are high.Poor quality products can _________ or even _________ panies must conform to the stringent _________________________________ (GMP) regulations established by the FDA.Ensuring qualityManufacturers have three departments that ensure quality:Quality control (QC)Quality assurance (QA)ValidationQuality controlQC employees ____________ and ________ the raw materials and the product during many stages of the manufacturing process.Quality assuranceQA ensures product quality by setting up and checking the systems of ________________ __________________ (SOPs) and of documentation.SOPs guide every task by defining each _____________ in detail so it can be performed ____________ the same way every panies are required to prepare and follow SOPs by the FDA.Any _______________ from the SOP must be documented and approved by the QA department.Critical deviations that could affect product quality are investigated further.Documentation __________ that a company has done what it said.A company is required to have a traceable, written record of all processes and checks.“If it isn’t written __________, it doesn’t exist. If it isn’t written down, it never _____________.”ValidationValidation proves that a manufacturing process will ________________ produce the product to predefined specifications.The operation of every part of the plant that affects quality must be validated.If a manufacturing process is changed or if a new product is introduced, all processes and equipment that affect quality must be validated.Validation scientists and engineers have extensive experience because they must be very familiar with the regulations.Five rules for quality1. Understand _____________ needsCompanies have internal customers (fellow employees) as well as external customers.For a process technician, your internal customer is your coworker at the next stage of the process.2. Say what you do — write down proceduresStandard _____________ and ________ are required for every step.Batch records define the steps required to manufacture the product, the materials used, etc.3. Do what you say — ____________________Manufacturers are required to consistently and __________ follow procedures.SOPs are _________, and there are SOPs for every step.4. Prove it — keep recordsCompanies must have _____________, written records of all processes.Again, “If it isn’t written down, it doesn’t exist. If it isn’t written down, it never happened.”5. Improve itCompanies must continually evaluate its processes and procedures.They should take steps to make them ___________.Of course, new procedures must be validated!Standard Operating ProceduresSOPs define a __________________________ so it can be performed the same way, _______ __________.Lengthy regulations related to manufacturing are found in the Code of Federal Regulations.Good Manufacturing Practice (GMP) regulates methods, equipment, facilities and controls.What is included in SOPs?_____________ date- date the SOP takes effect.Purpose- describes purpose of _____________.Scope- states _______ the SOP applies to.Responsibility-states ________ should perform the SOP.______________- lists other SOPs or documents needed to perform the SOP.Materials and equipment- lists what’s needed to _____________ the SOP.Procedures- provides ________________ for carrying out a task.Approval signatures- shows the persons who have ___________ and ___________ the SOPWorkplace Realities- Getting a Job and Getting AheadWhat skills are needed to compete for jobs in biomanufacturing?1. The appropriate level of education and relevant job or military experience2. Mastery of basic skills3. Technical knowledge and skills4. Employee success skills1. Education and experienceAt least a high school diploma or GEDCompanies rarely hire workers directly out of high school; they prefer workers who have ______________ outside of the high school panies want employees with prior _____________ or _________________ panies value one to two years of college and an associate degree.Ways to obtain valuable experienceFieldwork or internship in the pharmaceutical industryUndergraduate research in a laboratoryEmployment in another type of manufacturing2. Mastery of basic skills Basic skills include:ReadingWritingCalculationProblem-solvingComputer literacy (general office software)Applying your reading, writing and math skillsReading ___________ reports from previous shiftsReading SOPs, equipment manualsWriting __________Using formulas to make solutionsApplying your computer literacy skillsUsing computers that control __________Writing reports using word processing software3. Technical knowledge and skillsApplying scientific principles and technical skillsGrowing _________Operating process equipmentAnalyzing production samplesInterpreting lab test resultsControlling the flow of _________ and liquidsPurifying productsIdentifying microbial _______________4. Nine employee success skillsA successful applicant demonstrates the ability to:A. manage ________.B. maintain a ________ and orderly work environment.C. keep learning new skills.D. follow procedures exactly.E. keep precise records.F. communicate effectively.G. work as a team member.H. solve problems, troubleshoot and _________ the process.I. understand and apply the principles of _________ business.A. Manage time______________ for work regularly and on timeIs willing and able to __________ to shift workManages personal schedule to meet shift schedulesPlans and organizes work and sets prioritiesCan attend to several tasks at onceCompletes tasks on time; keeps production on scheduleB. Maintain a safe and orderly work environmentComplies with health, environmental and safety regulationsFollows dress and protective clothing ________Assumes _______________ for safety of self and othersSets a ________________________ for othersHandles and maintains equipment and materials with careFollows good __________________ practicesC. Keep learning new skillsShows interest in learning new knowledge, skills and tasksIs _____________ and can work with _________ supervisionAccepts that ______________ learning is part of the jobD. Follow procedures exactly(_____________________)Follows directions exactly as written every timeTakes no shortcutsE. Keep precise records(___________________)Keeps records that are accurateKeeps records that contain required details“If it isn’t written down, it doesn’t exist.”