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Separation technology for biopharmaceuticals

Cell culture has been, over a little more than 100 years, an important method of research in laboratories. But medicine developments aside, we wonder if even the most positive of idealists could have also believed that cell cultures and tissue culture would possibly change the way – and what – we eat. From the lab to the dining table, there’s cell culture equipment to make even the unimaginable possible.

Cell cultures

Glycerine is a water-soluble liquid mix of alcohol and sugar. It is a by-product of the oil and fats industry that offers added value to various industries. There are three ways to process it: transesterification, saponification, and fat splitting (hydrolysis). In 2020 these 3 forms of glycerine production reached around 4 million metric tons, with a global market of $1.68 billion.

Glycerine

Insulin is a hormone that controls blood glucose levels produced by the beta cells in the pancreas. As a medication, insulin was discovered by Frederick Banting and Charles Best in 1921, for which Banting was awarded a Nobel Prize in 1923. The insulin production process involves manipulating the biological precursor to insulin and cultivating it inside bacteria using specialized technology.

Insulin

The word parenteral comes from Greek and means outside the intestine (para=outside and enteron=intestine). In fact, when it comes to parenterals, we are referring to those dosage forms that are administered directly into the bloodstream using a hypodermic needle, avoiding going through the gastrointestinal tract. Using parenteral filling equipment, parenteral solutions are placed in containers such as vials, syringes, or ampoules.

Parenterals

Pharmaceutical cartridges are glass containers of cylindrical shape, suitable for liquid or solid pharmaceutical dosage forms. Generally, these are designed for a specific apparatus such as pre-filled syringes and autoinjectors. Drugs that can be placed in cartridges using a pharmaceutical cartridge filling equipment include insulin, dental anesthesia, and other emergency drugs for allergies.

Pharmaceutical cartridges

<em>“How clean does my equipment needs to be?” </em>That's what manufacturers often wonder about in order to meet the high sterilization standards the pharmaceutical industry demands. Lending manufacturers helping hand have been single-use bags, also known as disposable, first introduced in the late 1990s. They immediately gained popularity because they reduce the risk of cross-contamination, minimalize cleaning and sterilization demands, and require a low capital cost.

Single-use bags

Some of the vaccines in use today were originally developed decades ago. But advances in research, expertise and vaccine development equipment provide immunizations from bacterial and viral diseases (antibodies and cell therapy) to more people every year. The Covid 19 pandemic highlights the urgent need to scale up the production of vaccines and ensure an automated as well as reproducible manufacturing environment.

Vaccines

During crime scene investigations in any movie, you've probably seen forensic scientists collecting evidence and biological samples in small containers. Here, these are the vials, used to store medicines, especially in liquid form, or laboratory samples. Often made of glass or plastic, vials can be labeled as single-dose vials or sterilized and reused more than once. They are also available with various closure systems depending on the material and storage requirements.

Vials

If you've ever heard the acronym WFI spoken, know that we're not talking about wireless technology to connect your computer. WFI stands for water for injection, a sterile water used as a solvent to dilute other solutions for injections to the body. Traditionally, WFI was only produced through the distillation process using water for injection equipment until other methods such as reverse osmosis, electrodeionization, and ultrafiltration were developed.

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Water for injection

Flexibility of using purified, superheated or injection water

  Outputs pure dry, saturated steam

Runs on steam or electric power

  Simple, single boiling column technology

Variable output across a wide range controls cost

Pharmaceutical

Industrial Separation Equipment

Industrial separation equipment encapsulates the separation process which is to separate components of a liquid mixture, for recovering dissolved solids from liquids. The choice of a suitable technology depends on the identification of the key physical or chemical property, such as size, mass, density, or boiling point, which sets the product of interest apart from the rest of the components. Separation technology is widely used in the pharmaceutical and chemical industries for the isolation of active ingredients and high-purity chemicals. As well as in waste management and recycling industries.

Separation

Connect directly with world leading manufacturers of industrial separation equipment and find technology to build or improve your production line.

Separation &ndash; Making.com

Industrial Separation Equipment - Making.com

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.

Biopharmaceuticals

Parenteral preparations refer to drugs using non-oral means of administration. Injectables, such as needles and syringes, are used to deliver a drug into the systemic circulation directly in the veins, muscles, under the skin, or in the tissue.

