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A biopharmaceutical is a drug in which the active substance is manufactured or extracted from biological origin materials. They are usually produced in bioreactors by plant cells, microbial cells, yeast cultures, or mammalian cells. They are used to either treat or diagnose and prevent a patient’s medical condition or disease. Biopharmaceuticals are typically complex macromolecules administered by injection or infusions, and examples include vaccines, serums, and insulin.

What biopharmaceuticals equipment do you need?

Online sampling system for larger scale bioprocesses

Accurate sampling is vital for improving a wide variety of industria...

Online fraction collector for offline bioprocess analysis

Many bioprocesses require offline analysis of samples to monit...

Sampling probe for bioreactor samples

In biopharmaceutical and chemical industries, sampling is vital to develop, maintain,...

Sampling probe suitable for fermenter samples

Accurate, sterile sample collection is vital across a range of biopharmaceut...

Fluid sample-taking module for high cell density cultures

Automatic sampling of reactor vessels requires careful fluid m...

Accessory feed pump for various applications

In many biopharmaceutical or chemical development processes, lab work can be ...

Fluid sensor technology for flow rate measurement

For many bioprocesses, precise measurement of media flow rates is vital...

Automatic sampling system for bioprocess monitoring

An accurate, automated sampling of cultures is a key requirement in t...

Entry-level automated online sampling system

An accurate and sterile sampling of cultures is vital throughout the biopharm...

Rotary vial washing machine

When washing vial, ampoules, or cartridges for pharmaceutical production there is often a trade-...

Industrial vial capping machine

The high capacity production of pharmaceuticals delivered in vials and cartridges requires a...

External vial washing machine

Exterior washing solutions for vials often suffer from high water consumption and low throughp...

Aseptic vial cap sealing machine

Aseptic production methods are at the heart of the latest development in pharmaceuticals in...

Vial sterilization tunnel

Sterilization of vials, ampoules and syringes before filling is a vital step in the production of ...

Vial filling machine

The volume filling of vials, cartridges and syringes is a vital part of the production of a wide range o...

Aseptic automatic vial filling machine

Current and future developments in pharmaceuticals increasingly rely on aseptic prod...

Aseptic automatic vial washing machine

The production of the latest high value pharmaceuticals often requires aseptic handl...

Automatic vial tray loader

In modern pharmaceutical production, end-line processes are often still manual or slow. This can ...

Syringe tub sterilizer

A common challenge is how to transfer nested syringe tubs to the aseptic filling area without compromi...

Nested syringe filling machine

Increasingly, pre-sterilized Ready To Use (RTU) nested vials, cartridges and syringes are the...

Closed restricted access barrier system

Pharmaceutical production techniques often require isolation of compounds and chemi...

Compounding aseptic isolator

Bespoke aseptic isolators designed for production environments don’t meet the needs of small-sc...

Sterile compounding system

Hospitals and compounding centres have traditionally used manual aseptic compounding processes. A...

Distributor of samples to different devices

The ability to expand your automatic sampling solution provides increased flex...

GMP laboratory freeze dryer

Freeze dryer designed for aseptic and small-scale production of high-value products.

Transfer system for high-containment environments

A high-performance transfer port system that combines ultimate safety, ...

Purified water systems

Highly Purified water is used in the preparation of medicinal products where bacterial endotoxins need...

Half-suit tester

Designed to allow operators to perform sterility testing in an aseptic environment providing assurance of mat...

Glove tester

Testing device of the containment capability of gloves, which is as important as the other parts of the integrate...

Multipurpose and R&D freeze dryer

A multipurpose unit in the research and development field. Some of the most common ap...

Negative pressure isolator

Used for products biologically hazardous, that also require minimized cross contamination.

Downflow booth

Provides the highest levels of operator protection from potentially harmful airborne contaminants generated dur...

Vertical laminar flow cabinet

HEPA filtered vertical laminar airflow (down flow) creates an ISO 14644-1 (Class 5) work area ...

Horizontal laminar flow benches

HEPA filtered horizontal laminar airflow (crossflow) creates an ISO 14644-1 (Class 5) work a...

Compact horizontal laminar flow bench

HEPA filtered horizontal laminar airflow (cross-flow) creates an optimized free space...

Microbiological safety cabinet class II

This handy device offers the most advanced features in product-operator protection ...

Biosafety cabinet class II for cytotoxic medicines

For the manipulation of hazardous substances utilized during the prepa...

Positive pressure isolator

Ideal for products which have no biological risk but require high sterile conditions.

Biological safety cabinet class III

Specially designed for the handling of microbiological agents, when working with indige...

Wiped film evaporator

With wiped film distillation, a substantial decrease of boiling temperature is obtained by reducing the...

Pilot multi-stage distiller

If generating an scalable data and bring in results with small sample quantities of high-boiling...

Pilot wiped film distiller

Generate scalable data and results during the pilot tests with wiped film distillation,  distill ...

Pilot short path distiller

Generate scalable data and results during the pilot tests with short path distillation, distill o...

Laboratory multi-stage distiller

A laboratory multi-stage distillers that combines the wiped film and short path distillatio...

Laboratory wiped film distiller

Reach reliable conclusions testing the distillation of high-boiling or highly viscous materi...

Laboratory short path distiller

Get to reliable conclusions for the separation of high-boiling and heat-sensitive products u...

Horizontal thin film evaporators

Horizontal thin film evaporators can increase the residence time of the product and achieve...

