News. Pharma & Biotech. Precise Capsule Filling with Gravimetric Dosing. Analytical solutions in the laboratory

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1 Pharma & Biotech Analytical solutions in the laboratory 11 News Precise Capsule Filling with Gravimetric Dosing Capsule filling is a critical step in API formulation design. Dosing the expensive and rare powdered substances must be precise as well as efficient. CoreRx, a contract R&D laboratory, delivers innovation with the support of Quantos dosing units to ensure sample-to-sample repeatability within tight deadlines. In 2006, Brian McMillan, Jim Davis, Rob Trivedi, Mark Licarde and Todd Daviau recognized an increasing need for API formulation design and delivery support for early phase pharma research. The group answered with a wellsuited prescription, CoreRx, a company to help pharmaceutical and biotechnology partners take molecules-to-market. Located in Clearwater, Florida, CoreRx is a contract R&D laboratory specializing in pharmaceutical formulation design and an industry leader in multilayer and combination therapies. Finding the right dosing solution In order to grow capabilities, CoreRx invested in an instrument for capsule filling. The team experienced technical challenges with the unit, halting production for months and costing them a project. While metrologist, Ted Gensel, sought a replacement, technicians filled capsules by hand, an economically unsustainable process. Ted turned to METTLER TOLEDO sales consultant, Lauren Wolfe. She demonstrated how they could substantially increase their capsule fill rate with a dosing tolerance of 1 percent with a Quantos automatic powder dispenser from MET- TLER TOLEDO. Quantos dispenses the right amount of powder automatically to prepare a solution. Gravimetric sample preparation ensures the highest level of reproducibility and errors are reduced by up to 60%.

2 Gravimetric Powder Dosing CoreRx developes drug formulations with automatic and manual gravimetric powder dosing systems Time-savings with automatic capsule filling According to Mark Licarde, VP of Operations, The first project we used Quantos on, we filled over 60 capsules per hour for a total of 480 capsules per shift. That s 5 times more efficient than with the manual process. Compared to CoreRx s first capsule filling unit, Quantos is a fraction of the cost and size, easy to use and can be serviced in-house. Matt Greene, CoreRx Formulation Scientist, particularly appreciates Quantos sample-to-sample traceability. CoreRx also uses the Quantos Handheld Powder Dispensing (HPD) unit as a new portable, safe and fully contained way to handle APIs in their labs. According to Matt Greene, many customers start a project with only a few grams of API, which needs to be handled with care. The HPD enables the formulation experts to make single analytical samples creating seamless technology transfer and scale-up. Today, CoreRx responds to customers rigorous requirements and deadlines by combining innovative thinking with the Quantos automated dosing system to deliver timely and cost competitive solutions. Text: Lauren Eiter NorAm Balance Product Manager Publisher Mettler-Toledo GmbH Laboratory Division Im Langacher CH-8606 Greifensee, Switzerland Production LAB Division Marketing Global MarCom Switzerland Subject to technical changes. Mettler-Toledo GmbH 01/16 Printed in Switzerland. 2 METTLER TOLEDO Pharma & Biotech News 11

3 Practical Guide for Optimized Titration Workflows Automating titrations enhances sample preparation, operational safety, efficiency and compliance. METTLER TOLEDO s new Titration Automation Guide supports workflow optimization through automation. Different laboratories pursue workflow automation for different reasons. Some seek improvements in efficiency; others seek to ensure operator-independent results. Compliance with regulations is also a common targeted objective. The benefits of automating titration workflows are clearly seen in all these aforementioned aspects. A guide to optimize titration workflows Get a detailed overview and advice on how processes can be enhanced by automating titration workflows with our new Titration Automation Guide. The guide offers helpful tips on how to create methods in line with Standard Operation Procedures and selected automation solutions, including: InMotion Autosampler for efficient and automated sampling handling. SmartSample for secure sample data transfer. SmartCodes for automated method assignment. Liquid Handler for versatile automated dosing. Download the Titration Automation Guide and optimize your workflow with METTLER TOLEDO today. Text: Lorenzo Cauzzi Titration Product Manager METTLER TOLEDO Pharma & Biotech News 11 3