These parenteral formulations are pharmaceutical dosage forms that have strict regulations on being sterile, pyrogen-free, and free from visible particulate matter including reconstituted sterile powders. Solutions, suspensions, emulsions, and gels with APIs intended for administration by injection are usually supplied in vials, ampoules, pre-filled syringes, or pens to facilitate ease of use.

Injectables

Pharmaceutical powders provide longer shelf life and better stability than liquid dosage forms. But the processing of pharmaceutical powders is crucial for growing segments besides pharmacy. Functional foods and cosmetics formulated with active ingredients and excipients depend on powdered forms to fulfill their promises.

Pharmaceutical powder

Pharmaceutical developments walk side by side with health advances to provide new medicines, treatments, and therapies that have increased life quality and extended life expectancy by years. Pharmaceutical manufacturing equipment helps deliver products to a great deal of the population, but there’s a significant share that doesn’t benefit from them yet. Over 2 billion people cannot get the medicines they need, according to the United Nations Industrial Development Organization, and local production might be a way to provide for these people.

Pharmaceuticals

Process

Continuous

<span style="font-weight: 400">The heating process is a step of raising the temperature of food, pharma, cosmetics, and many other types of products. You may employ different heating solutions for this process, depending on the type of product you intend to manufacture. Selecting the appropriate heater machine for your product is quite important since various products require different ranges of temperatures and different ways of heat transfer using exchangers. Industrial heating equipment varies in two ways - the type of material it can process and the reaction you want to achieve.</span>

Heating

Purification is the removal of contaminating substances and by-products to increase the level of purity of the desired substance. Considerations for choosing a suitable purification system in the industry, include the physical state of the mixture, the desired product, required level of purity, the type of mixture, heat sensitivity of the product, number of purification steps needed, and the production volume. Industrial purification systems are used for the production of pure water in the food pharmaceutical and biotech industries.

Purification

liquid

Dry, saturated steam can be used to sterilise pharmaceutical manufacturing equipment, and active pharmaceutical ingredients. The water should be

Pharmaceutical pure steam generator &ndash; Making.com

We open production technology to everyone

Making.com

bia-separations-cimmultus-brochure-pdf

BIA-Separations-CIMmultus™-brochure.pdf

Ancient civilizations were using yeast as it naturally occurred in bread-making and brewing. But yeast processing equipment wasn't developed and fully commercialized until the end of the 18th century. Today, this industrialized micro-organism is critical in producing biofuels and other products beyond food and drinks.

Yeast

The billions of microbes living in our gut have a significant impact on gastrointestinal health, mood, and behavior. Every individual develops their microbiome community. Probiotic processing technology makes sure that harmful bacteria never outnumber good citizens.

Probiotics

Economical as single or multi-use device (intra-batch or inter-batch use)

Reduced back pressure and minimal sample clogging

Fast product isolation and concentration of diluted samples

Efficient removal of high molecular mass impurities in polishing steps

cGMP Compliant

Sampling is the process of aseptically drawing a sample from the process for analysis, without disturbing the bioprocess itself. The bioprocess needs to be carefully controlled by measuring important process variables and parameters. These parameters include pH, temperature, dissolved oxygen, foam/level, and agitation. The controllers use PID or auto-tuning adaptive control to measure and regulate the process parameters. The choice of a suitable controller depends on the identification of critical process variables.

Biotech sampling and control

Monolithic columns allow fast, efficient, and reproducible separation of biomolecules such as proteins, plasmid DNA, antibodies, and viral particles, from samples taken at various stages during a bioprocess. Choosing a monolithic column involves considering the desired column volume and length, the flow rate through the column, construction of the housing, and interface to the HPLC equipment. Monolithic columns are used in the pharmaceutical process development for reaction monitoring, column fraction screening, and analysis of mother liquors and unstable analytes.

Monolithic columns

Chemical

Due to their potential hazardous nature, chemicals are classified for proper identification and safety during production. Chemical classification depends on their properties, structures and functions. In the chemical industry, you can regard them as basic chemicals such as acids, chemical products to produce plastic materials and finished chemicals for use in cosmetology. As a manufacturer or engineer, you want to know their reactivity when using chemical processing equipment.

