AAPS Poster - #M1430-03-017 - Development of an LC-MS/MS Method for Quantification of Cytarabine in Rat Plasma.

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By Karen Pryor October 26, 2018

AAPS Poster - #M1430-03-017 - Development of an LC-MS/MS Method for Quantification of Cytarabine in Rat Plasma - ePoster presentation track: BioanalyticsForum3 - Screen 17 - Date/Time 2018-11-05 2:30

Alliance Pharma is gearing up for the #AAPS PharmSci 360 Conference in DC.  Meet Our Scientist for Poster  #M1430-03-017 - Development of an LC-MS/MS

Method for Quantification of Cytarabine in Rat Plasma. Stop by our booth #610 or schedule a meeting with us at the conference Ryan Klein 919-801-3146 or email rklein@alliancepharmaco.com.

 

It’s a great opportunity to connect with leading #pharmaceutical #scientists from across the globe!Conference Announcement Template - D

Building Stronger Collaborative Partnerships with Cutting-Edge Instruments

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By Karen Pryor October 23, 2018

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Alliance Pharma is dedicated to bringing comprehensive solutions to our collaborative partnerships.  We understand the importance of efficiency and our team of scientists strive to provide the highest analytical services for your project. 

Our recent purchase of multiple Agilent 6545XT AdvanceBio QTOFs – which is specifically designed with biopharmaceutical characterization in mind - provides high resolution and sensitivity for qualitative and quantitative analyses of biomolecules ranging from peptides to intact monoclonal antibodies. The iterative peptide mapping workflow allows us to dig deep into samples with a wide range of analyte concentrations (i.e. host cell proteins and sequence variants). The Agilent 6545XT AdvanceBio QTOF maximizes our uptime by performing thousands of protein injections without degradation of performance with mass accuracies within 10 ppm for glycosylated intact proteins. 

At Alliance Pharma we believe keeping up with the latest technology helps us to provide the best services for our clients.  The 1290 Infinity II LC system when coupled with the 6545XT, represents the next generation LC for ultrahigh-performance liquid chromatography with superior reliability, offering efficient and reproducible separations of biomolecules for detection by MS or integrated UV and FLD modules. 

By using instruments that complement our scientist’s knowledge and experience we meet analytical objectives, increase productivity, and are cost-effective.  Contact us to see how our recent instrument purchase will help keep your project on track.  Call or email Ryan at 919-801-3146 or  rklein@alliancepharmaco.com for more information.

Alliance Pharma New Hire

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By Karen Pryor October 9, 2018

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Alliance Pharma has hired Dr. Ryan Klein as Director of Business Development. Dr. Klein has more than 20 years of experience in the pharmaceutical industry developing both oral and topical dosage forms for a range of indications. Dr. Klein began his career at GlaxoSmithKline, where he was an integral component of their drug discovery organization providing drug metabolism and pharmacokinetic expertise to project teams. He was instrumental in the development and implementation of a number of in vitro and in situ ADME models to assess drug absorption, metabolism, and disposition.

After leaving GSK, Dr. Klein joined Tergus Pharma, a CRO providing topical R&D services to the pharmaceutical industry. At Tergus, Ryan filled various roles including leadership positions as the Head of Research & Development and Head of In Vitro Sciences, as the company grew from five employees to approximately seventy five over a seven year period.

Dr. Klein’s areas of expertise include drug permeability, absorption and metabolism in the gastrointestinal tract, liver and skin, intestinal drug transporters, and the anatomy, physiology, and pharmacology of the skin and GI tract. He also has a strong analytical background with extensive experience developing and validating in vitro release testing methods for semi-solid dosage forms, as well as developing and validating HPLC assay and impurities methods.

Leveraging Dr. Klein’s experience on the client side allows Alliance Pharma to collaborate on a higher level with Sponsors, using his in-depth knowledge and vast experience to align the best team of scientists to support each project.

Ryan earned his bachelor’s degree in Chemistry from Wake Forest University in Winston-Salem, North Carolina, and earned his doctoral degree in Pharmaceutical Sciences from the School of Pharmacy at the University of North Carolina at Chapel Hill. Ryan has authored & co-authored numerous scientific publications and patents, and serves as a member of several pharmaceutical research focus and discussion groups.

To read more or to connect with Ryan, view his LinkedIn profile https://www.linkedin.com/in/ryanrklein/

Alliance Pharma Bioanalytical Team Adds New Instrumentation to Expand Large Molecule Bioanalysis Capability

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By Ryan Klein September 21, 2018

Colin Barry, Ph.D. & Scott Ugrin, Ph.D.