4 Reaction Analysis Innovative Techniques to Synthesize Breakthrough Molecules Due to the increase in molecule complexity, shorter timelines and high scale-up confidence required by industry, new techniques are necessary to develop better chemistry. EasyMax synthesis workstations provide a simple and repeatable way to control reaction parameters 24 hours a day. Many chemists and engineers are constrained at the bench when exploring a wide range of experimental conditions. Due to inherent shortcomings associated with traditional equipment, the ability to discover new synthetic pathways in a timely manner is highly limited. The main challenges are: 1. Reaction temperature, a critical parameter, cannot be truly investigated with traditional synthesis equipment. 2. Expanding experimental evaluations to other critical process parameters, such as dosing rate, stirring and ph. 3. The requirement to record key process and performance data electronically and synchronize it with other analytical measurements for historical or regulatory purposes. Traditional equipment to support chemical synthesis, such as heating mantles, ice baths and cryostats combined with standalone dosing funnels and stirrer motors have limited temperature range, poor control capabilities, are 4 METTLER TOLEDO Pharma & Biotech News 11

5 Whitepaper: Techniques to Synthesize Breakthrough Molecules Read how four leading pharmaceutical companies implement new synthesis techniques and the impact on the chemical synthesis lab performance. Download the whitepaper now EasyMax 102 controls reactions 24/7 Automatic data management With a synthesis workstation, all experimental data gets captured and automanually intensive and do not easily (automatically/electronically) capture and report real-time data as the synthesis proceeds. Today, researchers are applying and enabling effective technology solutions to expand the research and development of innovative molecules. Synthesis workstation technologies open new possibilities for the control, optimization and reporting of critical process conditions. Tailored reaction temperature Traditionally, synthesis design space has been limited to three operating temperatures below room temperature: 0 C, -10 C and -78 C. In reality, many reactions operate in a more desirable manner when they are run at temperatures other than these historic conditions. With EasyMax synthesis workstations, chemists have control and can explore innovative reaction conditions by simply operating at the temperatures best suited for their chemistry. Expanded experimental evaluations Screening a range of process parameters (e.g. ph, dosing, etc.) during an experiment ensures that results are more reproducible, enables comparison between experiments with less repetition and scale up has a higher probability of success. EasyMax synthesis workstations provide 24-hour unattended safe and repeatable control of dosing, temperature and mixing parameters. matically shared. Fellow researchers can overlay batch results in a shared software platform for powerful data analysis and reporting. Simple and repeatable parameter control Due to the increase in molecule complexity, shorter timelines and the high scale up confidence required by industry, new techniques are necessary to develop better chemistry. EasyMax synthesis workstations provide a simple and repeatable way to control reaction parameters 24 hours a day ensuring that the chemist can remain focused on improving chemistry. Text: Francis Van Der Eycken, AutoChem Innovation Head METTLER TOLEDO Pharma & Biotech News 11 5

6 Pipetting Precise Liquid Handling in Biologic Drug Development Liquid handling is a very sensitive part of drug development. Since sample volumes are very low and certain experiments deal with biological molecules, selecting the right pipette for each experiment can determine its efficiency and accuracy. A pharmaceutical scientist shares her experience using Rainin pipettes in her research. Prior to drug marketing, pharmaceutical companies invest time and resources into developing drug candidates, which are screened for efficacy. Initially, efficacy is tested using cellular and molecular in vitro systems and, if a promising drug candidate is found, it will be further analyzed and refined until drug candidates with higher potency and specificity are developed. When developing biologic drug candidates, it is important to minimize the freeze/thaw cycles since it can have a negative effect on the molecules activity and even denature it. To achieve this, scientists will often aliquot multiple amounts of the same sample into separate vials to reduce the number of freeze/ thaw cycles master mix of samples goes through. The right pipette for sensitive experiments A scientist at a major pharmaceutical company, specializing in creating in vitro systems and drug candidates, noticed that aliquoting samples into microfuge and 15 ml plastic centrifuge tubes was made easier using Rainin Autorep E repeating dispenser with 50 ml Encode syringes. Flexible volume ranges and a wide selection of quick-change positivedisplacement syringe tips ensure precise performance on any aliquot volume from 1 μl 50 ml. Using the repeater allows her to fill microfuge and large plastic tubes quickly prior to moving these samples to the -80 C freezer. As her drug candidates are biological molecules, she needs to do nucleic acid work that requires cloning and sub-cloning workflows. Rainin Pipet-Lite XLS+, and LTS tips are the perfect tool for this job as her enzymatic reaction sizes are greater than the volume of wells in a 96-well plate. The sealing system on XLS+ pipettes delivers a plunger stroke that is smooth and precise, which is highly appreciated for this application. 6 METTLER TOLEDO Pharma & Biotech News 11

