Biopharmaceutical Production Technology

Find innovative production technology for making biopharmaceuticals and connect directly with world-leading specialists.

Biopharmaceuticals
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Biopharmaceuticals are drugs 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. Also known as biomanufacturing, 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.

Which biopharmaceuticals equipment do you need?

Complete bioreactor system

Complete bioreactor system

An autoclavable bioreactor establishes special conditions for a variety of applications, for examp…

Bioprocess control software

Bioprocess control software

Managing a large number of bioprocesses individually without automation is time-consuming, and th…

Bioreactor software

Bioreactor software

Comprehensive upstream data acquisition and management are essential in the bioprocessing industry. That’…

Single use bioreactor

Single use bioreactor

Single use, micro-bioreactors could be a good solution for replication processes, especially when they e…

Fully Automated On-Line Sampling for Bioprocesses

Fully Automated On-Line Sampling for Bioprocesses

Accurate sampling is a critical tool in the design and improvement of a …

Sampling probe for bioreactor samples

Sampling probe for bioreactor samples

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

Online fraction collector for offline bioprocess analysis

Online fraction collector for offline bioprocess analysis

Many bioprocesses require offline analysis of samples to monito…

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Online sampling system for larger scale bioprocesses

Online sampling system for larger scale bioprocesses

Accurate sampling is vital for improving a wide variety of industrial…

Automatic sampling system for bioprocess monitoring

Automatic sampling system for bioprocess monitoring

An accurate, automated sampling of cultures is a key requirement in th…

24 fully controlled bioreactors in a microtiter format

24 fully controlled bioreactors in a microtiter format

When undertaking a screening study, process development or optimisa…

Purification screening kit for large biomolecules

Purification screening kit for large biomolecules

To purify a specific large biomolecule, for example IgM or a virus or vi…

Automated dispensing system for bioprocesses

Automated dispensing system for bioprocesses

Biopharmaceutical manufacturers require precisely known liquid quantities for …

Bag holder and weighing platform for bioprocesses

Bag holder and weighing platform for bioprocesses

Single use bags for biopharmaceutical process containment and liquid sto…

Disposable tubing for manifolds in bioprocesses

Disposable tubing for manifolds in bioprocesses

Manufacturers in the bioprocessing industries are increasingly turning to s…

Y sets tubing for bioprocesses

Y sets tubing for bioprocesses

Manufactueres in the bioprocessing industries are increasingly turning to single use solutions…

Biocompatible tubing for peristaltic pumps

Biocompatible tubing for peristaltic pumps

Sensitive bioprocess applications requires equipment that will not interfere wit…

Disposable pillow bags for bioprocesses

Disposable pillow bags for bioprocesses

Manufacturers in the bioprocessing industries are increasingly turning to single use…

Disposable mixer bags for bioprocesses

Disposable mixer bags for bioprocesses

Bioprocessors must use ingredients of known high quality and consistency.  Inconsiste…

Normal flow filtration sets for bioprocesses

Normal flow filtration sets for bioprocesses

Bio-processors require reliable, high quality, easy to maintain, filtration eq…

Disposable manifold bags for bioprocesses

Disposable manifold bags for bioprocesses

Manufacturers in the bioprocessing industries are increasingly turning to disposa…

3D disposable bags for bioprocesses

3D disposable bags for bioprocesses

Manufacturers in the bioprocessing industries are increasingly turning to single-use sol…

Biological safety cabinet class III

Biological safety cabinet class III

Specially designed for the handling of microbiological agents, when working with indigen…

Biosafety cabinet class II for cytotoxic medicines

Biosafety cabinet class II for cytotoxic medicines

For the manipulation of hazardous substances utilized during the prepar…

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Microbiological safety cabinet class II

Microbiological safety cabinet class II

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

Single use bioreactor Hyclone

Single use bioreactor Hyclone

A single-use bioreactor is a bioreactor with a disposable vessel for culture of cells, instead …

Single-use bioreactor CellReady 3L

Single-use bioreactor CellReady 3L

A single-use bioreactor is quite simply a bioreactor with disposable vessel for culture o…

Single-use bioreactor Appliflex

Single-use bioreactor Appliflex

A single-use bioreactor is a bioreactor with a disposable bag instead of a culture vessel, co…

Mini bioreactors

Mini bioreactors

When a screening study takes place, optimizing media process and working with microbial and cell cultures is q…

Steam-in-place bioreactor systems

Steam-in-place bioreactor systems

Scaling-up from a laboratory scale to pilot plant and small scale production can be simpli…

Scalable bioreactor controller

Scalable bioreactor controller

When you are up-scaling bioprocesses, starting at the lab and going all the way to the pilot a…

Small-scale bioreactor controller

Small-scale bioreactor controller

When you are working with small bioreactors, starting from 50 ml volumes, you need a good …

Lab scale Bioreactor controller

Lab scale Bioreactor controller

Success with bioprocesses is all about controlling the environmental conditions controls so y…

Photobioreactor for plant growth

Photobioreactor for plant growth

SSL (Solid state lamps) plant light has unique and useful characteristics for plant growth a…

Autoclavable stainless steel bioreactor

Autoclavable stainless steel bioreactor

For cell culture and microbial culture applications.

Autoclavable glass bioreactor

Autoclavable glass bioreactor

Especially designed for cell culture applications and research applications such as process opt…

Stories about biopharmaceuticals

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Modify biopharmaceutical extracts to stimulate antibodies with vaccines

Recombinant DNA technology is used for medicines such as growth hormone or insulin, monoclonal antibodies, or fusion proteins. As part of their manufacturing process, 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. An example of this would be Covid vaccines. In contrast, monoclonal antibodies target antigens and destroy them, which is used for other purposes such as treatment for transplant rejection. Finally, biopharmaceutical extracts are also used for the production of different serums, hemoglobin, and collagen, which are not considered conventional drugs by the FDA.

Purify the extract during downstream preparation of biopharmaceuticals

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 scalable 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.

Cultivate the media in a bioreactor

A bioreactor mixes the cell media together in a sterile, pressure-free environment. A main component of bioreactor systems is the agitator that facilitates the bundling of contents, facilitating the reactions between them.

One of the primary challenges of bioreactors is controlling the center of gravity. An integrated baffle arm minimizes the formation of internal vortex effects that cause this while keeping the temperature at a constant.

 

High performance liquid chromatography for biopharmaceutical manufacturing

High-performance liquid chromatography (HPLC) offers high-accuracy separation using columns. 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.

Safe processing and packing in biopharmaceutical manufacturing

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. These analytics are crucial when it comes to biopharma manufacturing.  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. Contact us to find out more about the biopharmaceutical technology that is right for your production needs.

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