Chemicals

R&amp;D

Batch

Biotech equipment is used for cellular and biomolecular processing to develop products that improve our lives and the planet. With the help of specialized lab equipment, the active substance is manufactured or extracted from biological origin materials and typically produced in bioreactors by plant cells, microbial cells, yeast cultures, or mammalian cells. Cell isolation, cultivation, cell banking, and culture expansion are called upstream processes. After harvest, the production process moves into a downstream process to meet purity and quality requirements which is divided into cell disruption, purification, and polishing. Biotechnology equipment makes use of various laboratory machinery such as bioreactors, centrifuges and incubators.

Biotech

CIMmultus™ disposable monolithic columns from BIA Separations make a perfect choice for the purification of viruses, VLPs, plasmids and antibodies.

Chromatographic monolithic columns for working with large proteins, viruses, VLPs and pDNA require the high structural strength and contamination

Disposable monolithic columns &ndash; Making.com

bia-separations-cimac-brochure-pdf

BIA-Separations-CIMac-brochure.pdf

Speeds up method development and analysis time

Works even with only very shallow linear gradients

Flow rate can be changed without sample deterioration

Enables regeneration and cleaning under extreme conditions

  Low sample and buffer consumption

Chromatography systems

CIMac™ Analytical Columns from BIA Separations are short bed, high performance monolithic columns offering all the advantages of CIM® monolithic technology

Samples taken at various process steps need to be analysed quickly and accurate results delivered, without affecting the state or condition of the

Short bed monolithic columns for analytics &ndash; Making.com

Adaptable to any purification procedure

Detailed instructions supplied

Saves time in experimental phase

Cuts development costs

BIA Separations' CIMmultus™ HiP2 Plasmid Process Pack™ is intended to help scientists develop their pDNA purification process and transfer it to production

When developing a pDNA purification process for eventual transfer into production, efficient examination and selection of protocols is critical. Develop

Plasmid process pack for your pDNA purification process &ndash; Making.com

Prepacked columns, ready for use

Screens for a range of large biomolecules

Facilitates high speed purification

Highly economic process

Screeners

The CIMmultus™ Purification Screening Kit from BIA Separations helps scientists discover the optimal stationary phase of chemistry for their application.

To purify a specific large biomolecule, for example IgM or a virus or virus-like particle, the first step is to screen the working conditions. Different

Purification screening kit for large biomolecules &ndash; Making.com

The humble chamomile flower holds a rich blend of compounds that soothe body and mind. A natural antidepressant and anti-inflammatory, chamomile oil found its way into the earliest pharmacopeia. As more of its properties were discovered, the oil became an elemental ingredient for a vast range of pharmaceutical and cosmetic recipes. Chamomile oil processing equipment developed at the same speed, offering manufacturers multiple production techniques to extract the liquid from the precious flower.

Chamomile oil

Echinacea, also known as coneflowers, are brightly hued flowers with distinguished, cone-shaped flower heads. Over 200 medicines in the world are derived from coneflower extracts. Echinacea processing was introduced by Native Americans who were interested in the plant's medicinal qualities.

Echinacea extract

Elderberry falls squarely in the category of superfoods. Every part of the plant (flowers, berries, and bark) is loaded with vitamins, antioxidants, bioflavonoids, and other compounds. However, cyanide in the plant could be lethal if consumed raw, making elderberry extraction processing complex.

Elderberry extract

What’s the only living connection between our present world and the age of dinosaurs? The ginkgo biloba plant. Also known as the maidenhair tree, it is regarded as a living fossil and has been around for more than 200 million years. Ancient civilizations in China were already mastering ginkgo processing centuries ago and the tradition soon flourished around the world.

Ginkgo extract

Panax ginseng is a medicinal plant with a long history steeped in myth. The term “panax” itself is derived from a Greek word for “panacea” or “cure all”. As ginseng processing technology continues to develop, this famous traditional extract keeps finding new applications.

Ginseng extract

Lavender oil is one of the most common essential oils in the market currently. Extracted from the herb Lavandula spp., this essential oil is used as a complementary medicine and as an additive. Studies have shown that lavender oil has sedative, carminative, anti-depressive, and anti-inflammatory properties. Like other essential oils, lavender oil extraction equipment must be capable of distillation, condensation, collection, and separation processes.

Lavender oil

All plastics are polymers, but not all polymers are plastics. Polymer production is a multi-step process that transforms raw materials into products that we use in our day-to-day life with the help of polymer process equipment such as extruders, calenders and injection molding machines.

