Biotech Industry Notes

Biotech Industry

Standard Corporate Structure

• Biotechnology companies employ individuals from various disciplines.
• Positions include:
  • Scientists and technicians in laboratories.
  • Production staff.
  • Quality control personnel.
  • Marketing teams.
  • Agricultural, medical, and environmental experts (depending on the company).

Research and Development

• Research scientists and technicians collaborate to:
  • Create new products and processes.
  • Improve existing products and processes.
• This phase emphasizes creative problem-solving.
• Departments:
  • Research: Focuses on discovering new products and processes.
  • Development: Transitions discoveries to the production phase.

Production Department

• Responsible for manufacturing products developed in R&D.
• The department's setup varies based on the product:
  • May resemble a large-scale laboratory.
  • May resemble a cleanroom with machinery.
• Job titles include:
  • Manufacturing Operator.
  • Technician or Supervisor.
  • Production Technician.
  • Pilot Plant Operator or Technician.

The Quality Department

• Establishes guidelines to monitor manufacturing processes.
• Examines in-process and finished products to ensure they meet quality standards.
• Tasks are divided between Quality Assurance (QA) and Quality Control (QC).

Quality Control (QC)

• Responsible for testing and sampling.
• Ensures compliance with specifications set by Quality Assurance.
• Technicians sample and test at various stages, including equipment and facilities.
• Follows directions from Quality Assurance; limited decision-making role.

Quality Assurance (QA)

• Sets up systems and methods to assure product quality.
• Accountable for all factors influencing quality.

Quality Assurance (QA) vs. Quality Control (QC)

Quality Assurance (QA)

• Proactive approach
• Broad process
• Goal: Prevent quality failures.
• Takes place throughout the development process.

Quality Control (QC)

• Reactive approach
• Narrow process
• Goal: Detect mistakes or errors in a product.
• Takes place after development.

Careers in Biotechnology

• Biotechnology is a rapidly growing field with many career opportunities.
• Examples include:
  • Food, plant, and animal research and development.
  • Production of medical equipment and research materials.
  • Pharmaceutical research, production, and sales.
  • Pharmacy technician specialist.
  • DNA testing.
  • Cancer research, including testing device development.
  • Production of dietary supplements.
  • Military and Homeland Security.
  • Laboratory assistant, coordinator, or manager.
  • Manager of regulatory affairs.

Growth in the Field of Biotechnology

• Growth has exceeded expectations.
• As of 2023, 431,633 people are employed in biotechnology.
• A 5% growth is expected in biotechnology technicians between 2023 and 2032.
• The field is expected to continue growing.

Training for Careers in Biotechnology

• Degrees in Biotechnology, Biology, Biochemistry, Environmental Engineering, or Engineering can prepare you for a biotechnology career.
• Essential practical skills:
  • Research design and data analysis.
  • Critical thinking, problem-solving, and troubleshooting.
  • Business strategy and entrepreneurship.
  • Scientific project management.
  • Legal and regulatory affairs.
  • Written and verbal technical communication.
  • Leadership and teamwork.
  • Professional and ethical behavior.

Careers in Biotechnology (Continued)

• Biotechnology extends beyond many disciplines.
• Expected to be one of the most important applied sciences in the 21st century.
• Applications in:
  • Human health.
  • Agriculture and food.
  • Biofuels.
  • Environmental protection.
  • Forensics and security.
  • Industrial products.
  • Instrumentation and suppliers.
  • Scientific research.

Academia and Government Careers

• Similarities between academia and government sectors:
  • Focus on "pure science" research (knowledge and facts).
  • Nonprofit labs.
  • Funding from grants (industry, foundations, or government).
  • Data sharing through scientific publications.

Academia Careers

• Responsibilities:
  • Formulating hypotheses.
  • Writing grants for research funding.
  • Conducting research.
  • Submitting work for peer review.
  • Publishing in journals.
  • Educating college students.
• Offer more research freedom, which can make the work feel meaningful.

Government Careers

• Research is funded by taxpayers.
• Research may be dictated by public interest.
• May be seen as obscure until a breakthrough is made, leading to potential public scrutiny.
• Investments typically aim to advance knowledge or solve significant problems (e.g., alternative energy).
• Requires justifying research to the public.
• Examples:
  • CDC (Centers for Disease Control and Prevention)
  • NIH (National Institutes of Health)

Private Sector Careers

• Funding comes from companies instead of grants.
• Research projects are provided by the company.
• Involves brainstorming to create the final product.
• Research is focused on the company’s thematic areas.
• Highest paid area in biotechnology.
• Employees include:
  • Scientific staff.
  • Nonscientific staff (administrators, clerical workers, sales and marketing representatives).

Private Sector (Continued)

• Goal: Produce and sell products for profit.
• Aims to retain valuable employees and invest in research and development.
• Four main categories of companies based on products:
  • Pharmaceutical products.
  • Agricultural products.
  • Industrial products.
  • Research or production of instruments, reagents, or data.
• Some companies sell services (e.g., genome sequencing).

Steps to Create a Bioengineered Product

1. Identify a gene that gives a desired trait.
2. Copy the information from the organism with the trait.
3. Insert the information into the DNA of another organism.
4. Grow the new organism.