“If it isn’t written down, it never happened.”F. Communicate effectivelyCommunicates _________ and shares information with others in a _________ mannerCommunicates effectively in ________, through ____________ (telephones, radios, e-mails) and in ___________.G. Work as a team memberRecognizes individual ______________ toward a goalAccepts _________________ for team’s success or failureAccepts own mistakes; is ________________ to corrections and suggestionsShares concepts, ideas and problems with others.Coordinates own work and the work of othersCan conduct meetings and help groups make decisionsIs eager to ________________________ othersH. Solve problems, troubleshoot and improve the processIs willing to learn the manufacturing process and how different units in the plant work togetherIs sensitive to anything unusual in surroundings (_________, _________, ________) and responds with appropriate action and communication to identify causes and solutionsSuggests ways to improve the manufacturing process, even when production is progressing without problemsKnows and can apply a variety of problem-solving approaches and methods to determine causes and recommend solutionsUnderstand and accept the principles of good businessUnderstands the need for ____________ in the manufacturing processCan identify factors within the manufacturing process that determine _________Can identify possible ___________ to profit in the manufacturing processCan explain why pleasing internal and external customers is critical to a company’s __________On the Job- Careers in BiomanufacturingSeizing the OpportunityBioprocess, pharmaceutical and chemical manufacturing jobs offer unique opportunities and benefits.You will be working in a ____________ industry.You will be working in an industry in which skilled and competent employees are in great demand.Advantages of working in this industry1. Pride in your productYou will have the satisfaction of making products that ___________ lives and boost the economy, including products that:increase ________ production, making it possible to feed the world.reduce _________ deaths and prevent childhood diseases.relieve painful symptoms, fight disease and save _________.2. Higher wagesEmployees in bioprocess, pharmaceutical and chemical manufacturing earn an average wage that is ____________ those in other manufacturing industries.Example: Entry-level process technicians earn $25,000 to $35,000 per year.3. Stable employment●A rapidly growing industry increases both the demand and opportunities for skilled, competent professionals.●Your knowledge is your ___________________ insurance. ●Your mastery of process manufacturing technology is portable. ●If the particular company you work for downsizes, you are very likely to find a job in a different company.4. Modern and professional atmosphere ● High-tech, computer-controlled, efficient environments staffed by well-educated, professional technicians, engineers and scientists. ● Many companies use a __________ approach and encourage employees to assume higher levels of responsibility for problem solving.5. Safe working environments ●Because they are highly regulated by the government and required to follow very detailed good manufacturing practice (GMP), biotechnology, pharmaceutical and chemical companies provide a very _________ place to work. ●One of the first things you will acquire on the job is thorough training in __________.6. Job variety and career advancement Employees often have an opportunity for ________ training or moving from one department to another. As employees gain more experience, there also are opportunities for career advancement. Employees can advance in managerial tracks, with more _______________ responsibility.Employees may choose to advance within scientific or engineering specialty tracks. Biotechnology, pharmaceutical and chemical companies often have programs that ________ employees for their knowledge and skills.They reward employees for completing in-house training and formal academic education. Many companies provide some ________ support for employees to attend college courses.On the Job-Educational optionsMany educational options are available: Two-year (associate or A.A.S.) degreesFour-year (bachelor or B.S./B.A.) degreesCertificate programsEven for jobs requiring only a high school degree, companies _________ hire anyone straight out of high school. Employers look for at least some additional __________________, prior employment or military experience that Entry-level positions are availableThe good news — there are many different entry-level positions in biomanufacturing. Entry-level jobs are ones that require a particular level of education but no ________ work experience in the pharmaceutical or biopharmaceutical industries. Job titles and descriptionsThe job titles and brief descriptions listed on these slides illustrate the type of positions that exist in a generic biomanufacturing facility. The actual organization of the various divisions, job titles and job descriptions vary from one company to another. The job descriptions are grouped into five areas: 1. Production2. Quality control (QC), quality assurance (QA) and validation3. Manufacturing Support4. Research and development (R&D)5. Other divisions1. Production PositionsTechniciansPositions include various technicians who work “___________” in the biomanufacturing facility.These entry-level positions require a high school diploma, a process technician certificate or an A.A.S. degree, plus some “maturation time” after high school. Production: _____________________Responsible for a variety of tasks involved in monitoring and control of manufacturing the product.Production: Manufacturing prep process technicianResponsible for washing, drying and sterilizing ______________.Production: Formulation/fill technician Responsible for preparing the finished product from the purified active pharmaceutical or biopharmaceutical ingredients.Production: Packaging technician Uses packaging systems to label, ___________ and package the finished product.Production: Process engineers These are entry-level positions requiring a four-year engineering degree — a bachelor of science (B.S.) in engineering.Production: Process engineer in manufacturing ●___________, develops and operates the current manufacturing process.