Polymers

Rose oil is an essential oil extracted from the petals of either Rosa damascena and Rosa centifolia. Also known as liquid gold, rose oil production originated from Greece and is currently manufactured mainly in Bulgaria, Turkey, and Morocco. Studies have shown that rose oil has medicinal properties, exhibiting anti-inflammatory, anti-infective, and wound healing actions.

Rose oil

The ancient Greeks believed feeding sea buckthorn to their horses would give them a lustrous hide. Indeed, full of lipids and carotenoids, the fruit did contribute to glowing, reddish coats. However, the thorny plant also has benefits for humans. Sea buckthorn processing equipment extracts this unique vegetable oil full of fatty acids. The liquid is a prominent component in various food, cosmetic, and pharmacological preparations.

Sea buckthorn oil

When he was in Haiti in 1493, Christopher Columbus noticed that the natives were bouncing on rubber balls made from the milky sap of Hevea brasiliensis, also known as a rubber tree native to South America. The milky sap was nothing but latex, the source material for natural rubber. Latex processing technology includes equipment for coagulation techniques and rollers for natural latex and a sequence of mixers, pumps, and sieves for synthetic latex.

Latex

Continuous distillation process

Short residence time

High evaporation rates

Low fouling on evaporator wall

  Can be combined with a column to increase the number of theoretical plates

Food

Cannabinoids are natural compounds obtained from the Cannabis sativa plant. Delta-9-tetrahydrocannabinol or THC is a psychotropic substance. Cannabidiol, or CBD, is non-psychotropic and often used for nutraceutical purposes. Cannabinoid equipment extracts THC and CBD from the plant and prepares the substance for formulations that treat pain, nausea, anxiety, and inflammations. Cannabinoids are processed in various forms, including creams, capsules, and oils.

Cannabinoids

Essential oils are known as the liquid gems of nature. The sweet-smelling essences impact not just our senses but also our biochemical and cellular make-up. Besides aromatherapy, the products of an essential oil extraction system found applications in pharmaceuticals and foods.

Essential oil

Our food chain starts in the soil, growing crops and livestock. But between the fields and the stores, there is a line of industrial food processing equipment. Processes may be as minimalistic as cleaning fruit and as complex as homogenizing milk alternatives made from pressed legumes. In each case, processing technology is an important link in the food production chain.

Fruit pulp is a mass of pressed fresh fruit not meant for immediate consumption. Production of fruit pulp avoids wasting food and preserves the flavors and nutrient value of the fruit product. Processed fruit pulp is an ingredient in beverages, sauces, baby foods, jellies, smoothies, and bakery products.

Tradition and manufacturing procedures dictate the distinction between fruit juice, puree, and pulp. Still, naming and labeling are complex and depend on regulations, type of fruit, texture, consistency, preservation methods, and sugar or solid content (measured in Degrees Brix). Depending on your desired output, there are various fruit pulper machines for different stages of production that make the process quicker and more efficient.

Fruit pulp

Ancient civilizations discovered that plant extracts were useful for the treatment of pathologies. The origin of plant extraction cannot be specifically verified, but we can infer that the earliest attempts at plant extraction were more intuitive than scientific. Today, the extraction of compounds is a precise process with plant extraction systems complimenting traditional knowledge.

Plant extracts

Can it be said that we live in the Plastic age? Basically, yes. From pillows over toothbrushes, and packaging to utensils, plastic is a widely used material in our day-to-day lives. But what is it? Plastics are synthetic or semi-synthetic materials built of polymers that are easily shaped into various structures with the help of plastic processing equipment such as extruders and molders.

Plastics

Evaporation technology is used to reduce or remove the moisture content of a mixture. Considerations for choosing suitable evaporation equipment include the moisture content in the mixture, the boiling point of the solvent, heat sensitivity of the product, and the amount of material to be processed. Evaporators are used for applications such as obtaining fruit and vegetable concentrates in the food industry, concentrating aromas and herbal extracts in the cosmetics industry, and isolating active ingredients in the pharmaceutical industry.

Evaporation

Separate high-boiling and highly viscous materials in a wiped film evaporator.

With wiped film distillation, a substantial decrease of boiling temperature is obtained by reducing the operating pressure. It is a continuous process

Wiped film evaporator &ndash; Making.com

Only one percent of the entire plant species on the planet produces essential oils, but that amount has found its way into various products, from perfumes to foods. Flower extraction systems are similarly diverse, and picking the right ones depends on the organic material and the final product.