Thin film dryers

Dry dissolved or slurried crystallizing or amorphous products to a pourable powder.

Short path evaporators

With short path distillation, a substantial decrease of boiling temperature is obtained by reducing th...

Compact laboratory freeze dryer

Particularly suitable for research centers requiring greater freeze drying capacity. Some of...

GMP freeze dryer

Designed to perform clinical trials, pilot, and small scale or large scale industrial drying processes, in ac...

Custom engineered freeze dryer

For either bulk format or liquid in vials, ampoules or syringes, the Lyomega units are design...

Pilot freeze dryer for scale up

Designed for biological, pharmaceutical and food products formulation and “scale up...

Ethylene oxide sterilization chamber

Designed for the terminal sterilization of temperature sensitive medical-health produc...

Superheated water shower autoclave

Specially designed for sterilizing large batches of parenteral solutions.

Steam and air mixture sterilization autoclave

Specially designed for sterilizing large batches of parenteral solutions.

GMP autoclave

When sterilizing and dealing non-thermolabile products, you will want to get a hold of those resistant to the te...

Saturated steam GMP laboratory autoclave

For processing a wide range of products: solid, porous and liquids in a laboratory...

Dry heat depyrogenation oven

Specially designed for the drying and sterilization of glass containers, vials or ampoules, and...

Aseptic barrier systems

Designed for sterile product and Potent API’s either with low or high OEL requirements.

Restricted-access barrier systems

Create a physical barrier between the operator and the product. More flexible than an iso...

Pure steam generator

Pure steam is mainly used in the pharmaceutical industry and in biotechnology for sterilization, water f...

Electrical pure steam generator

Pure steam is defined as the steam which when condensed becomes WFI quality water in accorda...

Sterility test isolators

Designed to avoid this risk and protect the product from both the process and externally generated f...

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Tell us about your production challenge

When selecting production equipment for a production plant, it is important to talk to someone with experience in your field. Our industry experts have experience with various industrial applications. We’d love to help you!
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Examples of biopharmaceuticals extracted from living systems are stem cell therapy, transplant tissue, human breast milk, or antibodies for passive immunity. Recombinant DNA technology is used for medicines such as growth hormone or insulin, monoclonal antibodies, or fusion proteins. Vaccines are grown in tissue culture, and for gene therapy, viruses are artificially manipulated to include desirable parts of genetic material.

Different approaches or treatments for different types of biopharmaceuticals. Cell-based therapy involves modifying a patient’s own cells or donor cells to fight disease. Blood cells are tightly regulated by an interacting network of biological proteins such as hormones, cytokines, and growth factors. Vaccines contain antigenic components for a specific pathogen in order to activate a patient’s immune system so that it has a memory of the invading pathogen and offers protection when encountered. In contrast, monoclonal antibodies target antigens and destroy them, which is used as a, for example, treatment for transplant rejection. And then, there is also the production of different serums, hemoglobin, and collagen, which are not considered conventional drugs.

Upstream and Downstream Biotech Solutions

Cell isolation, cultivation, cell banking, and culture expansion are called upstream processes. After the developed product is purified for the required density and ready to be harvested, production technology must meet the highest industry standard to ensure that medicines are safe and effective and move through the clinical development stage. Different types of bioreactor systems are used together with different systems for process control and monitoring. Using scaleable equipment from R&D to industrial capacity and implementing the right monitoring strategies, for example, CMC regulations will reduce time to market significantly.

After harvest, the production process moves into a downstream process to meet purity and quality requirements. Downstream processing is usually divided into cell disruption, purification, and polishing. (Ultra-)centrifugation is carried out to separate biomass. If the desired product is intracellular, the cell biomass can be disrupted in order to release the product and allow extraction. If the product is extracellular, the medium can be further concentrated. Or, if necessary, de-watering is done by vacuum drying or reverse osmosis. Finally, a purified product is usually mixed with desired excipients before being packed and ready to enter the market.

High performance liquid chromatography for biopharmaceuticals

BIA Separations is a manufacturer of monolithic columns used in high-performance liquid chromatography (HPLC). CIM monoliths are made of porous methacrylate polymers composed of interconnected channels that range in size from 1-6 μm. It is these channels that account for the media separation power and flow characteristics and ability to purify large biomolecules, such as large proteins, viruses, plasmid DNA, and immunoglobulins with their activity intact.

Controlling up to 24 parallel cultivations at once

Applikon’s micro-Matrix is a unique miniaturized bioreactor consisting of an orbital shaker and special microtiter plates. Each well is individually equipped with sensors and additional ports. Critical cultivation parameters like pH, dissolved oxygen, and temperature can be individually measured and controlled.

The micro-Matrix is a true scale down of small-scale bioreactors, and its PC-based human interface offers simple, intuitive interaction with each of the 24 bioreactors.

Safe processing and packing of biopharmaceuticals

The majority of biopharmaceuticals on the market are parenteral formulations and administered by direct injection usually distributed in single-dose vials or prefilled syringes. Product is provided either as a solution, or more commonly as a lyophilized cake, and strict requirements for product purity, activity, and shelf life dictate a very high standard for injectable drug packaging.

All injectables need to be evaluated for leachables that may have migrated over the product shelf life during formal stability testing. Many biotech products are lyophilized in the vial before the stopper and seal are introduced. Lyophilization, therefore, presents its own packaging requirements on vial shape and rubber enclosures.

Equipment for making bio-pharmaceuticals in action

Bioreactor monitoring and sampling

High pressure homogenization

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