● Works with technicians to ensure that the product is manufactured properly.Production: Process engineer in process developmentResponsible for the design, ____________ and validation of new processes, from the laboratory, to pilot-plant stage, to large-scale manufacturing. 2. Quality control positionsQuality control (QC) involves checking the ____ ______________ and ___________ during every phase of its manufacture.QC jobs include:entry-level positions requiring an A.A.S.entry-level positions requiring a B.A./B.S.positions requiring B.A./B.S. plus industry experience.QC: Quality control assistantAnalyzes raw materials, in-process samples and finished formulations according to SOPsEntry level; requires a two-year degree (A.A.S.). QC: Quality control associate● Coordinates activities needed to ____________ good manufacturing practice (GMP) and to update _______’s. ● Reviews data obtained by the QC assistant and reports abnormalities.QC: Quality control engineer_________, revises and maintains ___________ for converting raw materials into products.Devises SOPs for testing procedures.QC: Process quality inspectorPerforms a wide variety of inspections, checks, tests and sampling procedures related to the manufacturing process.2. Quality assurance positionsQuality assurance (QA) focuses on the _______ system of manufacturing.QA employees set up and check the standard operating procedures (SOPs) and documentation.Their jobs ensure product quality and compliance with Good Manufacturing Practice (GMP) regulations.These positions require a B.A./B.S.QA: Quality assurance associateWrites and edits SOPs, laboratory procedures, manuals and other documents in a ________________.QA: Quality assurance auditorPerforms audits of production and quality control to ensure compliance to in-house specification, standards and regulatory requirements.2. Validation positionsValidation proves that an SOP will ___________ produce the product with certain specifications when carried out exactly.The operation of every part of the plant has to be validated. Generally all validation positions require work experience in the industry. 2. Validation positions● Validation specialist (minimum A.A.S./B.S. degree)● Validation engineer (minimum B.S. in engineering)● Validation scientist (minimum B.S. in science)Validation specialist, engineer and scientistResponsible for ensuring a product is manufactured in accordance with regulations and in-house standards. Validation engineers and scientists often have advanced degrees (M.S. or Ph.D.) and generally need extensive experience in the industry. They must be thoroughly familiar with the ____ regulations and how to implement them.3. Manufacturing supportMaintenance of the plant and all of its ___________ (electrical systems, water purification systems and heating, ventilation and air conditioning)Management of _________ products created during the manufacturing processMany of these jobs are entry-level positions.Manufacturing support: _______________/calibration ______________Responsible for calibrating, testing, troubleshooting, repairing and maintaining a variety of circuits, components, analytical equipment and instrumentation.Manufacturing support techniciansManufacturing support technicianMaintains manufacturing equipment and solves production problems caused by machinery.Environmental technicianPerforms routine _______________ testing and carries out waste treatment operations.Manufacturing support engineers Maintenance engineer Involved with ________________ and repairs of refrigeration, air conditioning, steam boilers, etc.____________________________Designs and installs instruments to monitor and control certain manufacturing processes.Environmental engineer Designs waste storage, treatment and recycling facilities.4. Research and development (R&D) These scientists generally work in labs that are _____ _________ of the manufacturing facility.The educational requirements for these positions vary considerably.Although many companies have entry-level positions, they greatly value experience in the industry.R&D: Research assistant and associateResearch assistant Performs lab ___________________ and tests according to good laboratory practices under the direction of a research associate.Research associate Seeks out new and more efficient ways to use and produce existing products.R&D: Research scientists in drug discoveryWork in a team in numerous areasIdentifying new drug ___________Creating animal models to test new drugsInvestigating the causes of and treatments for ____________.Disciplines include: chemistrycell biologymolecular biologybiochemistry 5. Other divisions ● These employees may work in offices within the facility or at another location.● The educational requirements vary according to the job.● Companies value experience in the industry and often require it.Other divisions: Customer support specialistResponsible for ensuring _________ of product that meets the customers’ requirements.May serve as a ___________ for customers with technical questions. Requires a four-year degree and usually some industry experience.May work in offices within the facility or in another location. Other divisions: Clinical trials associate (CRA)Assists in the monitoring and management of clinical trials.Position requires knowledge of _________ __________________, clinical research, federal regulations and good clinical practices.Experience in the industry is highly desirable.Other divisions: Regulatory affairs specialist Coordinates and prepares a variety of documents to submit to the _____.There is considerable opportunity for _______________, within the regulatory affairs department as well as moves into other departments.The regulatory affairs associate usually is the entry-level position (although industry experience may be required). ................
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