Book:The Laboratories of Our Lives: Labs, Labs Everywhere!/Labs by industry: Part 4/Pharmaceutical

From LIMSWiki
Jump to navigationJump to search
-----Return to the beginning of this guide-----

6.3 Pharmaceutical

Generic Propecia.jpg

The pharmaceutical laboratory is complex, but at its core the laboratorians in them aim to better develop, analyze, improve, and quality control the drugs and medical devices that improve humans' and animals' quality of life. Due to the potential health risks of ingesting/implanting a poorly tested pharmaceutical/medical device, these labs tend to be heavily regulated by governments. In fact, the governments themselves will often have their own labs to test for product quality and lab compliance. Universities provide not only education programs and graduate research opportunities but also pharmaceutical analysis and outreach programs. Pharmaceutical labs are found in the private, government, and academic sectors, providing many different services, including (but not limited to)[1][2][3]:

  • hit picking/screening of potential therapeutics
  • method development and validation
  • stability and photostability testing
  • shelf life testing
  • bioequivalence testing
  • dissolution testing
  • impurities testing
  • counterfeit testing
  • formulation optimization
  • quality control

But how do pharmaceutical laboratories intersect the average person's life on a daily basis?

In a 2000 journal article published in Journal of Automated Methods & Management in Chemistry, author Juanita M. Hawkins of Jansen Pharmaceutica noted the following: "Understanding the contributions that the laboratory can make in product/process development, process improvement, market surveillance and general business is key to the pharmaceutical business today. Poor laboratory practice yields compliance issues, increased cost, increased cycle time and delayed product introductions."[4] While a very business-centered statement, reading between the lines—and further into the journal article—reveals why properly run pharmaceutical labs are important to the average person today: "customers expect the product to be safe and efficacious" and "that it meets all specifications."[4] All but those participating in a primitive society will at one point (if not frequently) have the need to be treated with a pharmaceutical drug or device. Without the associated laboratories and quality control (QC) procedures in place, the pharmaceuticals would be of poor quality (if they existed at all) and endanger many lives. Even if you take something as simple as an aspirin, remember that a lab developed it, improved it, and/or QCed it for your benefit.

6.3.1 Client types

Private - These labs are either part of a pharmaceutical company's portfolio or are third-party contract labs that provide extensive analysis and consulting services.

Examples include:

Government - Government pharmaceutical labs typically act as either research centers or in an official regulatory capacity to ensure product quality and lab compliance.

Examples include:

Academic - The pharmaceutical engineering labs in the academic sector provide not only education programs for students and graduate research opportunities but also pharmaceutical analysis and outreach programs.

Examples include:

6.3.2 Functions

What are the most common functions? analytical, QA/QC, research/design, and teaching

What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled? biological agents and samples, contaminates, drug substances, elemental metals, microbials, proteins, raw materials, solvents

What sciences are being applied in these labs? biochemistry, biology, chemistry, genetics, molecular biology, neuroscience, pathology, pharmacology, physiology, posology, toxicology

What are some examples of test types and equipment?

Common test types include:

Absorption, Active ingredient, Acute contact, Acute oral, Acute toxicity, Alcohol level, Allergy, Altitude, Amino acid analysis, Angle of repose, Antimicrobial, Bioavailability, Bioburden, Biocompatibility, Bioequivalence, Biosafety, Boiling - freezing - melting point, C- and N-terminal, Carcinogenicity, Characterization, Chronic toxicity, Circular dichroism, Cleanliness, Clinical diagnostic, Colorimetric, Compendial, Compliance/Conformance, Composition, Congealing point, Contamination, Cytotoxicity, De novo protein, Detection, Developmental and reproductive toxicology, Disintegration, Dissolution, Disulfide bridge, Efficacy, Electrophoresis, Endotoxin, Expiration dating, Extractables and leachables, Flavor, Formulation, Fragrance, Friability, Functional observational battery, Genotoxicity, Human factors, Identification, Impurity, Ingredient, Ingress, Inhalation, Irritation, Iterative, Locomotor activity, Lot release, Microfluidics, Minimum bactericidal concentration, Minimum inhibitory concentration, Moisture, Molecular weight, Mutagenicity, Nanoparticulate, Organic carbon, Osmolality, Osmolarity, Oxidation reduction potential, Oxidation stability, Pathogen, Peptide mapping, Permeability, pH, Pharmacokinetic, Photostability, Phototoxicity, Polarimetry, Post-translational modification, Preservative challenge, Process safety, Proficiency, Protein analysis, Protein characterization, Purity, Pyrogenicity, Quality control, Radioactivity, Radiochemical, Safety, Saponification value, Sensitization, Solubility, Specific rotation, Stability, Sterility, Subchronic toxicity, Surface tension, Thermal, Total viable count, Toxicokinetic, Ultraviolet, Usability, Validation, Verification, Virucidal efficacy, Water activity

