Frequently Asked Questions

Move towards in-vitro testing tools! Working in-vitro reduces – and in some cases replaces – the need for animal testing, whilst also providing data in a faster and more efficient way, reducing time and financial costs associated with drug development. Pion produces a range of in vitro tools to help with the various stages of drug development. Browse our products for more information.

‍

Although Pion does cover the majority of parts under warranty and high-level service contracts there are some parts that are not covered or have limited warranty. In most cases, any part that comes into contact with media or solution are not covered as part of the warranty. This would include items like Fiber Optic probes, glass syringes, o-rings, and fluidic lines. If you have questions about coverage please contact your local service representative.

Standard homogenizer systems come with highly compatible seal materials. However for particularly aggressive solvents that may have chemical compatibility concerns, alternate seal materials may be installed to accommodate product needs. Pion is happy to offer solutions to any product demands.

Yes. We have developed a series of training videos to help support our BEE homogenizer customers. They may be found at:
‍Customer Training Videos - Homogenizers (pion-inc.com)

Yes. We've developed a series of videos to help support our customers who are using our Rainbow Fiber Optic Dynamic Dissolution System in its various configurations for dissolution and flux studies. These videos may be found at: Fiber Optic Customer Training Videos (pion-inc.com)

Our Dual Feed option allows the user to sequentially add ingredients during the in-line process to incorporate hard and abrasive materials with over 80% solids. The Dual Feed port, which is located after the nozzle on the EC, creates a natural vacuum that incorporates these materials into a high velocity jet stream while avoiding wear including non-VOC polymer and resin emulsions. Also, our Reverse Flow and Dual Jet options are utilized for applications that require with maximum shear and process duration in one pass. Lastly, extremely viscous materials can be processed with over 100,000 cP.

Yes. Pion Inc. offers a flexible and cost-effective rental program that allows the perspective user the opportunity to fully test a DeBEE homogenizer at their facility.

Yes. Please contact us for more information on controlled drugs and logistics for testing.

‍

Yes. It is common practice for customers to ship or hand-deliver product samples to Pion Inc. for testing and analysis. Customers are required to fill out an Application Questionnaire that details and describes their application requirements, product characteristics, and processing conditions. Our laboratory testing is a cooperative process where we strive to produce unprecedented results with your product using the most optimal configuration of our patented and modular homogenizing cell.

Yes, we offer a wide range of services based on the criticality of the instrument to your testing. Reach out to your local sales or service personnel to learn more about these offerings.

There’s no formal requirement, but Pion does recommend annual PM or PM prior to any qualification activities.

Not necessarily – while there’s often a direct correlation between higher process pressure and smaller particle size, each product will have different characteristics and may respond better to various process parameters. Having the full range of operating pressure available for experimentation allows a user to maximize their R&D potential.

High pressure homogenizers are used in pharmaceutical formulation to create stable emulsions, dispersions, and suspensions. The high pressure exerted by the homogenizer helps reduce particle size, improve mixing, and achieve uniform distribution of active pharmaceutical ingredients in the formulation. This results in increased bioavailability, stability, and efficacy of the final pharmaceutical product. High pressure homogenizers are also used to lyse cells and extract intracellular components, as well as to break down and homogenize tough tissues in pharmaceutical development and production processes.

At Pion, we create entirely animal-free tools and methods for pharmaceutical drug testing. We create in vitro instruments which simulate certain important factors which can affect a pharmaceutical drug upon delivery into a human. Scientists can use our various technologies to aid with drug development, providing alternatives to unrepresentative animal models traditionally used. Click here to find out more about these technologies.

Pion products are ideally suited to compare generic/ biosimilar formulations against the originator product. We provide offerings in vitro for dissolution, FLUX, absorption, physicochemical characterization as well as subcutaneous injectable testing which can provide platforms for direct comparison. Click here to see which products suit your needs.

‍

The Pion Scissor instrument is specifically designed to test drugs intended for subcutaneous injection in a completely animal-free in-vitro setting. The system is made to mimic the environment upon subcutaneous injection allowing scientists to compare formulations and better understand their likelihood of success in vivo. Click here for more information.

