Unchained Labs (アンチェインドラブズ） List of Products and Services

Aunty is a protein stability analysis tool that boasts high speed and high throughput. Utilizing techniques such as fluorescence, static light scattering, and dynamic light scattering, Aunty rapidly conducts thermal denaturation and aggregation experiments. During thermal ramp experiments involving temperature changes, it can read samples across an entire 96-well plate. You can screen candidates, conditions, or formulations in large quantities and repeat experiments as many times as needed. Aunty outputs results with unprecedented data resolution, supporting you in finding the optimal samples at overwhelming speed. 【Features】 ■ Measures 8μL, up to 96 samples simultaneously in SBS format plates ■ Simultaneously measures fluorescence, static light scattering, and dynamic light scattering ■ Automation is also possible 【Application Examples】 ■ Melting temperature (Tm, Tonset) ■ Aggregation (Tagg, Tsize) ■ Colloidal stability (kD, B22, G22) ■ Long-term stability ■ Virus vector stability *For more details, please refer to the PDF materials or feel free to contact us.

• Other protein analysis

The development of lipid nanoparticles (LNPs) faces many challenges. The formulation, optimization, and scale-up for clinical trials are complex, costly, and a race against time. Our LNP solutions are designed to accelerate all steps of LNP synthesis and characterization. Sunscreen accelerates LNP formulation screening by reducing costs and time, generating up to 96 unique LNP formulations within 6 hours. Next, using Sunshine, you can develop, optimize, and scale up protocols with the appropriate formulations obtained from Sunscreen. When it comes to the clinical trial phase, Sunbather can accommodate LNP production in a GMP environment using the same processes and microfluidic chips (Sunny) utilized by Sunscreen and Sunshine. In this way, the Sun series allows for a seamless transition from screening formulation conditions to scale-up and GMP manufacturing, as they all use the same pumps and microchannel chips. *For product details, please download various materials.

• Other Physics and Chemistry Equipment

The transition from LNP to GMP is a costly and complicated process. Typically, this requires switching equipment, using different flow paths and mixing devices, and essentially re-developing and re-validating everything that has been painstakingly done so far. With Sunbather, the transition to GMP can be done easily thanks to its recording features, interchangeable flow paths, and easily transferable design. Sunbather uses the same mixing process and protocols as the Sunscreen and Sunshine from the same Sun series, allowing for easy transition of adjusted formulation conditions to GMP. - Up to 1.8 L/h - Integrated inline dilution - Fully interchangeable flow paths - A wide variety of mixing devices - Software compliant with 21 CFR Part 11 - Process transferable from Sunshine

• Other Physics and Chemistry Equipment

The concentration of lipid nanoparticles is an important parameter that should be known for all batches of particles, but existing methods either cannot handle throughput, require dilutions that affect accuracy, or take a lot of time. Additionally, keeping the particles at the appropriate size is a goal for everyone, but it is not possible to detect all aggregates in the sample, and just collecting size data for all samples is quite challenging. In this webinar, you will learn how our newly updated Stunner can not only determine the size of LNPs and quantify particle concentration but also quantify payloads, providing unique information from various nanoparticle applications. *This webinar content was translated into Japanese and presented in Japanese by Nelis Denys, M.Sc., Market Manager at Unchained Labs, Inc. ■ Public viewing period: Until March 27, 2024 (Wednesday) ■ For details and viewing, click here >> https://go.unchainedlabs.com/l/907652/2024-03-04/xzbwj

• Other protein analysis

Researchers of lipid nanoparticles (LNPs) spend a tremendous amount of time on screening, optimization, and scaling up experiments to achieve optimal performance, spot-on targeting, and controlled release of active pharmaceutical ingredients (APIs). Factors such as solubility, pH stability, payload release, and encapsulation all depend on particle size, shape, and structure. In other words, to obtain the right formulation, it is necessary to explore a vast number of formulation parameters and process parameters one by one, and even if a perfect formulation is found, scaling up usually means switching equipment and re-optimizing settings. In this webinar, we will introduce a platform, Sunny Suite, that can reduce the time spent on these LNP formulations. ■ Date and Time: February 26 (Monday) 14:00~ ■ Speaker: Yuji Senoo, Field Application Scientist, Unchained Labs, Inc. ■ Register here: https://unchainedlabs.zoom.us/webinar/register/3217065146675/WN_U1o3xQoZRAKHN-A-7b1yqg