Flower extract

Tea tree oil, also known as melaleuca oil, is an essential oil with immune system stimulants produced mainly in Australia. The tea tree oil manufacturing process starts from the leaves of Melaleuca alternifolia. In terms of market value, the one for tea tree oil was valued at 38.8 million USD last 2017 and is projected to increase to 59.5 million USD by 2025.

Tea tree oil

Everything tastes like porridge, the saying goes. That may be an exaggeration, but in theory, reaction flavors could make everything taste the same. Thankfully, flavorists and chemists in the flavor industry are more inventive than that, and colorful process flavors treat our taste buds to a broad palette of sensations, flavors and aromas.

Reaction flavors

Fish oil was a folk remedy long before scientists identified the nutritional value of essential fatty acids. But Omega 3 processing has come a long way since the days of raw fish parts fermenting in a barrel. In fact, new supplement formulations of polyunsaturated fatty acids (PUFAs) may not use fish at all.

Omega 3 oil

Processing of high-boiling, high-viscosity or crystallizing product are possible

Can be operated at pressure range of 0.1 mbar to 1,000 mbar

Can be combined with additional evaporation stages

Wiped film distillers

Industrial distillation equipment is used in the process of separating different constituents of a liquid mixture. Considerations for choosing suitable distillation systems include the boiling points of the components, heat sensitivity of the product of interest, pressure requirements during the process, and the scale of production. Distillation is used for concentrating extracts such as herbal extracts, flavors, and aromas in the food industry. In the pharmaceutical industry, distillation is used in the production of active ingredients and in the chemical industry for the purification of chemical products.

Distillation

Pilot wiped film distiller units are used to process small product quantities that will enable a later scale up to an industrial system.

Generate scalable data and results during the pilot tests with wiped film distillation,  distill or dry of small product quantities with as little as 30

Pilot wiped film distiller &ndash; Making.com

Koala bears diet exclusively on eucalyptus leaves. But the large concentration of cineole in the tree keeps most other predators at bay. Humans, though, discovered ways to extract the substance and use it as a remedy against inflammations and other diseases. The eucalyptus oil production process keeps evolving to maximize yields, ensuring enough eucalyptus forests for koalas.

Eucalyptus oil

Mineral water is mother nature’s cocktail of dissolved solids. The concentration of essential chemicals in the water makes it an excellent source of nutrients and electrolytes. Although your bottled product retains most of the properties present at its natural condition, the water still needs some help before it can be safely consumed.

Mineral water

Can be configured based on customer's requirement

PLC and visualization option can be selected

Can process temperature sensitive high boiling products

Can handle viscous and fouling products

Short Path Distillers

The VTA Laboratory multi-stage distiller is a combination of the short path and wiped film distillation technique.

A laboratory multi-stage distillers that combines the wiped film and short path distillation technique allows you to test the separation of high-boiling,

Laboratory multi-stage distiller &ndash; Making.com

Oleochemicals

Provides visual observation of the distillation process

Proper and reliable tests can already be performed with 2 kg of crude material

Can handle material with max. Viscosity of 15,000 mPas (cP) at operating temperature

Options of continuous feeding systems and continuous discharging systems for distillate and residue can be selected

The VTA wiped film distillation laboratory unit is designed to distill small product quantities for acquiring reliable data of the separation process.

Reach reliable conclusions testing the distillation of high-boiling or highly viscous material using as little as 2 kg of crude material. Small scale

Laboratory wiped film distiller &ndash; Making.com

A variety of size selection is available based on customer's requirement

Continuous feeding systems and continuous discharging systems for distillate and residue options can be selected

The VTA Laboratory short path distiller integrate the short path distillation technique and are set-up as modules.

Get to reliable conclusions for the separation of high-boiling and heat-sensitive products using as little as 2 kg of crude material. Small scale thermal

Separation technology for biopharmaceuticals

Which separation technology for biopharmaceuticals equipment do you need?

Pharmaceutical pure steam generator

Disposable monolithic columns

Short bed monolithic columns for analytics

Plasmid process pack for your pDNA purification process

Purification screening kit for large biomolecules

Wiped film evaporator

Pilot wiped film distiller

Laboratory multi-stage distiller

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