Alliance Pharma’s bioanalytical team provides comprehensive services for both small and large molecules using a variety of platforms from mass spectrometry to ligand binding assays using an assortment of specialized instrumentation. Our analytical laboratories boast thirteen LC-MS/MS systems from three different manufacturers and include various platforms. Nine systems from AB Sciex are each coupled to Shimadzu UHPLC systems, including two API4000 QTRAP systems, two API4000 triple quad systems, three 5500 triple quad systems, and two 6500 triple quad systems. Each system is designed for high sensitivity quantitative analysis of small molecules generated from either in vitro or in vivo studies and in various matrices. Alliance Pharma’s small molecule mass-spec based bioanalytical team specializes in:

  • Development, optimization, and transfer of bioanalytical assays
  • Method Validation
  • Sample analysis to support clinical (GLP) and non-clinical studies
  • Plasma, serum, whole blood, and all tissue types
  • Biomarker assay development, validation and sample analysis
  • High throughput screening from in vitro ADME assays
  • Metabolite identification

The newest additions to the bioanalytical lab include two Agilent 6545 XT Q-ToF high resolution mass spectrometers coupled to Agilent 1290 Infinity II UHPLC systems with PDA and FL detectors. These new systems add additional capacity to our existing high-resolution accurate-mass (HRAM) systems: 1) a Dionex RSLCnano, 2-D nano/micro/cap UHPLC system coupled to a Q Exactive Plus, and 2) an Orbitrap XL from Thermo Scientific. The newest HRAM systems are ideally suited for analysis of proteins and peptides and will allow generation of highly detailed information for intact proteins and antibodies, confirmation of sequence at the peptide level, and sophisticated analysis of both simple and comprehensive post-translational modifications. The combination of mass accuracy (> 1 ppm) and high resolution (up to 280,000 at m/z 200) allow for increased specificity and sensitivity in extremely complex matrices. The additional capabilities position Alliance Pharma to continue to expand our large molecule qualitative and quantitative analysis capabilities.

Drug Transporter Panel for DDI Assessment Arrives at Alliance Pharma

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By Ryan Klein July 16, 2018

Chunying Gao, Ph.D.

Drug transporters play a key role in the absorption, distribution, metabolism, elimination and toxicity (ADME-Tox) of many drugs by controlling the entry or exit of drug molecules into and out of tissues or organs. Due to the importance of drug transporters in these processes and the potential drug-drug interactions among drug molecules on these transporters, in vitro transport studies on a standard panel of drug transporters are recommended by the FDA, EMA, and PDMA regulatory agencies to evaluate the potential interactions as substrates and/or inhibitors among the investigational drugs. The current panel includes P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1 and MATE2-K; although regulatory agencies are routinely requesting data on additional transporters outside of the current group. 

According to the FDA guidance,[1] several in vitro models are recommended for each transporter:

ABC Transporters

BCRP, P-gp

Caco-2 cells, commercial or in-house membrane vesicles, knock-out/down cells, transfected cells (MDCK, LLC-PK1, etc.)

SLC Transporters

OATPs

Hepatocytes, transfected cells (CHO, HEK293, MDCK, etc.)

OATs, OCTs

Transfected cells (CHO, HEK293, MDCK, etc.)

MATEs

Commercial or in-house membrane vesicles, transfected cells (CHO, HEK293, MDCK)

 

Alliance Pharma has established a set of cell- or membrane vesicle-based assays to support filing packages for the studies recommended by regulatory agencies. For ABC transporters, a membrane vesicle assay (for P-gp and BCRP) and MDR1/MDCK bidirectional permeability assay (for P-gp) has been established. For SLC transporters, an assay platform based on transiently transfected HEK293 cells has been optimized and validated, and can be used for both screening of substrate/inhibitor and Km/IC50 determination.

[1] https://www.fda.gov/downloads/Drugs/Guidances/UCM581965.pdf

Determination of Venlafaxine and Five Metabolites in Rat Plasma.

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By Karen Pryor June 12, 2018

This method was validated by following the US FDA guidance for bioanalytical method validation. To read more about the Validation of an LC-MS/MS method for simultaneous quantification of venlafaxine and its five metabolites in rat plasma and its application in a pharmacokinetic study click here.