This depends on factors such as product characteristics, batch size, and frequency of use so there is not a one size fits all answer. We have chosen high pressure seal materials based on performance and longevity, and our systems are designed to be easily serviceable and disassemblable to keep service costs down. Typically, Preventative Maintenance visits by a certified service technician are recommended to ensure the equipment is in good working order and your users are up to date with the latest training. We offer Service Level Agreements that include parts and travel costs for your convenience.

The membrane is made of polycarbonate, which has been accepted to be bioinert. If there is ever any concern over the reactivity of this material, Pion can substitute other materials onto the cartridge in a case-by-case basis.

This is one of SCISSOR’s use cases – SCISSOR has been previously validated to demonstrate that mAb-based formulations exhibit a rank-order behavior in vitro that correlates with a clinical response. This means that we can continue along knowing that observations in SCISSOR will be dependent on clinical behavior of the formulation, however, in-depth analysis of these observations (in addition to in silico methodologies) will be needed for a true prediction of clinical response.

The common applications are particle size reduction, fine emulsions, cell disruption, dispersions, nanoparticles, liposomes, grinding, and micro-encapsulating along with general blending and mixing. Our Pion Inc. product line covers laboratory applications to pilot plant installations to high volume production systems.

The term ‘in vivo’ refers to a test, study, or procedure that is performed within a living organism while “in vitro” describes activity that is done outside of a living organism.

In vivo pharmacology is the study of the biological effects of a compound on an organism. It can help  researchers assess how diseases or tissues will respond to a certain drug.

To learn more about our technology, visit our Resource Library.

Pion traces its origins back to 1989. Our founders were working for a US company that was involved in in developing of ion selective electrodes, automated pH meters and titrators. They realized that automated titration could be used in the pharmaceutical industry for pKa and logP measurements and could help scientists achieve answers for their drug characterization questions. So, they quit their jobs and moved to the UK to co-found a company called Sirius Analytical Instruments. In 1996 one of the founders returned back to the US to co-found Pion Inc (spelled pION at the time).

Pion and Sirius maintained a close mutual distributorship relationship and both continued to add new instruments and services in their portfolios. In 2002 Pion had acquired company called Delphian Technologies that opened its access to the in situ fiber optic UV measurements that is currently one of Pion’s core technology.

In 2003 Pion and Sirius parted ways. In 2011 new owners acquired the Pion business in the US. Pion acquired equipment service company Vortex, in 2016, before finally acquiring Sirius in 2017 and re-uniting the complementary set of technologies developed by the two companies under the Pion name once more.

On December 12, 2022, Pion acquired Two Square Science, a company specializing in sample preparation, content uniformity and remote monitoring solutions for the life science industry. The acquisition will add PrepEngine, a flexible, productive life science processing platform to the Pion portfolio for in vitro drug characterization, along with high performance monitoring equipment for the lab environment. These capabilities will help customers access richer, more relevant data to accelerate drug development and minimize reliance on in vivo studies.

On December 22, 2022, Pion acquired Best Emulsifying Equipment (BEE) International, a provider of ultra-high pressure homogenization technology solutions, adding homogenization capabilities to integrated, in vitro solutions for accelerated drug development.

When you work with Pion, you will get:

Unrivalled Technology

We use modern facilities and scientific equipment to deliver world-class formulation development services.

Dedicated Team

We are at the forefront of analysis, field service, and pharmaceutical laboratory instrumentation. Our formulation development specialists have the skills and training to help you develop compliant and optimal dosage forms.

Exceptional Quality

Our U.S. center of excellence for production is ISO 9001:2015 certified, meaning all our products and services meet customer needs through a quality management system.

Learn more about and products for the pharmaceutical industry here.

The SCISSOR platform has been validated for use within the subcutaneous injectable pipeline. However, there are customers using the instrument for intermuscular injections, and, depending on the application, Pion can increase the collagen concentration to warrant a more ‘muscle-like’ environment. Contact us for more information.

