Analytical Development

Cambridge, MA, United States

Analytical Development

Cambridge, MA, United States
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Dixit N.,Drug and Combination Product Development | Salamat-Miller N.,Drug and Combination Product Development | Salinas P.A.,Analytical Development | Taylor K.D.,Drug and Combination Product Development | Basu S.K.,Drug and Combination Product Development
Journal of Pharmaceutical Sciences | Year: 2016

This study investigated the root cause behind an observed free fatty acid particle formation and resulting Polysorbate 20 (PS20) loss for a sulfatase drug product upon long-term storage at 5 ± 3°C. Reversed- phase chromatography with mass spectrometric analysis as well as charged aerosol detection was used to characterize the peaks associated with the intact and degraded PS20. Additionally, a proteomics study was undertaken to identify the residual host cell proteins in the sulfatase drug substance. PS20 stability studies were conducted in the presence of sulfatase, a sulfatase inhibitor, putative phospholipase B-like 2, and mock drug substance produced using a null cell line vector under experimental conditions optimized for PS20 degradation. This study provides the first published evidence where the residual host cell protein present in the drug substance was identified and experimentally shown to catalyze the breakdown of PS20 in a protein formulation over time, resulting in free fatty acid particles and PS20 loss. This study demonstrates the importance of early detection of potential impurities in the protein drug substance that may contribute to polysorbate degradation to make a judicious selection of the surfactant and its optimized concentration for the final drug product. © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

MIAMI, Feb. 16, 2017 (GLOBE NEWSWIRE) -- The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today announced the appointment of Matthew C. Gosnell, Ph.D., as Senior Vice President of Manufacturing, Preclinical and Pharmaceutical Development, effective February 15, 2017.  Gosnell has a Ph.D. in analytical chemistry and more than 20 years of experience in pharmaceutical manufacturing, development and sourcing.  His experience ranges from preclinical and investigational new drugs (INDs) through 505(b)(2) and 505(b)(1) New Drug Applications (NDAs) and commercialization.  He will be responsible for identifying clinical and commercial manufacturing partners, chemical synthesis and process scale up development, development and clinical trial materials manufacturing and processes, documentation and submissions related to chemistry, manufacturing and control. “An accomplished scientist and drug developer, Dr. Gosnell brings hands-on experience in strategic planning and execution of process development and manufacturing of both early and late stage drug products,” said Mitchell Steiner, M.D., President and Chief Executive Officer of The Female Health Company / Veru Healthcare.  “He has extensive knowledge and expertise in leading multiple projects in various stages of development and identifying and managing new drug manufacturing sites for clinical development and commercial supply.  Over his career, Dr. Gosnell has made significant contributions to several 505(b)(2) and 505(b)(1) NDAs including Celebrex®, Risperdal® Consta® and Vivitrol® and served in senior level positions with GTx, Alkermes, Pharmacia, McNeil Specialty Products (a division of Johnson & Johnson) and Miles (a unit of Bayer AG).” Prior to joining the Company, Dr. Gosnell served as Senior Director, Product Development and Analytical Sciences for GTx, Inc., where he advanced multiple drug candidates into successive clinical stages of development.  Earlier in his career, he was Director, Quality Technical Services (Analytical Development and Stability) for Alkermes, Inc., Analytical Team Leader for Pharmacia Research and Development and Senior Scientist at McNeil Specialty Products Company.  Dr. Gosnell began his career as Scientist with Miles, Inc., after earning a Doctoral degree in Analytical Chemistry from Oklahoma State University and a Bachelor of Science degree in Chemistry and Mathematics-Computer Science from Manchester College. About The Female Health Company / Veru Healthcare The Female Health Company / Veru Healthcare is a pharmaceutical and medical device company, with a focus on the development and commercialization of pharmaceuticals that qualify for the FDA's 505(b)(2) accelerated regulatory approval pathway as well as the 505(b)(1) pathway.  The Company does business both as "Veru Healthcare" and as "The Female Health Company" and is organized as follows: More information about the Female Health Company and its products can be found at, and  For corporate and investor-related information about the Company, please visit

- Dr. Larrieux brings significant experience managing analytical development quality control of immunotherapies to treat cancer and small molecule therapies at pharmaceutical and biotechnology organizations NEW YORK, Dec. 19, 2016 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today that Jeannine Larrieux, Ph.D. has been appointed Director of Analytical Development. Dr. Larrieux will be responsible for analytical assay development, conducting biologics license application (BLA) and investigational new drug (IND) enabling studies, authoring CMC analytical sections for BLA and IND filings and supporting both internal and external quality assurance (QA) and quality control (QC) efforts. “Dr. Larrieux is an accomplished analytical professional who is bringing over 20 years of highly relevant industry experience in matters related to regulatory submissions, project management and QA/QC to Actinium,” said Sandesh Seth, Actinium’s Executive Chairman. “Dr. Larrieux is yet another invaluable addition to the Actinium team that will contribute enormously to the development of our clinical programs Iomab-B and Actimab-A as well as future clinical programs we hope to unveil in the near future.” Dr. Larrieux joins Actinium following analytical consulting assignments in the U.S. and Europe. Prior to this, she was Head of AS&T at Novartis where she focused on cell therapy products aimed to treat acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). Prior to Novartis, Dr. Larrieux was Laboratory Manager at Dendreon Corporation where she supported Phase 3 and Phase 4 clinical studies. In addition, Dr. Larrieux has worked at Pfizer, Purdue Pharma and Wyeth in analytical roles. Dr. Larrieux earned her Ph.D. in Material Chemistry from Polytechnic Institute of NYU, an M.S. degree in Chemistry from Polytechnic University and a BS.c. degree in Chemistry from State University of HAITI (PAP). In addition, she is a member of the Regulatory Affairs Professionals Society (RAPS) and a member of the American Society for Quality (ASQ). Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit and to follow @ActiniumPharma on Twitter please visit, This news release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

News Article | December 28, 2016

The key to solving the glycosylation puzzle stands with N‐glycosylation analysis of a development‐phase glycoprotein, having multiple glycosylation sites using these orthogonal methods demonstrated that complementarity. Most structures were simply identified by public database search either by Expasy or GUcal, based on their molecular weight or measured glucose unit values. Glycan structures not included in the GuCal database were deciphered by exoglycosidase‐based glycan sequencing, to sequentially remove the sugar residues from the nonreductive end of the glycan structures. In this presentation, attendees can expect a compelling discussion on the complementarity of various liquid phase bioseparation methods including capillary electrophoresis and liquid chromatography. Participants will learn how to separate and identify N-Glycans in minutes and compare liquid phase separation methods for N-Glycan analysis. They will also receive an introduction to the new Fast Glycan Labeling & Analysis Kit from SCIEX, along with 60-minute sample prep for up to 96 glycan samples. The speaker for this webinar will be Laura Salmeron, associate director analytical testing support at Halozyme Therapeutics Inc. As an industry veteran, Salmeron has more than 25 years of experience working in the clinical and biotechnology field supporting protein therapeutics. She earned her Bachelor in Science in biochemistry and microbiology and medical technologist from the University Autonoma of Guadalajara, Mexico. In 2015 Laura joined Halozyme Therapeutics in San Diego CA, working with Halozyme Enhance platform partners and leading the Potency group and as a key member of the Analytical Development team working with FIH, Clinical and Commercial products supporting method transfers at CRO’s and CMO’s and regulatory submissions. The free webinar will be hosted by LabRoots February 1, 2017, beginning at 8 a.m. PT, 11 a.m. ET. To read more on this event, learn about P.A.C.E. and Florida continuing education credits, or to register, click here. About SCIEX SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to find answers to the complex analytical challenges they face. The company's global leadership and world-class service and support in the capillary electrophoresis and liquid chromatography-mass spectrometry industry have made it a trusted partner to thousands of the scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics and clinical research. With over 40 years of proven innovation, SCIEX excels by listening to and understanding the ever-evolving needs of its customers to develop reliable, sensitive and intuitive solutions that continue to redefine what is achievable in routine and complex analysis. For more information, please visit About LabRoots LabRoots is the leading scientific social networking website and producer of educational virtual events and webinars. Contributing to the advancement of science through content sharing capabilities, LabRoots is a powerful advocate in amplifying global networks and communities. Founded in 2008, LabRoots emphasizes digital innovation in scientific collaboration and learning, and is a primary source for current scientific news, webinars, virtual conferences, and more. LabRoots has grown into the world’s largest series of virtual events within the Life Sciences and Clinical Diagnostics community.

News Article | February 16, 2017

SSCI, a division of Albany Molecular Research Inc. has further extended its industry leading Biochemistry Services specifically targeting the rapidly growing needs of the biopharmaceutical sector. This service offers state-of-the-art cGMP techniques and methods for the biochemical and biosimilar characterization, product-related impurity characterization, aggregation state characterization, structure elucidation, protein formulation development, comparability, analytical method development and validation, and protein and peptide crystallization. Included in the diverse array of services available, an ultra-high resolution Q-TOF mass spectrometry is the cornerstone – a state of the art instrument that significantly enhances SSCI’s capabilities in analysis and data interpretation for large molecules, including biologic drugs such as antibodies and antibody-drug conjugates, metabolites and polymers to meet the expectations outlined in the ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products. “Innovative proteins and biopharmaceuticals comprise the fastest growing class of new chemical entities in the industry,” commented Patrick Tishmack, PhD, Director Analytical Development , who leads the Biochemistry Services at SSCI. “Many of these therapeutic proteins typically exist in the solid state as lyophilized powders during their manufacture or in a final formulation. Few proteins are produced as crystals or formulated as mixtures of crystalline and amorphous protein. Therefore, SSCI is uniquely positioned to provide an understanding of the properties of biologics in the solid-state or as liquid formulations, which is of critical importance both in the development of the product and for regulatory approval.” About SSCI SSCI, a division of Albany Molecular Research Inc., provides industry leading contract solid-state and analytical testing services and exists to help companies in the pharmaceutical, food, agrochemical, and other chemical industries develop better products and get them to market more quickly. Over the past quarter century, SSCI has provided comprehensive cGMP research and analytical services in the characterization and chemistry of solid materials, with particular expertise in small and large molecules being investigated for pharmaceutical use. As the AMRI’s Center of Excellence for Solid State Chemistry, its offerings include early candidate support services (in vitro analysis, stability, solubility, dissolution, excipient compatibility), solid form screening and polymorph, salt and cocrystal screening, form selection, particle engineering (process development, particle size method development), property improvement, crystallization of difficult materials, process control, biochemical analysis, full analytical chemistry support including method development and validation, intellectual property consulting and litigation support, and related research activities. For more information about SSCI’s biochemistry services, please contact 1-800-375-2179 or visit

Tazi L.M.,Analytical Development | Jayawickreme S.,Analytical Development
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2016

Dextran sulfate is a polyanionic derivative of dextran, produced by esterification of dextran with chlorosulphonic acid. Dextran sulfate with an average molecular weight of 8000. Da can be added to the cell culture to inhibit binding of proteins to cells, increasing cellular growth and productivity. Residual dextran sulfate levels must be monitored during the purification process development to insure clearance. A size-exclusion chromatography based HPLC assay has been developed for the separation and quantitation of dextran sulfate in a highly concentrated purified protein drug substance sample. Trichloroacetic acid (TCA) was used to precipitate the protein and separate the dextran sulfate. Detection and quantitation of dextran sulfate was achieved by post column reaction with dimethylene blue to form a metachromatic complex that absorbs visible light at 530. nm. The quantitation limit (LOQ) was determined to be 1.5 μg/mL dextran sulfate in high concentration protein samples. © 2015 Elsevier B.V.

Zhang J.,Analytical Development | Zhang J.,Drexel University | Burman S.,Drexel University | Gunturi S.,Drexel University | Foley J.P.,Drexel University
Journal of Pharmaceutical and Biomedical Analysis | Year: 2010

A capillary sodium dodecyl sulfate gel electrophoresis (cSDS) method has been developed and qualified for purity and impurity analysis of monoclonal antibodies. This method was optimized and qualified for the analysis of monoclonal antibody (mAb1) under reduced and non-reduced conditions.Some of the sample preparation parameters including sample buffer pH, incubation temperature and duration, alkylation conditions with iodoacetamide (IAM), and reduction conditions with 2-mercaptoethanol (2-ME) were optimized. It was observed that under slightly acidic conditions (pH 5.5-6.5) the thermally induced fragmentation of non-reduced mAb1 was greatly decreased. As such, a citrate-phosphate buffer at pH 6.5 was used for sample preparation to replace the original Beckman sample buffer (pH 9.0). The optimal sample preparation conditions were found to be as follows: (1) incubation temperature and duration (reduced and non-reduced), 65°C for 5. min; (2) alkylation condition, 10μL of 0.25. M IAM; (3) reduction condition, 10μL of 5-fold diluted 2-ME.The method was qualified by evaluating specificity, accuracy, precision, limit of quantitation (LOQ), and linearity. The method exhibited no interference from sample buffer matrix. The method was found to be linear, accurate, and precise in the range of 0.25-3.0. mg/mL protein concentration. The LOQ of the method was determined to be 0.02. mg/mL for reduced and non-reduced mAb1. In addition, some aspects of sample stability were examined during qualification. © 2010 Elsevier B.V.

Hart M.,Analytical Development | Acott S.,Sanofi S.A.
ecancermedicalscience | Year: 2010

A one-vial formulation of the chemotherapy agent Taxotere® (docetaxel) is likely to be commercially available in some countries in 2010. Through control of two significant potential risk factors for crystallization - intervention into the infusion bag (by using a one-step technique) and temperature (by use of refrigerated storage) - it was postulated that the risk of precipitation would be reduced and the storage time of Taxotere® increased using the one-vial formulation versus the two-vial formulation. Furthermore, improved convenience and flexibility were anticipated as a result of the easier and quicker preparation associated with the one-vial formulation versus the twovial formulation. The results of the physicochemical stability study presented here indicate that the one-vial formulation is indeed associated with reduced risk of precipitation of docetaxel. Moreover, refrigerated storage has been shown to extend the physical and chemical stability for up to seven days, versus 4 h for the currently approved two-vial formulation and 6 h for the one-vial formulation stored at room temperature. However, only physical and chemical stability have been assessed in this study. Copyright: © the authors; licensee ecancermedicalscience.

Liu S.,Analytical Development | Zang L.,Analytical Development
Analytical Biochemistry | Year: 2016

N-glyco-occupancy and afucoslyation level are two important quality attributes associated with N-glycosylation of therapeutic monoclonal antibodies (mAbs). We report here a fast mass spectrometry-based workflow for quantification of N-glycan site-occupancy and afucoslyation level of mAbs with improved throughput, precision, sensitivity and robustness. This method uses the deglycosylation after the first GlcNAc and inter-chain reduction of the mAbs, followed by liquid chromatography/mass spectrometry (LC-MS) analysis. The entire process can be completed within one hour, which provides a rapid quantitation of N-glyco-occupancy and afucosylation to support high-throughput cell line selection and process development for mAb biopharmaceuticals. © 2016 Elsevier Inc.

PubMed | Cell Culture Development and Analytical Development
Type: Journal Article | Journal: Biotechnology progress | Year: 2016

Chemically defined media have been widely used in the biopharmaceutical industry to enhance cell culture productivities and ensure process robustness. These media, which are quite complex, often contain a mixture of many components such as vitamins, amino acids, metals and other chemicals. Some of these components are known to be sensitive to various stress factors including photodegradation. Previous work has shown that small changes in impurity concentrations induced by these potential stresses can have a large impact on the cell culture process including growth and product quality attributes. Furthermore, it has been shown to be difficult to detect these modifications analytically due to the complexity of the cell culture media and the trace level of the degradant products. Here, we describe work performed to identify the specific chemical(s) in photodegraded medium that affect cell culture performance. First, we developed a model system capable of detecting changes in cell culture performance. Second, we used these data and applied an LC-MS analytical technique to characterize the cell culture media and identify degradant products which affect cell culture performance. Riboflavin limitation and N-formylkynurenine (NFK), a tryptophan oxidation catabolite, were identified as chemicals which results in a reduction in cell culture performance.

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