VEN Publication with JCB - Rat Plasma 6-4-18

Guodong Gua,⁎, Michelle Blacka, Colt Cooksona, Anna Fiorellaa, Yinghe Lib, Steven H. Gormanc, Ray Bakhtiarc

a Alliance Pharma, Inc., Malvern, PA, United States

b GlaxoSmilthKline (GSK), Collegeville, PA, United States

c Teva Branded Pharmaceutical Products R&D, West Chester, PA, United States

Journal of Chromatography B 1087–1088 (2018) 29–35

3 Essential Features of Mass Spectrometry That Every Bioanalytical Scientist Needs to Understand

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By Dr. Mitch Johnson May 31, 2017

Scientists who specialize in developing mass spectrometric methods know that the methods must be individually tailored to successfully support a pivotal clinical trial or to provide bioanalytical support along any phase of the drug development process. A specific mode of mass spectrometry called multiple reaction monitoring (MRM) is a powerful tool because it uses multiple mass spectrometers in tandem to increase sensitivity and selectivity of analysis, generating the most reliable data. Read on to find out why this matters to experts in the fields of pharmacokinetics, bioequivalence, toxicity, and bioanalysis.

mass spectrometry scientists at work

Extreme Sensitivity

Mass spectrometry has the ability to accurately determine concentrations of biomarkers present in human matrices down to nanomolar levels. D-erythro-Sphingosine-1-phosphate (S1P) is a biomarker for certain diseases such as atherosclerosis and cancer.

Method Development and Validation for the Quantification of D-erythro-Sphingosine-1-phosphate (S1P) in Human Plasma Using LC-MS/MS

Versatility and Customization

Instrumentation techniques are customizable. Liquid chromatography tandem mass spectrometry has the ability to monitor several different classes of compounds. There are intricate parameters of mass spectrometry that can be optimized for every study. See below how LC-MS/MS techniques have been used to analyze compounds like cholesterol and ManNAc, which are endogenously present in plasma, and goserelin, a synthetic hormone used to treat prostate and breast cancer.

Quantification of 4β-Hydroxycholesterol and Cholesterol in Human Plasma Using LC-MS/MS

Method Development and Validation for the Quantitation of ManNAc in Human Plasma Using HILIC LC‑MS/MS

A Rapid and Sensitive Method for the Quantification of Goserelin in Human Plasma Using HPLC-MS/MS

Speed

By coupling liquid chromatography with mass spectrometry, concentrations of several compounds in a sample can be achieved in a run as short as 3 minutes. Whether you are interested in analyzing several different drugs or a parent compound and its metabolites, it can be done in the same run making study conduct very efficient.

SHORTCUT to CYP Enzyme Activity Monitoring

Ping Pong Madness + VIDEO

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By Jeannette Bezinque March 31, 2017

In March, thirty-two Alliance Pharma employees competed in the First Annual Ping Pong Madness Championship. The games commenced at a neck-breaking pace of back and forth and culminated with a title upset that only two bracket participants predicted. Fierce competition, a pizza party, and a pep rally made the experience a WIN for all employees, even though only one person took home the title of PING PONG MADNESS CHAMPION

Congratulations Yong! 2017 Ping Pong Madness Champion

 Ping pong madness champion Yong Lin

 

 

 

 

 

 

 

Here's a two minute clip from the match. Watch Yong's killer spike as early as 9 seconds into the video! Dr. Lin also attributes his excellent pipetting skills to his ping pong talent.  

 

 

Our spirit team really pumped up the crowd. Here's a video of the cheer that brought everyone to... cheers:

 

 You can listen to the Ping Pong Madness playlist on Spotify. 

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Bioanalytical Jobs for New Graduates

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By Jeannette Bezinque February 24, 2017

As we approach graduation season, many college seniors are beginning their bioanalytical job search on campus, online, and by networking. Entry-level jobs offered at Alliance Pharma are suitable for students with a Bachelor's or higher in the sciences such as Chemistry, Biochemistry, or Biology. New scientists thrive in this environment, where they have direct access to Ph.D. level mentors in their day-to-day lab operations. Our company also has several career paths with two stages for Analysts and two stages for Scientists and opportunities for advancement. 

bioanalytical jobs career path

Reasons to apply for bioanalytical jobs at Alliance Pharma:

  • Rapid Growth - Dr. Feng Li, President, is a two-time winner of the Smart CEO Future50 award
  • Career Support - Working in a small pharmaceutical company setting gives novice researchers access to more complex and challenging assignments.
  • Mentorship - Alliance Pharma prides itself on the ability to hire young talent and nurture them through the initial stages of lab work. 

 

In the video below, Kale Drost (Ursinus '15) and Anna Fiorella (Ursinus '16) share their post-college career experience. They offer anecdotes of working in the bioanalytical laboratory and demonstrate a few scientific study processes. Be sure to listen as to what you can expect in the real world in the words of two Alliance Pharma employees. 

“Enjoy the time you have left in school because you will miss it.” -Anna

 

Here are 5 tips to make a GREAT Impression with your job resume

  1. Check for typos or misspellings.
  2. Include any relevant volunteer work and honors.
  3. Use the keywords scientific researchers seek in new hires- LC-MS/MS, mass spectrometry, sample extraction, instrument maintenance, etc.
  4. Don't over-exaggerate your lab experience.
  5. Keep it to one page, especially if you are an entry-level candidate with a Bachelor's degree.