2000 hours or one year, whichever comes first.

Depending on the lamp, one of two things will happen. Either the lamp energy, especially in the UV, will decrease significantly as seen in the 100%T or the lamp energy will be unstable and will cause a sinusoidal pattern in the experimental data.

Pion has assisted many customers in moving to mechanical qualification from PVT testing. We offer services to perform the mechanical qualification and our experts can ensure you have all items needed to be successful in the transition.

The efficiency of energy transfer is critical as fluid flows through the homogenizing chamber. Our patented modular and configurable homogenizing cell has no wearable or moving parts and allows the user to quickly fit the homogenizing cell to meet their process requirements. Other conventional high pressure homogenizers use a fixed length orifice and fixed distance between the orifice exit and the impacted surface of the machine. There are no methods to adjust, modify or control the length and time of the flow pattern. If the provided energy is varying, the flow velocity and temperature are adversely affected. Also, processing concerns over cavitation and backpressure within the fixed interaction zone can dramatically impair the particle size reduction. To overcome these limitations, the modular and configurable DeBEE Absorption Cells (ABC) can be optimized according to operating conditions and process objectives by the combination of length, diameter and other parameters. A metering valve can be installed after the ABC to control backpressure. Therefore, the relationship between the particle size and increasing pressure is a downward straight line. By adjusting the homogenizing energy through a configured ABC, manufacturers can achieve their processing goal quickly by controlling pressure, flow cavitation, impact, shear and process duration.

Consistency of applied energy is critically important under high pressure. Our patented pumping system differs from the commercial triplex plunger pumps utilized by other high pressure homogenizers. The discharge characteristics of mechanical reciprocating multiplex pumps inherently vary and fluctuate with flow and pressure. Pion Inc. has developed a proprietary pump for heavy duty, long life cycle and leak-free service in a wide range of applications including sanitary conditions. Our DeBEE intensifiers are hydraulically actuated and microprocessor controlled to deliver a consistent pressure and flow to the DeBEE homogenizing cell. Particle size and particle size distribution are determined by the consistency of flow and pressure applied.

We allow for passive diffusion of glycosaminoglycans through the cartridge during injection, so 0.4mL and 0.8mL injections would occur in a filled ECM cartridge. However, as the 0.8 mL injection would take up more space within the cartridge, there would be fewer potential interactions that dictate the behavior of different pharmaceuticals (akin to lesser plates in a chromatographic method). Pion would suggest lessening the injection volume to a maximum of 0.5 mL, with a preference for smaller volumes.

Pion offers two different software packages. AuPRO is used for research and method development. DissoPRO is our compliant package which includes audit trails, user privileges, and user passwords.

In vitro imaging provides a comprehensive picture of the biological effects of a drug or treatment. The organism is kept alive meaning future analysis can be performed on the same subject. In addition, real-time biological changes can be detected and followed. In vitro imaging also involves a generally undisturbed process which helps in producing more accurate results.

Learn more about our products here.

We always start with ensuring a clean blank. Our technicians can then determine if new reagent preps are needed or if there is a hardware issue. Many times it is a simple fix and if hardware is needed we offer on-demand services to get you back up and running.

Pion offers unique instruments and services designed to empower scientists in making informed decisions throughout the entire lifecycle of food and drug formulation, spanning from Research and Development (R&D) to Manufacturing. Our commitment lies in assisting users to gain a comprehensive understanding of critical properties such as dissolution, solubility, permeation, ionization, and absorption of their compounds and drug products.

Additionally, we provide dependable and consistent process solutions tailored for R&D purposes, as well as sample preparation solutions for content uniformity, analytical, and mixing testing. Pion stands as a supportive partner in research endeavors, delivering scientific instruments, analytical services, and equipment that ensure the precision of results needed for more predictive decision-making within the drug development process.

Solubility: depends on a variety of factors such as temperature, pH, pressure, and nature of solute and solvent.

