This article reveals a few key considerations for those setting up a biopharma lab, including important equipment and compliance obligations.
Setting up a biopharma lab typically requires large capital expenditures, so it’s vital that decision-makers carefully consider purchases necessary for key lab functions. The biopharma industry is also one of the most heavily regulated, so it’s also crucial to bear in mind compliance requirements.
Key equipment required for a biopharma lab
Biopharma labs are facilities where biological medical products are developed. Biopharmaceuticals are extracted from, manufactured in, or semi-synthesized from living cells or organisms and are used to treat a wide range of medical conditions. Examples include certain vaccines, blood or blood components, stem cells, tissues, and gene therapies.
These products can be difficult and expensive to produce, store, and transport, particularly because they are often heat-sensitive and easy to contaminate. Biopharmaceuticals are often produced by leveraging cutting-edge methods, and thus, labs may require state-of-the-art equipment and technology.
The list below covers some of the equipment most commonly found in a biopharma lab.
Labs use bioreactors to cultivate cells. A bioreactor can take various forms but is often a stainless steel tank fitted with an agitation system and features such as a thermal jacket, feeding pump, aerator, and sensor probes. These vessels provide an optimal environment for cell growth, helping to produce large quantities of cells in a short period of time. They can also be used to cultivate cells under specific conditions, such as those that mimic the human body.
Bioprocess containers help to create an optimal environment for cell growth and come in many shapes and sizes. The most common type is the culture dish, which is used to grow cells in a controlled environment. Other types of bioprocessing containers include flasks, bottles, and tubes and can be made of glass, plastic, or metal.
Centrifuges are used to separate cells and other particulates from suspensions. By spinning at high speeds, centrifuges force heavy particles to the bottom of a tube while lighter particles remain suspended in the liquid. This allows for the easy separation of cells from culture media or other liquids. There are a variety of centrifuges available. For example, benchtop centrifuges are small and compact, making them ideal for use in cramped lab spaces, but they have a lower capacity than floor-standing centrifuges and may not be suitable for large-scale experiments.
Incubators allow for the precise control of temperature, humidity, and other factors that can affect cell growth, playing a vital role in ensuring the accuracy and reproducibility of results. They can be equipped with special features such as CO2 sensors and oxygen level monitors.
Chromatography is a common technique used in biopharma labs to purify and separate biomolecules. There are many types of chromatography, including:
- Ion exchange chromatography: Based on a protein’s net charge
- Size exclusion chromatography: Molecules are separated by size or molecular weight
- Hydrophobic interaction chromatography: Based on hydrophobicity
- Reverse phase liquid chromatography: HPLC using a nonpolar stationary phase and polar mobile phase
Biosafety cabinets minimize the risk of exposure to hazardous substances. There are several types of biosafety cabinets. Class I cabinets are designed to protect users and the surrounding environment, but not samples, and are often used for procedures that may generate aerosols. Class II cabinets provide protection for users, the environment, and samples, and are the most common type of cabinet used in a biopharma lab. Class I and II cabinets are suitable for use with low to moderate risk biological agents, including some pathogenic or infectious organisms, as well as certain indigenous or exotic agents. Class III cabinets, also called glove boxes, are used with high-risk microorganisms. These enclosures are gas-tight and all materials must enter only through a double-door autoclave or dunk tank.
Sterilizers are used to disinfect lab equipment, as well as sterilize media and other solutions. The most common type of sterilizer is the autoclave, which uses steam to kill microbes. Another is the dry heat oven, which uses hot air to kill microbes.
When choosing a freezer, it’s important to consider the type of unit (for example, upright, under-counter, or chest), the temperature range (some ultra-low freezers can maintain temperatures as low as -80°C), size, capacity, and energy efficiency. You may also want to consider additional features such as alarm systems that indicate when the temperature has fluctuated above or below a setpoint.
Biopharma lab compliance and regulation considerations
Products manufactured in biopharma labs must meet strict regulatory standards to ensure the safety, quality, and efficacy of drugs. The following list outlines some of the key standards and organizations to consult when setting up a biopharma lab. Note that applicable standards will differ depending on the country in which a lab is located and where products will be used.
The Food and Drug Administration (FDA) regulates both pharma and biopharma products in the United States. The organization’s mandate is to assure the quality, safety, and efficacy of drugs and biological products.
The most important FDA regulations for biopharma labs to consider are GxPs. GxP regulations cover multiple sets of practices, with emphasis on three in particular: good laboratory practices (GLP), good clinical practices (GCP), and good manufacturing practices (GMP). These global regulations and guidelines apply to all life science products to ensure their safety. They focus on traceability, accountability, and data integrity.
There are also other, more detailed FDA regulations that apply to biopharma labs including Analytical Procedures and Methods Validation, Bioanalytical Method Validation, Microbiological Pharmaceutical Quality Control Labs, and Biotechnology Inspection Guide. Documents required for approval may include the Investigational New Drug Application (IND), New Drug Application (NDA), and Biologic License Application (BLA).
The Clinical Laboratory Improvement Amendments (CLIA) are a set of regulations governing all clinical laboratories in the United States.
The main purpose of the CLIA program is to ensure the accuracy and precision of lab testing. CLIA covers everything from quality control procedures to personnel qualifications, and it includes requirements for each type of lab test. In order to comply with CLIA, biopharma labs must have appropriate policies and procedures to ensure the quality of their testing, and they must train their staff in the use of CLIA-compliant methods.
The European Medicines Agency (EMA) is responsible for the scientific evaluation of medicines developed by biopharma companies in Europe. A key guide for European biopharma labs is The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practices Medicinal Products for Human and Veterinary Use.
The International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a worldwide initiative that brings together regulatory authorities and pharmaceutical industry experts from the United States, Europe, and Japan. The objective of the ICH is to improve the quality, safety, and efficacy of medicines by harmonizing the guidelines and technical requirements for their registration across regions. The ICH publishes guidelines that are signed into law in its member countries or recommended by national authorities within those countries.
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