 

Get to know Alliance by following our LinkedIn page for career postings and frequent updates. We also post job openings directly on our site. 

9 Bioanalytical Studies using LC-MS/MS

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By Dr. Feng Li February 21, 2017

 

Over the years, our scientists have been tasked with a variety of complex LC-MS/MS studies. In their research, they worked to produce cost-saving procedures, deliver reproducible results, and employ automation technologies. 

Here is an overview of the Bioanalytical study research presented at scientific conferences over the past four years. Click the links to view the full poster; including analysis, details, and conclusions.

lc ms ms word cloud lc ms ms tandem mass spectrometry mass spectrometry analysis bioanalysis method validation what is mass spectrometry how to read mass spectrometry test method validation method development analytical method validation preclinical studies bioanalytical method validation hplc ms ms lc mass spec bioanalytical laboratory services mass spectrometry validation of an analytical method method validation steps analytical method development lc ms ms analysis mass spect mass spectrometry lc lc ms ms method development and validation mass spectro meter pk pharmacokinetics bioanalytical services what is lc-ms lc mass spectrometry mass spectrometry ms lc lc ms mass spectrometry lc-ms/ms lc-ms lc msms method development

1.) Prove Microsampling accuracy with LC-MS/MS 

Mouse Pharmacokinetic Study of Ceftriaxone Using Mitra™ Microsampling Devices and LC-MS/MS

In this study, an experiment was designed to compare a serial blood sampling method using Mitra™ microsamplers with parallel blood sampling methods using both Mitra™ microsamplers and venipuncture.

2.) Automate the work of quantifying S1P in Human Plasma using LC-MS/MS

Method Development and Validation for the Quantification of D-erythro-Sphingosine-1-phosphate (S1P) in Human Plasma Using LC-MS/MS

An automation friendly LC-MS/MS method with a calibration range of 10 to 400 ng/mL was developed and validated to support clinical trials using S1P as a biomarker.

3.) Quantify HMF and HMFA in Human Plasma with LC-MS/MS

Method Development and Validation for the Quantitation of HMF and HMFA in Human Plasma Using LC-MS/MS

A method for the quantitation of HMF and one of its major metabolites, 5-hydroxymethyl-2-furoic acid (HMFA), has been developed and validated in commercially available human plasma by Alliance Pharma. 

lc ms ms alliance pharma scientists

4.) Confirm stability with rapid and sensitive LC-MS/MS method

SHORTCUT to CYP Enzyme Activity Monitoring

A rapid and sensitive LC-MS/MS method was validated for cortisol and 6ß-HC analysis
in human urine. Method accuracy, precision, repeatability, selectivity, F/T stability, processed sample stability, bench-top stability, and long term stability have been confirmed.

5.) Evaluate drug-drug interactions during LC-MS/MS clinical studies

Quantification of 4b-Hydroxycholesterol and Cholesterol in Human Plasma Using LC-MS/MS

The plasma concentration ratio of 4b-hydroxycholesterol (4b-HC) to cholesterol has been recognized as a reliable marker for the assessment of Cytochrome P450 (CYP) 3A4 activity. It could be a valuable yet simple and cost effective side-product of a clinical study to evaluate CYP3A4-mediated drug-drug interactions.

6.) Support a Phase I clinical study with an LC-MS/MS method

Method Development and Validation for the Quantitation of ManNAc in Human Plasma Using HILIC LC-MS/MS

The purpose of this study was to develop and validate an LC-MS/MS method for assaying N-acetylmannosamine (ManNAc) in human plasma (K2EDTA) to support a phase I clinical study.

7.) Measure Goserelin in human plasma using LC-MS/MS

A Rapid and Sensitive Method for the Quantification of Goserelin in Human Plasma Using HPLC-MS/MS

The purpose of this study was to develop and validate a rapid and sensitive LC-MS/MS method for measuring Goserelin in human plasma (K2EDTA).

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8.) Determine the quantification of 25-hydroxyvitamin D3 with an LC-MS/MS method

Quantification of 25-hydroxyvitamin D3 in Rat Serum Using Derivatization to Enhance LC-MS/MS Sensitivity

In this study, a sensitive and robust LC-MS/MS method was developed and validated for the determination of 25-OHVD3 in rat serum.

9.) Quantify Mercaptoethanol through LC-MS/MS analysis

Quantification of 2-Mercaptoethanol in Bulk Drug Substance by LC-MS/MS

Here, we report a LC-MS/MS method that utilizes derivatization with picolinic acid to quantitatively analyze residual mercaptoethanol and has been successfully used in biopharmaceutical manufacture.