Surface activity: Surface active agents influence drug absorption which is based on the surfactant’s chemical nature and concentration.

Partition coefficient: affects the way the drug gets transported from the site of application to site of action.

Ionization of drug: depends on its pKa & pH: Ionization influences the degree of penetration of a drug through membranes.

Protein binding: Depending on whether it’s acidic or basic, a drug can either bind to multiple or single blood proteins.

Hydrogen bonding: a crucial parameter in the formulation of drugs, hydrogen bonding is classified into two types: intermolecular and intramolecular.

For more information on our solutions, click here.

Dissolution testing is a vital part of the drug development process. A dissolution test measures the extent and rate of drug release from a specified dosage form. During the test, formulation changes that affect the dissolution rate of a product are identified. The test is performed to ensure a drug complies with quality standards and specifications prior to release.

To learn more about our solutions for dissolution testing, click here.

Pion has developed a two-stage dissolution assay that simulates the transfer of a drug from stomach to intestine. This can reveal the influence of changing pH conditions on a drug’s behavior. Contact our analytical services team to schedule a consultation.

IVIVC stands for In Vitro-In Vivo Correlation. It is a scientific concept used in pharmaceutical research and development to establish a relationship between the in vitro drug release characteristics of a formulation and its in vivo pharmacokinetic behavior. IVIVC allows the prediction of drug behavior in the human body based on in vitro data, which can be helpful in drug formulation optimization and predicting drug performance under different physiological conditions. It is commonly used in drug development to support bioequivalence studies, define in vitro dissolution specifications, and guide drug formulation strategies.

Lipophilicity is the ability of a chemical compound to dissolve in or bind to fats and lipids. It is a measure of how readily a compound can pass through cell membranes and move through the body, as substances that are lipophilic tend to be absorbed more easily. Lipophilicity is an important factor in the pharmacokinetics and pharmacodynamics of drugs, as it can affect their distribution, metabolism, and overall effectiveness in the body.

‍

PBPK (Physiologically Based Pharmacokinetic) modeling is a mathematical modeling technique used in drug development to predict how a drug will be absorbed, distributed, metabolized, and excreted in the body. By incorporating detailed information about the physiology of different tissues and organs, as well as information about the drug compound itself, PBPK models can provide insights into how factors such as age, gender, disease state, and drug-drug interactions may affect drug exposure and response in different patient populations.

PBPK modeling is used to make informed decisions during drug development, such as optimizing dosing regimens, predicting drug-drug interactions, and assessing the potential for adverse effects. By integrating data from preclinical studies, clinical trials, and in vitro experiments, PBPK models can help researchers and clinicians better understand how a drug behaves in the body and how it may perform in different patient populations. Overall, PBPK modeling is a valuable tool for improving the efficiency and safety of drug development.

Physicochemical analysis is instrumental in measuring the ability of a chemical compound to produce a pharmacological effect. By examining the interactions between a drug and a biomolecule, researchers can assess whether the drug is delivering its intended effects or further improvements are required. Physicochemical analysis of drugs offers a faster way to acquire essential data and facilitate pharmaceutical development.

Learn more about our solutions here.

A high-pressure homogenizer is a piece of equipment used in various industries to break down particles to a smaller and more uniform size in a liquid or semi-solid mixture. This process involves forcing the product through a small orifice at high pressure, usually using a piston pump or an impact valve. This creates intense mechanical forces that disrupt the particles and reduce their size, resulting in a more stable and consistent product. High-pressure homogenizers are commonly used in the food, pharmaceutical, and cosmetic industries for applications such as emulsification, dispersion, and cell disruption. Pion now offers BEE brand high-pressure homogenizers.

‍

Drug flux can be described by Fick's Law, which states that the flux (J) is proportional to the concentration gradient across the membrane and the effective permeability (P_e) of the drug through the membrane.

J=P_e (c_d-c_a)

where c_d = donor concentration and c_a = acceptor concentration.