Industry-related lab equipment may include:

animal monitoring equipment, balance, biological safety cabinet, blood and hematology analyzers, calorimeter, cell counter, cell disruptor, cell harvesting system, centrifuge, chemical synthesizer, chromatographic, cryocooler, dissolution equipment, dissolved oxygen meter, DNA shearing sonicator, drying and heating chamber, electrophoresis equipment, flow cytometer, flow injection analyzer, freeze dryer, freezer, fume hood, glove box, hit-picking system, incubator, inhalation chamber, interferometer, laminar flow cabinet, liquid handling equipment, metallic iron analyzer, microplate equipment, particle counter, PCR equipment, pH meter, powder analyzer, pumps and sprayers, refractometer, rheometer, solid phase extraction equipment, spectrometer, spectrophotometer, steam sterilizer, sonicator, turbidity meter, UV chamber, vacuum evaporator, viscometer, water purification system

What else, if anything, is unique about the labs in the pharmaceutical industry?

QC is important to any laboratory; however, in the pharmaceutical industry, many countries like the U.S. place extra emphasis on pharmaceutical QC labs. "The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control ... This includes pharmaceutical laboratories used for in-process and finished product testing," says the U.S. Food and Drug Administration.[5] Even the World Health Organization puts focus on their importance, pointing out[6]:

The government, normally through the national medicines regulatory authority (NMRA), may establish and maintain a pharmaceutical quality control laboratory to carry out the required tests and assays to verify that APIs, excipients and pharmaceutical products meet the prescribed specifications. Large countries may require several pharmaceutical quality control laboratories which conform to national legislation, and appropriate arrangements should, therefore, be in place to monitor their compliance with a quality management system.

As Maura May notes for Pharmaceutical Manufacturing, the importance of these labs not only lies in protecting the public and company; they're a product of a competitive environment, where spending, cleanliness, and lead times are vital.[7]

6.3.3 Informatics in the pharmaceutical industry

In the pharmaceutical industry, we can look at how informatics is applied in two key ways:

  • the drug discovery and R&D phase, found within the pharmaceutical company continuum (sometimes referred to as drug discovery informatics, and pharmacoinformatics)
  • the dispersal and use phase, found within the healthcare continuum (sometimes referred to as drug informatics, pharmacy informatics, and pharmacoinformatics)

In the first case, drug discovery and development is supported using data analysis and management tools that allow laboratory researchers to model molecules, search and visualize research data, build databases, and track efficacy.[8] In the other, patients and doctors are provided with more relevant and timely drug information, drug utilization reviews, medication-related policies and procedures, and dispensing practices.[9] The development and propagation of informatics tools to perform these and other important tasks in and out of the lab are furthered by journals such as ASSAY and Drug Development Technologies[10] and special interest groups like the Association of Faculties of Pharmacy of Canada (AFPC)'s Pharmacy Informatics SIG.[11]

6.3.4 LIMSwiki resources and further reading

LIMSwiki resources

Further reading


  1. Wu, G. (2010). "13.6 HTS Operation Management". Assay Development: Fundamentals and Practices. John Wiley & Sons. pp. 347–354. ISBN 9780470583111. 
  2. "Element in Pharmaceutical Testing". Element Materials Technology. Retrieved 29 June 2022. 
  3. Hansen, S.; Pedersen-Bjergaard, S.; Rasmussen, K. (2012). Introduction to Pharmaceutical Chemical Analysis. John Wiley & Sons. pp. 624. ISBN 9781119954330. 
  4. 4.0 4.1 Hawkins, J.M. (2000). "The Importance of the Laboratory to the Pharmaceutical Business". Journal of Automated Methods & management in Chemistry 22 (2): 47–52. doi:10.1155/S1463924600000067. PMC PMC2548258. PMID 18924858. 
  5. "Guide to Inspections of Pharmaceutical Quality Control Laboratories". U.S. Food and Drug Administration. 13 November 2014. Retrieved 30 June 2022. 
  6. "WHO Good Practices for Pharmaceutical Quality Control Laboratories". World Health Organization. 2010. pp. 49. Retrieved 30 June 2022. 
  7. May, M. (16 September 2014). "Leaning the Quality Control Laboratory". Pharmaceutical Manufacturing. Putman Media. Retrieved 30 June 2022. 
  8. Kumar, S.; Plotnikov, N.V.; Rouse, J.C.; Singh, S.K. (2017). "Biopharmaceutical Informatics: Supporting biologic drug development via molecular modelling and informatics". Journal of Pharmacy and Pharmacology. doi:10.1111/jphp.12700. PMID 28155992. 
  9. Woldu, M.A.; Lenjissa, J.L. (2014). "Drug Informatics from Evolution to the Present Outlook". Journal of Health and Medical Informatics 5: 161. doi:10.4172/2157-7420.1000161. 
  10. "ASSAY and Drug Development Technologies". Mary Ann Liebert, Inc. Retrieved 30 June 2022. 
  11. "Pharmacy Informatics SIG". Association of Faculties of Pharmacy of Canada. Retrieved 30 June 2022.