• Other protein analysis

Once we succeed in finding the optimal formulation conditions for sunscreen, let's use Sunshine to adjust the size of the LNP. Furthermore, we will optimize the protocols and processes for scaling up. We will find the ideal flow rate and explore different mixing options. Next, we will adjust these to the appropriate dilution factor that can keep them stable. Once everything is in place, Sunshine will transition to continuous mode, allowing us to produce several dozen liters in a day. In other words, we will achieve process development and scaling up on a single platform. Many researchers have likely been looking forward to the birth of such a groundbreaking system. • 10 experiments in 15 minutes • Fraction & total flow • From 1 mL to continuous flow • Flow rate 0.1 to 30 mL/min • Reusable microfluidic chips • Possible transition of protocols from sunscreen

• Other Physics and Chemistry Equipment

To create the optimal LNP, it takes a tremendous amount of time and effort to examine and pursue formulation conditions. LNPs are nanoparticles composed of multiple lipids. Therefore, it is necessary to find the optimal conditions such as the mixing ratios, the ratio of lipids to payload, and the flow rates during mixing. Furthermore, we must also consider throughput issues. Sunscreen can produce up to 96 types of small LNPs within six hours, thus solving the previous throughput problems. This means that it is possible to explore a greater number of formulation condition investigations in a single day. • Fully automated execution of up to 96 types of condition investigations within six hours • 200 μL to 2 mL per experiment • Flow rate of 0.1 to 30 mL/min • Reusable microfluidic chips • Seamless scale-up through process and protocol optimization

• Other Physics and Chemistry Equipment

In the development of vectors such as LNP (lipid nanoparticles) and AAV (adeno-associated virus), buffer exchange is an important step and presents various challenges. LNP requires rapid exchange, while AAV necessitates improvements in recovery rates and concentration, so a single solution is not always optimal. Unagi is a buffer exchange and concentration device developed to accommodate biomolecules for biological formulations and gene therapies, utilizing pressure-based ultrafiltration/diafiltration (UF/DF) technology. It achieves precise buffer exchange and concentration without reducing sample recovery rates. In this webinar, you will see the final exchange values, concentration values, and analytical characteristics under various conditions for LNP and AAV. ■ Date and Time: October 30 (Monday) 14:00~ ■ Speaker: Yuji Senoo, Field Application Scientist, Unchained Labs Inc. ■ Register here: https://unchainedlabs.zoom.us/webinar/register/5816780852848/WN_WfFOAUgtQGCq0tamdhQjWg

• Other protein analysis

The evaluation of viral stability necessary for the development of gene therapy using adeno-associated virus (AAV) vectors is very complex and requires an understanding of the properties of all viral particles, viral genomes, and capsid proteins. Analyzing the effects on stability necessitates the assessment of serotype, formulation, manufacturing process, and storage conditions, while these analyses have been time-consuming and labor-intensive. Uncle combines three measurement modes: fluorescence, SLS, and DLS, allowing for insights necessary for the analysis of capsids, proteins, and nucleic acids all in one device. By using Uncle, a sample volume of just 9μL can analyze up to 48 samples in under 2 hours, enabling a quicker evaluation of more drug candidates and formulations. 【Features】 ■ Batch measurement of 9μL, up to 48 samples in approximately 2 hours at the shortest 【Applications】 ■ Tm & Tagg ■ Tm by SYPRO DSF ■ Isothermal stability ■ Sizing and polydispersity ■ Sizing by thermal gradient ■ Refolding measurement ■ Viscosity ■ kD ■ B22 ■ G22 ■ ΔG ■ Stability of viral capsids