Essentially, the greater the concentration gradient and/or the higher the membrane permeability, the higher the drug flux and the total amount of drug that can be absorbed.

Oral absorption is the process by which a drug is absorbed into the bloodstream after oral administration (ingestion). The drug must pass through various barriers, including the gastrointestinal (GI) tract and intestinal membranes, to reach systemic circulation. Hence, the ability of the drug to permeate biological membranes is crucial as well as the concentration as a drug must dissolve in the gastrointestinal fluids to be absorbed.

Formulation development is a critical phase in product development. During this multi-step process, the active drug is characterized and combined with other chemical substances to produce a final, marketable pharmaceutical product.

Formulation development involves a variety of activities. It covers analytical assay development and characterization, particle sizing, and dosage form development. In addition, researchers assess the drug’s disintegration characteristics and measure its absorption potential.

Pharmaceutical formulation can influence the life cycle, patentability, and overall success of the drug. Many companies outsource pharmaceutical analysis to save time and ensure no issues or procedures are overlooked.

Learn more about our solutions for the pharmaceutical industry here.

In vivo imaging is a non-invasive technique used to peer deep into the internal systems of living organisms for diagnostic or research processes. By using special analytical instruments, researchers can analyze complex biological processes in plants, animals, or humans.

In vitro imaging can provide valuable insights for preclinical studies. From improving treatment response to assessing product safety, In vitro make the process of bringing a new pharmaceutical drug to the market faster and easier.

Learn about our imaging systems here.

Physchem characterization refers to the process of studying and analyzing the physical and chemical characteristics of a substance or material. This may involve identifying properties such as molecular structure, composition, purity, crystallinity, solubility, thermal stability, and other factors that can impact its behavior and performance. Various analytical techniques such as spectroscopy, microscopy, chromatography, and thermal analysis may be used in physchem characterization to gain a better understanding of the material in question. This information is important in various fields such as material science, pharmaceuticals, environmental science, and more.

It is recommended to develop an experimentation strategy that focuses on optimizing process pressure and flow pattern. For example, run your product through the system under varying operating pressures, perhaps 20k/30k/45kpsi, in Reverse Flow. Then, switch Parallel Flow and run the same three process pressures. This will leave you with six test samples, all processed under different pressures and homogenization forces. Analyze your results and use that as a roadmap to further optimize your parameters with more passes, different EC setups, or back pressure.

Dissolution is the process where a solute in a gaseous, liquid, or solid phase dissolves in a solvent to form a solution. Solubility is the maximum concentration of a solute that can dissolve in a solvent at a given temperature.

The Nano DeBEE has a minimum sample volume of 12 ml to return 5 ml of output material. The remainder can be collected by running water or buffer through the system once the inlet reservoir is empty of product.

A high pressure homogenizer allows a manufacturer to breakdown droplets and particles to sizes below one micron thus effecting homogenization. The DeBEE technology, which produces the highest intensity of processing energy, generates intense forces to breakdown droplets and particles to nanometers sizes. These extraordinary results deliver small and more uniform particles after only one pass through our system.

There’s no exact centipoise of viscosity that BEE systems are limited to because other characteristics such as particle size come into play. Generally speaking our systems can work up to 70000 cP with feed pressure or pressurized reservoirs. The Dual Feed option is a beneficial tool for feeding extremely viscous sample after the nozzle and is only available on BEE systems.

Pion Inc. is dedicated to provide the best service and support in the industry today. Factory trained technicians travel on-site to provide start up assistance, product training and technical support during the commissioning process. Annual maintenance agreements are available from the factory to provide a comprehensive preventative maintenance program to maintain, and inspect all system operations and functionality.

Precise Results

In vitro testing and imaging tools can accelerate your research by delivering swift, precise, and cost-effective results.

Analytical Services

Organizations rely on us for accurate tests, assays, analysis, and interpretation needed throughout the drug development process.

Reduced Errors

By using Pion equipment, problems with dissolution, solubility, permeability, and absorption can be detected earlier, saving valuable time and resources.

Learn about our solutions here.