Small-Scale Production

• Manufacturing bioengineered products on a smaller scale.
• Aims:
  • Establish and optimize the production process.
  • Early-stage development and optimization.
  • Feasibility studies.
  • Proof-of-concept studies.
  • Preclinical volume production and testing.
  • Manufacturing for clinical trials.
• Produces a limited amount of product.

Medium and Large-Scale Production

• Medium-scale production:
  • Lower cost than small-scale production.
  • Higher cost than large-scale production.
• Large-scale production:
  • Lowest cost.
  • Occurs when the product is ready for market.
  • Quality of production is consistently successful.

Development of a New Biotech Product

Step 1: Research and Development (R&D)

• A biotechnology company's goal is to market a product quickly.
• R&D can take several years.
• A drug needs to demonstrate "proof of concept" in the lab.
• Questions to answer:
  • Is it feasible to produce the medicine in sufficient amounts?
  • What needs to be done to ensure safety?
  • Which characteristics indicate efficacy?
  • Is it stable over time?
  • Will its properties change with a different process?

Step 2: Pre-Clinical Trials

• Purpose is to determine toxicity.
• Types:
  • In-Vitro: Uses human or non-human derived cells.
    • Limited because it does not test the whole animal.
    • Beneficial because it is cheap and does not harm animals.
  • In-Vivo: Uses non-human animals.
    • Better visualizes potential interactions.
    • Ethical concerns of using animals.

Step 3: Clinical Trials

• Conducted under the FDA.
• Three phases with progressively more human subjects.
• Takes 10-15 years for a pharmaceutical product to move through the "product pipeline" (R&D → production).
• Companies have a limited number of products in the pipeline at a time.
  • Larger companies: 10-15 products.
  • Smaller companies: 2-3 products.

Formulation, Packaging, & Warehousing

• Formulation: Combining the drug with inactive ingredients to ensure consistent quality.

  • Dosage should have a uniform appearance and rate of disintegration.

• Packaging: Selecting proper packaging to ensure quality up to the point of use.

  • Must be airtight and sterile.
  • Must consider external factors (humidity, temperature, and light).

• Warehousing: Storage must be temperature-controlled.

  • Shipping must be considered due to temperature changes that can denature bioengineered pharmaceuticals.
  • Temperature guidelines:
    • Ambient Temperatures: 20-25^[\circ]C
    • Refrigerated: 2-8^[\circ]C

Safety and Legal Compliance

• All biotechnology products have regulations.
• Agencies:
  • Environmental Protection Agency (EPA): Enforces environmental laws related to microorganisms, herbicides, pesticides, and genetically modified organisms.
  • Food and Drug Administration (FDA): Regulates food, feed, food additives, veterinary drugs, human drugs, and medical devices.
  • US Department of Agriculture (USDA): Regulates plants, plant products, plant pests, veterinary supplies and medications, and genetically modified plants and animals.

Code of Federal Regulations

• Details quality management, organization, device design, buildings, equipment, etc.
• Divided into 50 titles.
• Title 21 includes:
  • Parts 1-99: Product jurisdictions, protection of human subjects, institutional review boards.
  • Parts 100-799: Food, human and animal drugs, biologics, cosmetics.
  • Parts 800-1200: Medical devices and radiation-emitting products.
  • Parts 1300-1499: Controlled substances.

Corrective and Preventative Action

• Purpose: Collect and analyze information, identify and investigate problems, and take corrective and/or preventative action.
• Basic Guidelines:
  1. Create and submit a request.
  2. Review the request (by a quality manager or Quality Review Board).
  3. Finalize sources and build your team.
  4. Identify immediate corrective actions.
  5. Investigate and record findings.
  6. Determine the root cause.
  7. Develop, execute, and implement your action plan.

Current Good Practices (cGxP)

• Set and monitored by the FDA and other regulators.
• The "x" is interchangeable for science disciplines:
  • Current Good Manufacturing Practices = cGMP
  • Current Good Laboratory Practices = cGLP
  • Current Good Clinical Practices = cGCP
  • Current Good Distribution Practices = cGDP
• Purpose: Ensure a product is safe and meets its intended use.
• Important parts:
  • Traceability: Procedures can reproduce the exact same product.
  • Accountability: Documentation of people involved and their contributions.

Lifecycle Requirements

• Lifecycle stages encompassing concept, planning, specification, implementation, verification, operation, change, project, operation, and retirement.

Maintaining Validated State

• This is done through design review, risk management, change control and traceability through the different stages.

Quality Management System

• A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Goal: Meet customer and regulatory requirements and improve an organization’s effectiveness and efficiency.

Requirements for a QMS

• The organization’s quality policy and quality objective.
• Quality manual.
• Procedures, instructions, and records.
• Data management.
• Internal processes.
• Customer satisfaction from product quality.
• Improvement opportunities.
• Quality analysis.

Four Components of a QMS

1. Quality Control Planning: Identify goals, quality standards, and necessary requirements.
2. Quality Control: Inspecting and testing that standards are met; correcting errors.
3. Quality Assurance: Reviewing service delivery or quality management of manufacturing.
4. Quality Improvement: Reviewing findings and improving methods.Ensure traceability.Reproducibility.Accountability.Documents the people involved and how they contributed. Current Good Distribution Practices = cGDP.
   Ensure reproducibility
   Ensure traceability