Precise Capsule Filling with Gravimetric Dosing...and report real-time data as the synthesis...

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In 2006, Brian McMillan, Jim Davis, Rob Trivedi, Mark Licarde and Todd Daviau recognized an increasing need for API formulation design and deliv-ery support for early phase pharma re-search. The group answered with a well-suited prescription, CoreRx, a company to help pharmaceutical and biotechnol-ogy partners take molecules-to-market. Located in Clearwater, Florida, CoreRx is a contract R&D laboratory special-izing in pharmaceutical formulation design and an industry leader in multi-layer and combination therapies.

Finding the right dosing solutionIn order to grow capabilities, CoreRx invested in an instrument for capsule filling. The team experienced technical challenges with the unit, halting pro-

duction for months and costing them a project. While metrologist, Ted Gensel, sought a replacement, technicians filled capsules by hand, an economically un-sustainable process. Ted turned to METTLER TOLEDO sales consultant, Lauren Wolfe. She demon-strated how they could substantially in-crease their capsule fill rate with a dos-ing tolerance of 1 percent with a Quantos automatic powder dispenser from MET-TLER TOLEDO. Quantos dispenses the right amount of powder automati-cally to prepare a solution. Gravimetric sample preparation ensures the highest level of reproducibility and errors are reduced by up to 60% .

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 re-

peatability within tight deadlines.

Precise Capsule Fillingwith Gravimetric Dosing

11Pharma & Biotech

Analytical solutions in the laboratory

2 METTLER TOLEDO Pharma & Biotech News 11

www.mt.com/quantos

Publisher Mettler-Toledo GmbH Laboratory Division Im Langacher CH-8606 Greifensee, Switzerland

Production LAB Division MarketingGlobal MarCom Switzerlandwww.mt.com/lab-segmentnews

Subject to technical changes. © Mettler-Toledo GmbH 01/16 Printed in Switzerland.

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Time-savings with automatic capsule filling According to Mark Licarde, VP of Opera-tions, “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 man-ual 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, Cor-eRx 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 creat-

ing 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 solu-tions.

Text: Lauren EiterNorAm Balance Product Manager

CoreRx developes drug formulations with automatic and manual gravimetric powder dosing systems

3METTLER TOLEDO Pharma & Biotech News 11

www.mt.com/titration-automation-guide

Different laboratories pursue workflow automation for different reasons. Some seek improvements in efficiency; oth-ers seek to ensure operator-independent results. Compliance with regulations is also a common targeted objective. The benefits of automating titration work-flows are clearly seen in all these afore-mentioned aspects.

A guide to optimize titration workflows Get a detailed overview and advice on how processes can be enhanced by au-tomating titration workflows with our new ‘Titration Automation Guide’. The guide offers helpful tips on how to create methods in line with Standard Operation

Automating titrations enhances sample preparation, operational safety,

efficiency and compliance. METTLER TOLEDO’s new Titration Automation

Guide supports workflow optimization through automation.

Practical Guidefor Optimized Titration Workflows

Procedures and selected automation so-lutions, 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 CauzziTitration Product Manager


Innovative Techniquesto Synthesize Breakthrough Molecules

Due to the increase in molecule complexity, shorter timelines and high scale-up confi-

dence 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 con-strained 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 inves-tigated 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 pro-cess and performance data electroni-cally and synchronize it with other analytical measurements for histori-cal 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

Reac

tion

Anal

ysis


EasyMax 102 controls reactions 24/7

Whitepaper: Techniques to Synthesize Breakthrough MoleculesRead how four leading pharmaceutical companies implement new synthesis techniques and the impact on the chemical synthesis lab performance.

Download the whitepaper now www.mt.com/Synthesis-Techniques

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 complex-ity, shorter timelines and the high scale up confidence required by industry, new techniques are necessary to develop bet-ter chemistry. EasyMax synthesis worksta-tions provide a simple and repeatable way to control reaction parameters 24 hours a day ensuring that the chemist can remain focused on improving chemistry.

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 experi-ment ensures that results are more re-producible, 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 mix-ing parameters.

Automatic data management With a synthesis workstation, all ex-perimental data gets captured and auto-

manually 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

Text: Francis Van Der Eycken, AutoChem Innovation Head

www.mt.com/EasyMax


Pipe

tting

Precise Liquid Handlingin Biologic Drug Development

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 ana-lyzed and refined until drug candidates with higher potency and specificity are developed.