7 However, when she carries out work with sub-100 μl volumes, such as testing biological drug candidates for chemical composition and contaminants in parallel, the assays are most conveniently carried out using Rainin 8-channel Pipet-Lite XLS+ pipettes. The new push bar design integrated into all XLS+ multichannel pipettes ensures even and consistent aspiration and dispensing across all channels. The road to drug marketing Finally, successful drug candidates are then analyzed in animals. If there are no negative effects, the drug is tested on human beings in closely monitored clinical trials. If these trials support predefined successful endpoints, then the drug can be marketed to the public. The road to drug marketing is a long one, involving many steps where precise and repeatable liquid handling is critical to the success of the experiments. Rainin s portfolio of state-of-the-art pipettes and tips offers solutions to support the most challenging R&D work in pharma laboratories. Text: Rishi Porecha Rainin Application Specialist METTLER TOLEDO Pharma & Biotech News 11 7

8 UV/ VIS Spectroscopy Speed Up Your UV/VIS Measurements Accurate Results within Seconds The new series of UV/VIS spectrophotometers from METTLER TOLEDO combines state-of-the-art optical technology with intuitive One Click user interface in a compact design to deliver accurate results within seconds. It is the ideal partner for optimizing your spectroscopic workflows and data management tasks to meet regulatory guidelines. Increased efficiency FastTrack technology enables instant instrument readiness and full spectrum scans within a second without jeopardizing accuracy. Reliable results FastTrack technology has been designed to meet your expectations regarding instrument performance. Be at ease that you get results you can trust. Simple operation Easy to learn and customizable to each user s needs the intuitive user interface guides you step by step and lets you start applications with only OneClick.

9 Automated performance verification Compliance with regulations has never been easier. CertiRef automatically verifies all performance parameters and generates a comprehensive report. Methods library Pre-defined METTLER TOLEDO methods are available and ready for use, or for adaptation to your specific application needs. Plug & Play accessories Select the right accessory for every application, from various sample holders to automation devices for increased operation performance. Compliant with LabX The LabX PC software offers sophisticated tools for data retrieval and management, graphical analysis of spectra and includes full regulatory support. ABC of UV/VIS Spectroscopy Guide A comprehensive 360 overview about UV/VIS theory, instrument technology and industry segment specific applications. A valuable guide to enlighten your view on UV/VIS spectroscopy.

10 Product Highlight Modular Titration Excellence Tailored to Your Needs The new generation of Titration Excellence builds upon the proven modular concept broadening the analyses offering with automated sodium analysis and coulometric Karl Fischer titration. Titration Excellence speeds up routine analyses by automating data transfer and making operation more intuitive thanks to the high-resolution touch screen. Start analyses with just OneClick and have confidence in your analytical results. Efficient data transfer A SmartSample reader is now a standard feature on all Excellence titrators. Wireless data transfer from balance to titrator on single and multiple titrations eliminates transcription errors. Secure routine operation StatusLight, the interplay of light and sound, supports routine operation with visual and acoustic signaling. Stay in touch with your titration from anywhere in the lab! Karl Fischer modularity Perform coulometric KF titration on all Titration Excellence instruments. The new coulometric module improves Bromine Index determination and requires no extra bench space. 10 METTLER TOLEDO Pharma & Biotech News 11

11 Unattended, Representative Sampling Even in Extreme Conditions Sampling chemical reactions for offline analysis is standard practice. However, the sampling process is not always a precise operation and can be challenging with reactions at elevated temperatures or reactions where slurry exists. EasySampler 1210 was designed to eliminate these challenges with its automated and robust inline method of taking representative samples from reactions, even in extreme conditions. Representative samples The patented probe enables the capture and immediate quenching of reaction samples. This is particularly advantageous for monitoring low temperature and air sensitive chemistry. Unattended 24/7 Samples are taken, quenched, diluted to a user-specified concentration and transferred to vials all at the simple the touch of a button. Sample sequencing can be programmed for unattended reaction sampling. Heterogeneous reactions EasySampler captures reaction samples, including the solids, into a pocket of fixed volume. Solids dissolution begins immediately, delivering a dissolved sample for precise and accurate analytical data. easysampler METTLER TOLEDO Pharma & Biotech News 11 11

12 METTLER TOLEDO Service Effective Right Away with METTLER TOLEDO Service Take the stress-free route to instantly meet your productivity, quality and regulatory requirements. Rely on METTLER TOLEDO s trained experts when it comes to professional installation and operator instructions. METTLER TOLEDO Service offers competence and expertise in the following four areas: Installation Pacs Professional installation and configuration User familiarization Equipment qualification Calibration and Certificates Easily understandable and audit-proof certificates Internationally approved procedures Selected according to your requirements User Training Tailored to your needs Trained by the expert of the manufacturer Extended Care Extended warranty Preventive maintenance Priority technical assistance Mettler-Toledo GmbH Laboratory Division Im Langacher CH-8606 Greifensee, Switzerland For more information Local contact: