NEWS: Our Blog

Notable Achievements of 2016

Jan 19, 2017 3:46:53 PM / by Jeannette Bezinque posted in Feng Li, laboratory

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In 2016, Alliance Pharma had many notable achievements. One of the reasons that we continue to see growth year after year is the strong leadership of Dr. Feng (Frank) Li. For a second year in a row, Alliance Pharma was recognized with SmartCEO Future 50 award as Philadelphia region’s fastest growing mid-sized companies for 2017. From an increase in laboratory space and personnel to a host of new instruments, Alliance Pharma’s expansion facilitates an agile and adaptive environment to meet the specialty research needs of our clients—some of the world's best pharmaceutical companies.

By opening the laboratory animal facility in April 2016, Alliance began to offer in-life dosing studies and created three vivarium technician jobs. We also added critical research space for light-sensitive compounds. Nearby, a new temperature and humidity control unit upgraded our archive room storage capabilities. A few months ago, a crane arrived to deliver an AC unit for the new large-molecule mass spectrometry laboratory. In addition to space enhancements, we also added several new pieces of equipment.

Brand New Equipment Purchased in 2016

  • Thermo Scientific Q Exactive Plus High-Resolution Mass Spectrometer
  • Another Hamilton Robotics Automated Liquid Handling System
  • Another Meso Sector Imager S600 Microplate Reader  
  • Three additional High-Performance Liquid Chromatography (HPLC) systems
  • Five additional laboratory freezers
  • Beckman Coulter AU480 Chemistry Analyzer

 

System Formalization

As part of our commitment to continuous improvement in service, we updated our quality manual and disaster recovery plan. 

A new software system was implemented to facilitate project management for each department. We also implemented a secure, digital sample management system to easily track data about storage and shipments. Laboratory operations has made improvements in the instrument inventory system, chemical and solvent inventory system, reagent inventory system, and HPLC column tracking system. Also, we have partnered with excellent providers to streamline our accounting and human resources systems.

Finally, a Training Coordinator was appointed to improve our on-boarding process for new employees and to identify areas for staff training and development. Since our company grew by over 50%, this was a much-needed organizational structure.

New Hire Spotlights

Our workforce grew to a total employee count of 63 in 2016. You can check out some of our staff announcements on our LinkedIn page. Our leadership team additions this year include Dr. Weiqing Chen, Dr. Wei Lu, and Dr. Colin Barry.

 

2016 notable achievements update.png

 

Notable Achievements in Social Media

On December 29th, we relaunched our site with Hubspot to deliver innovative and helpful content about the pharmaceutical research industry.

We gained our 100th Twitter follower on December 15. Thank you @ArcturusRX!

Eight team members worked together to create our first social media video, the #mannequinchallenge.

Over 1000 people saw our October 19 LinkedIn update.

Follow us on LinkedIn

Check us out on LinkedIn, Twitter, Facebook, or on our blog to read more about this year’s highlights. 


 

Future Direction

Our promise for 2017 is to continue to strengthen our specialties. We will continue to emphasize quality, compliance, and skill training. It is important for us to continue to improve our operational efficiency.  We plan to achieve new levels of productivity by further standardizing and harmonizing processes, and automating procedures, wherever possible. As always, we seek to deliver the highest quality data and in the most timely expectations. 



 

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Customer Survey Results for 2016

Dec 14, 2016 3:20:00 AM / by adminweb_1 posted in Pharmaceuticals

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In 2016, Alliance Pharma conducted a Customer Survey to measure satisfaction of our bioanalytical, biopharmaceutical, and drug metabolism services to our clients. Our goal was to assess how we were performing in relation to our business philosophy. Since we measure our success based on the success of our clients, it is important that we understand the areas of our business that are working and the areas that need improvement.

Overall, 100% of clients who responded to our survey gave Alliance Pharma a rating of SATISFIED or higher in regards to questions about services, personnel, performance, support, management, and costs. In fact, 75% of clients stated that they are VERY SATISFIED with Alliance Pharma.

customer survey results very satisfied

The Customer Survey went out to Scientific Directors, Senior Research Directors, Assistant Scientists, Senior Managers, and Professors. When these clients were asked, “How satisfied are you with the performance of our technicians?” 70% replied that they are VERY SATISFIED. In addition, 65% of our clients responded that they are VERY SATISFIED with our management’s commitment to assist.

Customer Survey Data

We also used the survey to understand why our clients are choosing to partner with us. We know that there are many CROs in the marketplace, so we value each and every client. The replies showed that our network is strong and that referrals are the number one factor for our clients choosing to partner with us. The survey also revealed that our clients are choosing us for other reasons, as follows:

  • Timing
  • Cost
  • Quality
  • Location
  • Assay Capability

Customer Focused Improvements

Based on the results of the survey, we plan to update our website design and functionality. We will also create new company literature to describe the full extent of our services, especially those that we have added this year, such as the Laboratory Animal Facility and Large Molecule Bioanalysis.

Alliance Pharma would like to thank all of our customers for their time in completing the survey to help us understand how we can better serve all your needs! We are committed to delivering the highest quality services at a competitive price, and thus build a lasting partnership. Thank you for your continued patronage.

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Conference for Pharmaceutical Scientists AAPS2016

Dec 7, 2016 4:47:00 AM / by adminweb_1 posted in Conferences

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On November 13, our team of top scientists traveled to Denver, Colorado for the 2016 AAPS Annual Conference for pharmaceutical scientists. The conference was kicked off with a keynote address from Daniel Fletcher, PhD who discussed novel technology, new delivery modalities, accelerated drug development, and precision medicine. Our booth, which was serendipitously situated next to the Rest and Relaxation Lounge, welcomed a host of pharmaceutical professionals, academic leaders, and job-seekers. Visitors received an Alliance Pharma lunchbox or a handy letter opener.

conference for pharmaceutical scientists swag

Many connections were made at the various networking events like the Welcome-Reception, the American Chinese Pharmaceutical Association Meeting, and the 80’s Party hosted by Core RX and Mutchler Inc. Presenters and attendees at the conference included Teva, BASF, Agilent, Triangle Research Labs, Science Exchange, MedPace, and Pfizer, to name a few. Many members of the FDA were also onsite.

Researchers seeking a CRO (contract research organization) find value in the conference because they can make a trusted in-person connection and quickly discern the qualities of a specific CRO. For example, the ideal CRO offers quick-turn around, high-quality data, and competitive pricing. The conference was also an opportunity to share updates on our company. This year, Alliance Pharma had added a Vivarium for animal research studies and a new lab for Large Molecule Bioanalysis.

Tweets from #AAPS2016

Dr. Meng Feng presented a poster on microsampling titled Mouse Pharmacokinetic Study of Ceftriaxone Using MitraTM Microsampling Devices. (View the full details here.) In his work with a group of Alliance colleagues, Dr. Feng concluded that MitraTM microsampling devices provide a methodology that can be used for serial blood sampling in drug discovery mouse studies, and which could reduce costs, improve animal welfare, and save precious test articles.

Dr. Yong Lin presented a poster on Adaptation and Validation of a Multiplex Assay Kit for the Quantitative Analysis of Aβ38, Aβ40, and Aβ42 Peptides in Cynomolgus Monkey Plasma at AAPS. (View the original poster here.)

2017 Conference for Pharmaceutical Scientists

If you are seeking another conference for pharmaceutical scientists, consider joining us in 2017 at one of our upcoming events. View the full conference schedule here.

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

Oct 21, 2016 1:32:00 PM / by Dr. Feng Li posted in lc-ms/ms

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Purpose

Blood sampling is a common and important specimen collection procedure used in research. One of the most commonly used animals in drug discovery pharmacokinetic (PK) studies are mice. Animal research guidelines exist that limit the frequency and amount of blood that can be collected from a single animal. In mice, due to their limited body size, parallel blood sampling is generally used whereby multiple mice are subjected to a single blood draw through cardiac puncture. Oneissue with parallel sampling, however, is that the number of mice required for a study can be large. Consequently, the amount of test compound required for doseadministration will also be large.
Repeated or serial sampling in a single animal, on the other hand, is often difficult, especially when cannulation is not an option. MitraTM microsampling devices (Neoteryx LLC) offer an alternative method for serial blood sampling in mouse PK studies. Using serial blood sampling rather than parallel blood sampling may greatly reduce the number of animals needed and lead to more reliable data by excluding individual differences. 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.

microsampling lc-ms/ms

Method

Animal Experiment Design

Species: CD-1 mice
Compound: Ceftriaxone
Dosing: 1 mg/kg IV, single dose (Groups 1 and 2);
5 mg/kg PO, single dose (Groups 3 and 4)
Vehicle: 0.9% sodium chloride (saline) solution
IV Time Points: 0.083, 0.25, 0.5, 1, 2, 4, 7, and 24 hours
PO Time Points:0.25, 0.5, 1, 2, 4, 7, and 24 hours
•Group 1 (IV) and Group 3 (PO)-Parallel Sampling (3 mice per time point per dose route) - At each time point, blood samples (10 μL) were collected from the lateral tail vein of each mouse using Mitramicrosamplers, and blood samples were collected by single venipuncture for plasma analysis.
•Group 2 (IV) and Group 4 (PO)- Serial Sampling (3 mice per dose route) - At each time point, blood samples (10 μL) were collected from the same mice using Mitra microsamplers


Mitra Sample Extraction

•Mitra microsampler tips were removed and soaked in 100% water to achieve better recovery of relatively polar compound ceftriaxone.
•Protein was precipitated using acetonitrile with internal standard (d3-ceftriaxone). Supernatant was dried down and reconstituted before injection.

LC-MS/MS Conditions

UHPLC : Shimadzu Nexera X2 LC-30AC
Column: Agilent Zorbax SB-C18
Mobile Phases: A: 0.1% formic acid in water
B: 0.1% formic acid in acetonitrile
Mass Spectrometer: AB SCIEX Triple Quad TM5500
Ion Transitions: m/z555.1→396.1for ceftriaxone
m/z558.1→399.0 for d3-ceftriaxone

PK Calculations

Noncompartmental models using the Phoenix®WinNonlin®software

Conclusion

  • Extraction method from Mitra microsampling devices was optimized to improve the recovery of ceftriaxone, a relatively polar compound.
  • Comparable concentration results and PK parameters were obtained using the Mitra microsampling method and traditional blood sampling method after both IV and PO dosing.
  • Mitra microsampling devices provide a viable alternative for serial blood sampling in mouse drug discovery studies.
  • The use of Mitra microsampling devices could reduce costs, improve animal welfare, and save precious test articles.

 

Acknowledgements

Meng Fang, Gordon Gu, Brandon Milan,Bobby Virasingh, Ashley Groff, Jamie Freed, Catherine Clifton, Deping Cheng, Yinghe Li
Alliance Pharma, Inc., 17 Lee Boulevard, Malvern, PA 19355
Neoteryx LLC, 421 AmapolaAvenue, Torrance, CA 90501

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Dr. Weiqing Chen to Head Alliance Pharma’s Drug Metabolism Department

Sep 30, 2016 5:01:00 AM / by adminweb_1 posted in Uncategorized

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drug metabolism scientist, DMPK, weiqing chen, alliance pharmaAlliance Pharma is pleased to announce the appointment of Weiqing Chen, PhD, to the position of Director, Drug Metabolism. Dr. Chen brings more than 14 years of research and industry experience in drug discovery and development. He established the DMPK (drug metabolism and pharmacokinetic) service capability at a leading CRO in China. While there, he developed stable business relationships with more than 100 clients in US, Europe, Japan, and China. He led the DMPK effort in numerous integrated drug discovery and development programs. He also made significant contributions in designing and managing preclinical DMPK studies for regulatory filings in the US and China. His most recent publication was “Amlodipine metabolism in human liver microsomes and roles of CYP3A4/5 in the dihydropyridine dehydrogenation,” published in the Drug Metabolism and Disposition Journal.

We are thrilled to welcome Dr. Chen for his expertise in designing and conducting ADME studies, as well as LC-MS/MS method development and sample analysis. Frank Li, PhD, Co-founder and President of Alliance Pharma, acknowledged, “With Weiqing’s many years of DMPK experience, knowledge, and strong leadership, Alliance Pharma will continue to provide clients with the highest level of service.” Dr. Chen is excited to share our passion for providing high-quality DMPK services to the growing needs and expectations of our international clients.

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Gordon Research Conference on Drug Metabolism 2016

Jul 20, 2016 5:05:00 AM / by adminweb_1 posted in Conferences

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Alliance Pharma attended the Gordon Research Conference on Drug Metabolism on July 10–15, 2016. The conference took place at the Holderness School in Holderness, NH. Alliance Pharma was one of the sponsors of the conference. The conference brings together industry, academic, and regulatory scientists with interests in Drug Metabolism. The goal of the conference was to address the revolutionary changes happening in the discovery of highly selective medicines and therapeutic regimens for patients with inherited and acquired diseases.

Gordon research conference on drug metabolism

Pictured: conference attendees including Dr. Michael Liu, Dr. Zhiyang Zhao , and Dr. Karsten Holm from Alliance Pharma.

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AAPS Distinguished Service Award to Masood Khan

May 17, 2016 5:11:00 AM / by adminweb_1 posted in Leadership

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masood khan AAPS awardAlliance Pharma’s Vice President of Biopharma Services, Masood Khan, Ph.D., was honored with the BIOTEC Section Distinguished Service Award at the 2016 National Biotechnology Conference of the American Association of Pharmaceutical Scientists (AAPS). The AAPS Distinguished Service Award recognizes exemplary service as reflected in significant and extensive contributions that have materially influenced the advancement of the pharmaceutical sciences and the AAPS.

To date, Dr. Khan has over 120 publications and presentations, including several white papers related to issues in bioanalysis that focus on new technologies and biomarkers. One of these white papers titled, “Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development,” which was published in the journal of Bioanalysis (January 2015), offered a systematic approach to the assessment, method adaptation, and validation of commercial immunoassay kits for the quantification of biomarkers in drug development. Dr. Khan is also editor of a book titled, Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena (2009)—a consolidated and comprehensive reference that is still used extensively in the pharmaceutical industry.

Dr. Khan has been an extraordinary volunteer, actively involved in AAPS over the past two decades, serving on a variety of committees, as well as organizing scientific short courses, roundtables, and symposia. Most notable is a roundtable that he organized at the AAPS 1998 Annual Meeting in San Francisco on the challenges of immunoassay validation and implementation in regulatory environment. This led to the publication of the first white paper on the industry perspectives on ligand-binding assay validation in 2000 and subsequently to the formation of the Ligand-Binding Assay Bioanalytical Focus Group (LBABFG), where he has actively served on the Steering Committee for over 8 years. He is currently acting as the Liaison of the BIOTEC Section Focus Groups.

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

Nov 2, 2015 11:19:00 AM / by Dr. Feng Li posted in lc-ms/ms

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D-erythro-Sphingosine-1-phosphate(S1P), a bioactive lysophospholipid, is an important mediator of inflammation, atherosclerosis, and cancer. S1P is proposed as a clinical biomarker and diagnostic variable in fundamental research, routine testing, and large-scale clinical trials due to its signaling transducer functions.

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.

LCMsMS method development.jpg

Sample Extraction

Challenge in Quantitative Recovery

The bipolar structure of S1P presented a challenge during extraction due to its tendency to accumulate in the aqueous/organic interface.

Overall recovery was 91.3% for S1P and 109.5% for S1P-d7.

Extraction Method

  • A 50-uL sample size was used with internal standard S1P-d7. 
  • Recovery was improved by using a liquid-liquid extraction with 10% formic acid (FA) in methyl tert-butyl ether (MTBE) as a solvent. 
  • Partial supernatant was dried, reconstituted, and injected into the LC-MS/MS system.

 

LC-MS/MS Method

LC-MS/MS Conditions

HPLC: Shimadzu LC-20AD

Column: Thermo Acclaim C8, 50x2.1mm, 5um

Mobile phase A: 0.1% formic acid in water

Mobile phase B: 0.1% formic acid in acetonitrile

Flow rate: 0.8 mL/min

MS/MS Detection

Mass Spectrometer: AB Sciex API 4000

Ionization mode: ESI positive ion mode

Source temperature: 500° C

Ion transition monitered:

S1P: 381 → 264

S1P-d7: 388 → 271

Results

S1P Calibration Curve

The assay showed a linear calibration range of 10 to 400 ng/mL. The curve was linear (R² > 0.998) using weighted 1/x² regression. 

Chromatography and Method Sensitivity

Representative chromatograms of the quality control at the lower limit of quantification (LLOQ-QC, 10 ng/mL) and blank surrogate matrix (2% bovine serum albumin [BSA] cleaned with active charcoal).

Matrix Effect

No matrix effect was observed when QCs prepared in matrix were compared with those prepared in neat solution

S1P Endogenous Concentration

The endogenous level of S1P in 6 lots of screened blank matrix ranged from 19.1 to 157 ng/mL. A single lot was quantified (150 ng/mL) and used to prepare MQC (endogenous level) and HQC (200 ng/mL + endogenous level) samples.

Conclusions

  • A sensitive, selective, and automation friendly method capable of assaying S1P in human plasma was developed and validated to support clinical trials using S1P as a biomarker.
  • Excellent recovery of S1P was achieved by adjusting the extraction solvent composition.
  • The method could be applied to other phospholipids that pose similar challenges in quantitative recovery.

 

Acknowledgement

Guodong (Gordon) Gu, Michelle Black, Deping Cheng, Yinghe Li, Yifan Shi, Meng Fang, Lynn Maines
Alliance Pharma, Malvern, PA; Janssen Research and Development, Spring House, PA; Apogee Biotechnology Corporation, Hummelstown, PA

This study was financially supported by Apogee Biotechnology Corporation.

 

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Zhiyang Zhao, Chief Scientific Officer

Sep 15, 2015 5:26:00 AM / by adminweb_1 posted in Leadership

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Alliance Pharma is pleased to announce that Zhiyang Zhao, PhD, has joined its leadership team as Chief Scientific Officer (CSO).

zhiyang zhao, chief scientific officer, alliance pharma

Dr. Zhao brings to Alliance Pharma over 20 years of pharmaceutical industry experience with special focus on metabolic and pharmacokinetic properties of small and large molecules in drug discovery and development. Dr. Zhao has previously held positions at Pfizer, GlaxoSmithKline, and Amgen. Most recently, Dr. Zhao served as Amgen’s Site Director for Preclinical Studies at Cambridge, Massachusetts, for over 11 years. He previously served as a Director at GlaxoSmithKline and as an Investigator at Pfizer. His extensive experience spans the entire drug discovery and development process (discovery, development, and in-/out-licensing) in oncology, metabolic, antiviral, CNS, and inflammatory diseases.

Dr. Zhao’s contributions and accomplishments of integrating in vitro and in vivo ADMET (absorption, distribution, metabolism, excretion, and toxicity) information to optimize drug candidate properties are documented in over 50 peer-reviewed scientific publications and patents in the areas of new drug targets, drug metabolism, pharmacokinetics, and toxicology. He currently also holds an appointment as Adjunct Professor at the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill, North Carolina, and serves as the Editor-In-Chief for Drug Metabolism Letters.

“We are thrilled to have Dr. Zhao on our scientific leadership team; he will further strengthen and broaden our scientific excellence in the services that we provide,” said Frank Li, PhD, Co founder and President of Alliance Pharma. “In his role as CSO, Dr. Zhao, will provide scientific, intellectual, and managerial leadership as well as explore scientific and business opportunities beyond Alliance Pharma’s current scope of business.”

Dr. Zhao expressed his excitement in joining the diverse team at Alliance Pharma, stating, “I look forward to working with the talented team at Alliance Pharma as we explore new business opportunities and expand our scientific and technical capabilities to better serve our clients. Having spent more than two decades in various leadership roles in pharmaceutical companies, I fully understand our clients’ challenges and needs.”

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

Jun 1, 2015 11:43:00 AM / by Dr. Feng Li posted in lc-ms/ms

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5-Hydroxymethylfurfural (HMF) is a water-soluble heterocyclic organic compound derived from sugars. HMF binds with high affinity to intracellular sickle hemoglobin (HbS). In vivo studies using transgenic sickle mice showed that orally administered HMF inhibits the formation of sickled cells in the blood. NIH and its collaborators conducted investigations into the possibility of HMF as a treatment of Sickle cell disease (SCD) which is characterized by an abnormality in the oxygen-carrying haemoglobin molecule in red blood cells. 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.

LCMSMS method development HMF.png

Method

The standards and QCs were spiked with stable-isotope labeled HMF/HMFA as internal standards and extracted by protein precipitation with 0.1% formic acid in acetonitrile in a phospholipid removal plate. The eluent was evaporated to dryness and the residue was reconstituted with acetonitrile:water (10:90). The analysis was conducted utilizing a Schimadzu Prominence 20AC HPLC system coupled with SRM detection in ESI positive mode for HMF and in ESI negative mode for HMFA on a Sciex API 4000 Q Trap mass spectrometer. Chromatographic separation was achieved using an Atlantis T3 column with 0.02% acetic acid in water and 4 mM ammonium formate in methanol as the mobile phases.

LC-MS Conditions

Chromatographic Conditions
HPLC: Shimadzu LC-20AC
Column:Waters, Atlantis T3, 100x2.1mm, 3 μm
Column Temperature: 40oC
Mobile phase A: 0.02% acetic acid in water
Mobile phase B: 4 mM ammonium Formate in methanol
Flow rate: 0.6 mL/min

MS/MS Detection

Mass spectrometer: Sciex API 4000 Q Trap
Source temperature: 550oC
Ion transition monitored:
HMF: ESI positive mode
m/z 126.9 → 53.1
HMFA: ESI negative mode
m/z 141.0 → 69.2

Precision and Accuracy of Spiked QCs for HMF

Spiked quality control sample precision and accuracy were demonstrated at n = 6 at the lower limit of quantification (5 ng/mL) in one validation run, and at low (15 ng/mL), medium (150 ng/mL) and high concentrations (1500 ng/mL) over three validation runs.

Precision and Accuracy of Spiked QCs for HMFA

Spiked quality control sample precision and accuracy were demonstrated at n = 6 at the lower limit of quantification (0.1 μg/mL) in one validation run, and at low (0.3 μg/mL), medium (6 μg/mL) and high concentrations (75 μg/mL) over three validation runs.

Conclusion

  • A selective and sensitive HPLC-MS/MS method for the quantification of HMF and HMFA in commercially available human plasma was developed. 
  • Great retention and selection of highly hydrophilic compounds were achieved using carefully selected HPLC column and optimized mobile phases.
  • Phospholipid removal plate was used to decrease the ion suppression resulted from the phospholipids in the protein precipitation extract.
  • The method was validated as linear, accurate, precise and reproducible.

 

Acknowledgements

Meng Fang, Yifan Shi, Yinghe Li, Michael Zhang, Bradley Gillespie, Warren Stern, Amy Wang, Nora Yang, and Xin Xu
Alliance Pharma, 17 Lee Boulevard, Malvern, PA 19355; Leidos Biomedical Research Inc., Frederick, MD 21701; AesRx, LLC, Newton, MA 02466; TRND, National Center for Advancing Translational Sciences, NIH, 9800 Medical Center Dr., Rockville, MD 20850

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