When developing biologic drug candi-dates, it is important to minimize the freeze/thaw cycles since it can have a negative effect on the molecules’ activ-ity and even denature it. To achieve this, scientists will often aliquot multiple

amounts of the same sample into sepa-rate vials to reduce the number of freeze/thaw cycles master mix of samples goes through.

The right pipette for sensitive experimentsA scientist at a major pharmaceutical company, specializing in creating in vi-tro systems and drug candidates, noticed that aliquoting samples into microfuge and 15 mL plastic centrifuge tubes was made easier using Rainin Autorep E re-peating dispenser with 50 mL Encode syringes. Flexible volume ranges and a wide selection of quick-change positive-displacement syringe tips ensure precise

Liquid handling is a very sensitive part of drug development. Since

sample volumes are very low and certain experiments deal with biolog-

ical molecules, selecting the right pipette for each experiment can de-

termine its efficiency and accuracy. A pharmaceutical scientist shares

her experience using Rainin pipettes in her research.

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 sam-ples to the -80 °C freezer.

As her drug candidates are biological molecules, she needs to do nucleic acid work that requires cloning and sub-clon-ing 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.


However, when she carries out work with sub-100 μL volumes, such as testing biological drug candidates for chemical composition and contaminants in par-allel, the assays are most conveniently carried out using Rainin 8-channel Pipet-Lite XLS+ pipettes. The new push bar design integrated into all XLS+ mul-tichannel pipettes ensures even and con-sistent aspiration and dispensing across all channels.

The road to drug marketingFinally, successful drug candidates are then analyzed in animals. If there are no negative effects, the drug is tested on hu-man 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. Rain-in’s portfolio of state-of-the-art pipettes and tips offers solutions to support the most challenging R&D work in pharmalaboratories.

Text: Rishi PorechaRainin Application Specialist

www.mt.com/rainin

UV/V

IS S

pect

rosc

opy Speed Up Your UV/VIS Measurements

Accurate Results within Seconds

The new series of UV/VIS spectrophotometers from METTLER TOLEDO com-bines state-of-the-art optical technology with intuitive One Click™ user in-terface in a compact design to deliver accurate results within seconds. Itis the ideal partner for optimizing your spectroscopic workflows and datamanagement 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™.

Speed Up Your UV/VIS Measurements Accurate Results within Seconds

Plug & Play accessories

Select the right accessory for every application, from various sample holders to automation devices forincreased operation performance.

Methods library

Pre-defined METTLER TOLEDO methods are available and ready for use, or for adaptation to your specific application needs.

Automated performance verification

Compliance with regulations has never been easier. CertiRef™ automatically verifies all performance parameters and generates a comprehensive report.

Compliant with LabX®

The LabX PC software offers sophisti-cated tools for data retrieval and man-agement, graphical analysis of spectraand includes full regulatory support.

ABC of UV/VIS Spectroscopy Guide

A comprehensive 360° overview about UV/VIS theory, instrument technology and industry segment specific applica-tions. A valuable guide to enlighten your view on UV/VIS spectroscopy.

www.mt.com/sn-uvvis


Prod

uct H

ighl

ight Modular Titration Excellence

Tailored to Your Needs

www.mt.com/titration

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.

Karl Fischer modularityPerform coulometric KF titration on all Titration Excellence instruments. The new coulometric module improves Bromine Index determination and re-quires no extra bench space.

Secure routine operationStatusLight™, the interplay of light and sound, supports routine operation with visual and acoustic signaling. Stay in touch with your titration from any-where in the lab!

Efficient data transferA SmartSample reader is now a stan-dard feature on all Excellence titrators. Wireless data transfer from balance to titrator on single and multiple titra-tions eliminates transcription errors.


Representative samplesThe patented probe enables the capture and immediate quenching of reaction samples. This is particularly advanta-geous for monitoring low temperature and air sensitive chemistry.

Unattended, Representative SamplingEven 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.

Heterogeneous reactionsEasySampler captures reaction sam-ples, including the solids, into a pock-et of fixed volume. Solids dissolution begins immediately, delivering a dis-solved sample for precise and accurate analytical data.

Unattended 24/7Samples 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 re-action sampling.

www.mt.com/ easysampler

www.mt.comFor more information

Mettler-Toledo GmbHLaboratory DivisionIm LangacherCH-8606 Greifensee, Switzerland

Local contact: www.mt.com/contacts

Effective Right Awaywith METTLER TOLEDO Service

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 profes-sional installation and operator instructions.

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manufacturer

Extended Care• Extended warranty

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Precise Capsule Filling with Gravimetric Dosing...and report real-time data as the synthesis...

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