• Other protein analysis

ADC (Antibody-Drug Conjugate) is a biopharmaceutical that is attracting attention due to its pharmacological activity and the excellent specificity of antibodies. However, the characterization of ADCs is very challenging due to the rarity of samples and their tendency to aggregate. In this webinar, we will explain how to obtain important information such as the concentration, labeling, stability, and viscosity of mAbs and their conjugates from just a few microliters of sample, along with actual data to demonstrate the evaluation of ADC characteristics. ■ Date and Time: June 16 (Friday) 14:00~ ■ Speaker: Yukinori Ooshiro, Field Application Scientist, Unchained Labs, Inc. ■ Register here: https://unchainedlabs.zoom.us/webinar/register/5816780852848/WN__LZqwPKFTvy2KTYnajByqg

• Other protein analysis

"Leprechaun" is a system that analyzes whether lentivirus particles are of the correct size and structure, and can measure viral titer. It allows for the determination of the titer of lentivirus present in a sample without being misled by confusing noise (such as incomplete viruses or contamination). Not only can it measure information that was previously only obtainable separately through conventional methods like ELISA, qPCR, and transduction assays, but it also enables structural analysis that those methods could not provide, all on a single platform. Capabilities: ■ Lentivirus titer ■ Lentivirus structure ■ Exosome concentration ■ Analysis of contamination (impurities such as extracellular vesicles) Features: ■ No sample purification required ■ Physical structural analysis possible ■ Distinction between virus integrity and impurities ■ Up to 16 samples can be measured at once *For more details, please refer to the PDF document or feel free to contact us.

• Other measurement and measuring equipment

The development of biopharmaceuticals is becoming mainstream, but compared to small molecule drugs, many challenges remain due to their complex structures and properties. For example, long-term stability tests when researching protein stability in biopharmaceuticals are generally conducted in the later stages of development. However, this approach carries the risk that issues with candidate drugs may only become apparent in the latter half of development. Additionally, controlling the viscosity of formulations is one of the important development requirements, yet obtaining viscosity data can take too long, which is also a challenge. In this webinar, we will tackle these challenges in biopharmaceutical development and introduce methods for conducting isothermal stability tests early in the development process, as well as a way to simultaneously measure the viscosity of multiple samples in just a few minutes without the need for cleaning. ■ Date and Time: May 22 (Monday) 14:00~ ■ Speaker: Yukinori Ooshiro, Field Application Scientist, Unchained Labs Inc. ■ Register here: https://unchainedlabs.zoom.us/webinar/register/5816780852848/WN_lsAhytF6R-ayPZLDougO3w

• Other protein analysis

Subject: In recent years, viruses have been widely used as modalities for gene therapy and vaccines, and research and development have been advancing. Adenoviruses are one of the representative viruses, but traditional evaluation methods are diverse and require a lot of time and effort. In this seminar, we will explain how Stunner can quickly and accurately resolve issues such as capsid titer, Full/Empty ratio, and the presence or absence of aggregation as a one-stop solution. We will also look at the application of adenovirus vector sample QC and the evaluation of various types of adenoviruses. ■ Date and Time: April 25 (Tuesday) 14:00~ ■ Speaker: Yukinori Ooshiro, Field Application Scientist, Unchained Labs, Inc. ■ Registration link: https://unchainedlabs.zoom.us/webinar/register/5816780852848/WN_OJ0mgL39TZiB_kUC3sojmw

• Other protein analysis

Lipid nanoparticles (LNPs) are currently one of the most notable delivery systems used in mRNA vaccines, gene therapy, cancer treatment, and more. However, their development requires a complex process involving formulation screening, control of size and quality, removal of organic solvents, and characterization, which demands significant effort and time. In this webinar, we will introduce methods to enhance the production of perfectly sized LNPs, evaluate their size and quality characteristics, perform buffer exchange and sample concentration, and analyze stability at each step of the development process workflow. ■ Date and Time: March 27 (Monday) 14:00~ ■ Speaker: Yukinori Ooshiro, Field Application Scientist at Unchained Labs ■ Register here: https://unchainedlabs.zoom.us/webinar/register/5816780852848/WN_ycxoqBXnScOgpzBx1dQ16g

• Other protein analysis

AAV production, infectivity, Full/Empty ratio, and optimization of introduced genes require a lot of time. Additionally, during the formulation screening stage, many conditions need to be examined, such as different pH levels, salt concentrations, or additives. Our Unagi enables rapid and quantitative buffer exchange and concentration by pressurizing the sample solution on a dialysis membrane, allowing for the examination of numerous formulation conditions for AAV samples at once. Furthermore, Stunner can accurately assess AAV titer, Full/Empty ratio, and aggregation evaluation by simultaneously measuring UV/Vis and DLS in a high-throughput manner. In this webinar, we will explain how to accurately and quickly conduct formulation considerations and physical property evaluations of AAV samples using our Stunner and Unagi. ■ Date and Time: February 21 (Tuesday) 14:00~ (approximately 40 minutes) ■ Speaker: Yukinori Ooshiro, Field Application Scientist, Unchained Labs, Inc. ■ Register here: http://bit.ly/3WU3IM9

• Other protein analysis

"Nunchuck" is a platform that combines two essential steps needed to create perfectly sized lipid nanoparticles (LNPs): total flow rate (TFR) screening and LNP formulation. In just 10 minutes, you can quickly find suitable conditions through 8-stage total flow rate screening, and then immediately proceed to produce LNPs ranging from 0.25 mL to 1 L. The software is very easy to use, allowing you to start production right away. Additionally, the physical property evaluation of the produced LNPs can be done conveniently and quickly with our Stunner. *For more details, please refer to the LNP application note available via the "PDF Download" button below. Stop the repetitive workflow that measures only one flow rate at a time, and try our LNP production method that completes everything in one go. 【Features】 - Production of LNPs sized 50 to 200 nm - 8-stage TFR screening in 10 minutes - Proven results from 0.25 mL to 1 L - Executed with a dedicated cartridge - Easy to use *For more details, please refer to the PDF materials or feel free to contact us.

• others

"Nunchuck" is a platform that combines two essential steps needed to create perfectly sized lipid nanoparticles (LNPs), namely, full-flow screening and LNP formulation. In just 10 minutes, it screens 8 stages of TFR to quickly find suitable conditions, and then immediately moves on to the production of LNPs ranging from 0.25 mL to 1 L. It is very easy to use, allowing even first-time users to start measurements right away. Stop the repetitive workflow that can only measure one flow at a time, and try the LNP production method that can be completed in one go. 【Features】 ■ LNP sizes of 50–200 nm ■ Screens 8 stages of TFR in 10 minutes ■ Proven results from 0.25 mL to 1 L ■ Executed with a dedicated cartridge ■ Easy to use *For more details, please refer to the PDF document or feel free to contact us.

• others

"Honeybun" is a high-speed viscometer that can output data almost simultaneously with processing. Regardless of whether the number of samples is 1 or 10, it uses a few microliters of each sample through a microchannel and reads viscosities in the range of 0.5-150 cP within a few minutes. No pre-treatment or cleanup of samples is necessary. 【Features】 ■ Can measure up to 10 samples at once ■ Required sample volume: 35μL (can measure from 15μL; see application notes) ■ Measurement completed in under 1 minute (for viscosities below 10 cP) ■ Measurement range: 0.5-150 cP ■ No cleaning required and maintenance-free *For more details, please refer to the PDF document or feel free to contact us.

• Other bio-related products

Viscosity data is essential for the formulation development, characterization, and quality control of biopharmaceuticals. In recent years, biopharmaceuticals have been increasingly concentrated, leading to rising viscosity as a challenge, and its importance is growing. However, most current viscosity measurement devices require large amounts of samples and extensive working hours, making it difficult to obtain sufficient viscosity data. In this seminar, we will review actual measurement results of antibodies and other proteins using the high-speed micro-volume viscometer, Honeybun, designed for biological formulations, and delve into its excellent precision, accuracy, and throughput from low-volume samples. ■ Date and Time: September 5 (Monday) 14:00~ (approximately 30 minutes) ■ Speaker: Yukinori Ooshiro, Field Application Scientist, Unchained Labs, Inc. ■ Register here: https://bit.ly/3AOGnUf

• Other protein analysis
• Viscometer
• Capillary Viscometer

We would like to introduce data using our stability assessment tool, Stunner, in the field of LNP, which is currently attracting attention. Speaker: Mr. Nelis Denys, Product Manager at Unchained Labs Here, you can watch webinars that we have held in the past. Please register using the link below (registration is one-time only, and you will have unlimited access to all videos, including this one). https://go.unchainedlabs.com/JPVideosForm

• Other protein analysis

We would like to introduce data using our stability evaluation tool, Stunner, in the currently trending AAV field. Speaker: Mr. Nelis Denys, Product Manager at Unchained Labs Here, you can watch webinars that have been held in the past. Please register using the link below (registration is one-time only, and you will have unlimited access to all videos, including this one). https://go.unchainedlabs.com/JPVideosForm

• Other protein analysis

In the development of biopharmaceuticals and gene therapies, a lot is required for the evaluation of their characteristics, but particularly the assessment of stability is very important. Stunner is a device equipped with both UV/Vis and DLS that enables quality evaluation of proteins, AAV, adenoviruses, and LNPs in a low-volume and high-throughput manner. Moreover, it not only allows for measurements in a short time but also boasts high precision as one of its strengths. **Features of Stunner** - Measures 2μL, up to 96 samples in a single batch in 60 minutes **Applications** - AAV and adenovirus capsid titer - AAV and adenovirus empty/full ratio - Lipid nanoparticle (LNP) payload amount - Aggregation measurement - Concentration measurement - Sizing & polydispersity - B22 & kD *Download related materials now to check the details!*

• Other Protein Research

Buffer exchange and concentration must be performed as a pre-treatment of the sample, which is a time-consuming task. This process takes a long time, and you have to be present the entire time. "UNAGI" is a fully hands-free benchtop buffer exchange solution designed to perform this tedious task for you. You can be anywhere during the process, eliminating the need to stay in the laboratory the whole time. 【Features】 ■ Simultaneous processing of up to 8 samples ■ Efficient solvent removal to prevent sample adsorption, achieving over 96% recovery rate ■ Built-in recipes for UF/DF buffer exchange ■ User-friendly software ■ Concentration of up to 8 diluted samples from 48mL to 8mL in one go *For more details, please refer to the PDF document or feel free to contact us.

• Other filtration and separation equipment
• Other Protein Research Software

Buffer exchange and concentration must be performed as a sample preprocessing step. This is a labor-intensive task that takes a long time, requiring your presence throughout the process. "UNAGI" is a fully hands-free benchtop buffer exchange solution designed to take over this tedious task. It can process up to 8 samples simultaneously. The software is very easy to operate, allowing you to be anywhere during the work, eliminating the need to stay in the laboratory the entire time. 【Features】 ■ Simultaneous processing of up to 8 samples ■ Efficient solvent removal prevents sample adsorption, achieving over 96% recovery rate ■ Built-in recipes for UF/DF buffer exchange ■ User-friendly software ■ Concentrates up to 8 diluted samples from 48mL to 8mL in one go *For more details, please refer to the PDF document or feel free to contact us.

• Other Protein Research Software
• DNA analysis

"BIGTUNA" is a high-throughput fully automated buffer exchange and concentration device that can automate buffer exchange with a setup time of just 30 minutes, accommodating a wide range of sample numbers and volumes. We offer two types of plate-based filters that can simultaneously exchange and concentrate 24 or 96 samples. With easy setup, you can have better control over your experiments and significantly reduce manual labor time. You can step away from the tedious task of buffer exchange and use the extra time for what you truly want to do. 【Features】 ■ Free yourself from manual buffer exchange ■ Accommodates a wide range of sample numbers and volumes ■ Processes at an optimal buffer exchange rate ■ Automatically concentrates from 48mL to 8mL ■ Easy condition settings *For more details, please refer to the PDF document or feel free to contact us.

