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Maker - Product Challenge

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Changemakers

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

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

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

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

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

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

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

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

<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

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

Adaptable to any purification procedure

Detailed instructions supplied

Saves time in experimental phase

Cuts development costs

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

Chemical

Pharmaceutical

Industrial Purification Systems

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

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

Purification &ndash; Making.com

Industrial Purification Systems - 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

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

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

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

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

liquid

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

We open production technology to everyone

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

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

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

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

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

bia-separations-cimmultus-brochure-pdf

BIA-Separations-CIMmultus™-brochure.pdf

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

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

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

API making equipment must observe rigorous quality control standards across the entire manufacturing process. The pharmacodynamic properties of active pharmaceutical ingredients API make them highly sensitive to their environment, making API manufacturing and production a tightly regulated field.

Active pharmaceutical ingredients (API)

A pre-filled syringe or PFS is a single-dose disposable syringe that is supplied loaded with the substance to be injected. By using a pre-filled syringe filling machine, you can have excellent dosage accuracy due to the exact filling of medications. During administration, safety from potential contaminants is also ensured as they are directly injected after opening. To further minimize the risk of contamination, pre-filled syringes are often filled and sealed in a sterile environment using stainless steel equipment.

Pre-filled Syringes

After being used to contain the blood of martyrs after death or to store the anointing oil of French monarchs, today ampoules are the first choice in packaging injectables. You create ampoules by melting the glass tube into the desired shape and seal them at the neck by melting the top of the glass tube. The only way for you to extract the contents from an ampoule is by breaking the glass at its breaking point, making it perfect for single dose applications only.

Ampoules

The click and puff of inhalers is a universal signal for respiratory conditions. Inhalers quickly grew into preferred drug delivery systems for asthma and COPD. Dry inhaler powder formulation produces a more stable drug than liquid dosage forms. Moreover, inhaler ingredients are more resistant to bacterial growth.

Dry inhaler powder

Fully lockable protective panels and doors for secure and safe operation

Designed for simple upgrading of production rate

Choice of sophisticated control systems with inbuilt data logging and paperless chart recorder

Minimizes waste water

Flexible system integration with proven technologies

Industrial filtration equipment separates solid matter from liquid by using a filter medium. The filter allows only the fluid to pass through but retains the solid matter. The choice of filtration equipment depends on the particle size, the consistency of the mixture, and the nature of your product.

Filtration

The purified water systems from Telstar Life-Sciences are specially designed to generate purified water.

Highly Purified water is used in the preparation of medicinal products where bacterial endotoxins need to be controlled, except where water for injection

Purified water systems &ndash; Making.com

Sizes available with 6,9, and 12 mm ID

Reduces downtime from pump and tubing failure

Less prone to erosion with age meaning less downstream filter loading

Fully biocompatible

Robust and highly flexible construction make this the ideal tube for use in peristaltic pumps

A biosafety cabinet is an enclosed, ventilated workspace for safely working with materials potentially contaminated with pathogens in the laboratory. A laminar flow bench is an enclosed space designed to prevent contamination of sensitive samples; it draws in air through a HEPA filter and directs it smoothly towards the user to protect the sample from contamination. The choice of a suitable biosafety cabinet or bench depends on the type of sample and the defined biosafety level ranging from 1 (unlikely to cause disease) to 4 (causes very serious human or animal disease).

Biosafety cabinets

Industrial Pumps

The fermentation process stimulates enzymatic activity in organic substrates to transform their chemical composition. Fermentation is aided by storying the biomaterials in anaerobic environments, allowing the microorganisms to decompose their nutrient structures. The process is integral to some of the most popular products throughout time such as wine, beer, cheese, and kimchi. But besides the food sector, fermentation is also an important stage in the industrial manufacturing of chemicals, pharmaceuticals, and biofuels.

Fermentation

Formulation technologies are an integral process in many industries such as pharma and food. Chemical mixtures require strict handling to combine the separate ingredients into the homogenized recipe that makes your final product. Formulation technology stores, mixes and subjects the elements to a range processing parameters according to your specifications to develop the base material. The resulting formulas are then weighed, formed, packaged, or sent for further formulation.

Formulation

Tubing solutions specifically designed for use in peristaltic pumps in bioprocess production environments.

Sensitive bioprocess applications requires equipment that will not interfere with the chemical and biological processes being carried out.  At the same

Biocompatible tubing for peristaltic pumps &ndash; Making.com

Compatible with bags from any manufacturer

Single use bags avoid risk of cross contamination while using holder across different platforms

Integrated load-cells for local weighing or integrated process monitoring with other equipment

Retentate and permeate quantification for TFF processes

Mobile platform makes the system useful in transfer of bioreactor contents

Single-use technologies are increasingly being used in the biotech industry due to lower costs, lower risk of cross-contamination, flexibility, and convenience. A single-use bioreactor uses disposable bags instead of a culture vessel to carry out the bioprocess. Using disposable bags, instead of reusable bioreactors, can help reduce the setup time and the time between production cycles. It also reduces sterilization demands for vessel reuse, leading to significant cost savings. In addition to single-use bags, single-use sensors are also employed for efficient and low-cost bioprocessing. Single-use applications are especially suitable for the production of biopharmaceutical products.

Single use systems

Liquid

Industrial measurement equipment is used as a crucial step before products leave the production line. These measuring instruments check for correct dosage and standards. Equipment for measurement and control employs a wide range of technologies to detect inconsistencies in volumes, sizes, weights, and fill levels as well as to inspect goods for quality against a set of criteria. Specialized measuring tools allow you to minimize the probability for error to its lowest possible, ensuring that both products and packaging meet your benchmarks.

Measurement &amp; Control

Complex processes call for continuous tracking and monitoring systems that help you to keep the manufacturing operation under control. The technology analyzes the components in the production phase for divergence in behavior or changes in conditions. Based on advanced software applications, monitoring platforms make sure that your products satisfy the quality criteria while they are being developed.

Monitoring

Weighing

Scilog’s WeighStation system is a wheeled bag stand that works with single use bags from any manufacturer.

Single use bags for biopharmaceutical process containment and liquid storage are being used with increasing frequency in the industry due to their

Bag holder and weighing platform for bioprocesses &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.

Purification for biopharmaceuticals

Which purification for biopharmaceuticals equipment do you need?

Plasmid process pack for your pDNA purification process

Purification screening kit for large biomolecules

Pharmaceutical pure steam generator

Disposable monolithic columns

Short bed monolithic columns for analytics

Purified water systems

Biocompatible tubing for peristaltic pumps

Bag holder and weighing platform for bioprocesses

Wiped film evaporator

Pilot multi-stage distiller

Pilot wiped film distiller

Pilot short path distiller

Laboratory multi-stage distiller

Laboratory wiped film distiller

Laboratory short path distiller

Short path evaporators

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