• Other concentrating equipment

"JUNIOR" is a product that enables high-precision weighing and dispensing of various powders and solids. With its built-in tapping function, it allows for high-precision weighing of smaller amounts without particle size bias. Additionally, it uses adaptive learning algorithms to accurately distribute and measure various samples. 【Features】 ■ Compatible with various vial sizes, plates, capping, and complex sample transport ■ LEA software: Intuitive operation from the front end, automatically integrates analysis data ■ Supports complex sample transport ■ Compatible with vials and plates ■ Manages the condition of samples with images *For more details, please refer to the PDF document or feel free to contact us.

• Other balances and scales

"BIG KAHUNA" is a product capable of organic synthesis screening, catalyst screening, and the development of metal catalysts. The high-pressure reactor for reaction screening is suitable for high-throughput catalyst screening. You can use 48 or 96 vials. It can be utilized for reactions under moderate high-pressure conditions or under high-pressure and high-temperature conditions. 【Features】 - High-precision weighing and dispensing of various powders and solids - Accurate distribution and weighing of various samples using adaptive learning algorithms - A dedicated hopper with an integrated stirring wire enables suitable powder dispensing without particle size bias - The built-in tapping function allows for smaller, high-precision powder weighing without particle size bias *For more details, please refer to the PDF document or feel free to contact us.

• Other counters and measuring instruments

"Uncle" is a product that allows for the acquisition of more data with a small amount of protein. The required sample volume is only 9μL. By combining three different measurement modes—fluorescence, SLS, and DLS—it is easy to evaluate the optimal formulation and the stability of proteins or viral vectors. 【Features】 ■ Measure up to 48 samples in as little as about 2 hours with just 9μL. 【Applications】 ■ Tm & Tagg ■ Tm via SYPRO DSF ■ Isothermal stability ■ Sizing and polydispersity ■ Sizing via thermal gradient ■ Refolding measurements ■ Viscosity ■ kD ■ B22 ■ G22 ■ ΔG ■ Stability of viral capsids *For more details, please refer to the PDF document or feel free to contact us.

• Other protein analysis

"Stunner" is a product that allows simultaneous acquisition of UV/Vis concentration, dynamic light scattering (DLS), and static light scattering (SLS) data from a 2μL identical sample. It enables detailed investigation of AAV and adenoviruses to measure total capsid titer and Empty/Full ratios, as well as to obtain payload concentration and size data of lipid nanoparticles all at once. You can analyze concentration, hydrodynamic size, polydispersity, and the presence of aggregates collectively, allowing you to assess the quality of proteins. This way, you can immediately determine whether your AAV, adenoviruses, lipid nanoparticles, or proteins are suitable for your purposes. [Features] ■ Measure up to 96 samples in a batch in 60 minutes*/12 minutes** *When measured by DLS **When measured by UV/Vis only [Applications] ■ AAV/Adenovirus capsid titer ■ AAV/Adenovirus Empty/Full ratio ■ Lipid nanoparticle (LNP) payload amount ■ Aggregate measurement ■ Concentration measurement ■ Sizing & polydispersity ■ B22 & kD *For more details, please refer to the PDF document or feel free to contact us.

• Other protein analysis

"Lunatic" is a product that allows for easy simultaneous quantification of proteins, DNA, and RNA. The required sample volume is only 2μL, and up to 96 samples can be measured in 5 minutes. High-concentration samples can also be measured directly without dilution. 【Features】 ■ Measure 2μL, up to 96 samples in 5 minutes ■ Dynamic range coverage from 0.02 to 200 mg/mL* *for mAb ■ Outstanding accuracy and precision ■ Automation is also possible *For more details, please refer to the PDF document or feel free to contact us.

• Other protein analysis
• Analytical Equipment
• Other measurement and measuring equipment