WEBINAR: Pre-existing antibodies within clinical samples: How does this affect immunogenicity outcomes?
10.19.2017 - 10.19.2017

WEBINAR: Pre-existing antibodies within clinical samples: How does this affect immunogenicity outcomes?

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News Frontage announces that Dr. Philip Doren has joined Frontage as the President of Clinical Services
3.15.2017

Frontage announces that Dr. Philip Doren has joined Frontage as the President of Clinical Services

Today, Frontage announces that Dr. Philip Doren has joined Frontage as the President of Clinical Services. He will help Frontage to evaluate and secure early clinical and biometric opportunities and develop relationships with strategic partners to expand our services in key areas of support.
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Webinar WEBINAR: Outsourcing Analytical Testing for Biologics from a CRO point of view!
8.31.2017

WEBINAR: Outsourcing Analytical Testing for Biologics from a CRO point of view!

Biologics are large molecules with inherently complex structural heterogeneity. Thus, the analytical tests to support CMC (Chemical, Manufacturing and Controls) activities of biologics need to be highly sophisticated to reveal the multifaceted quality attributes. As biopharmaceutical companies are increasingly outsourcing analytical testing to CROs (contract research organizations), the paradigm has shifted for CROs from merely being a pair of extra testing hands to problem-solvers. The new trend is driving CROs to hire top-tier scientists to provide expert solutions for clients with in-depth characterization of the quality attributes. This analysis is performed using cutting edge technologies for structural elucidation, post-translation modification, and degradation pathways, etc. In the meantime, the modalities of biologics are becoming more and more complex, such as antibody drug conjugates, PEGylated proteins, conjugate vaccines, fusion proteins, and gene and cell based therapies. In light of this complexity, biopharmaceutical and biotech companies are demanding innovative and creative solutions from CROs.

The advent of revolutionary technologies offers new instruments to advance analytical science. Many analytical methods are rapidly evolving. For example, high-resolution mass spectrometry enables top-down, or middle-down approaches to characterize structure and modification of the macromolecules, in addition to traditional bottom-up peptide mapping; the workflow for N-linked glycan analysis is integrated with highly active PNGase F and a novel probe for both fluorescence and mass detection, while new endoglycosidase for O-linked glycan is becoming commercially available; capillary electrophoresis is replacing traditional slab gel for SDS-PAGE, IEF and Western blotting. Advances in instrumentation for surface plasmon resonance (SPR) and bio-layer interferometry (BLI) techniques make it feasible for routine testing of receptor binding kinetics. In addition, the Solo VPE technologyenables direct and neat determination of protein concentration without the need for sample dilution and thus received rapid acceptance in the biopharmaceutical industry when it was introduced.

At the center of the field, regulatory agencies have provided specific guidelines for large molecule analytical testing. In the "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" document, the US Food and Drug Administration (FDA) requires that "a precise and thorough characterization of antibody structural integrity, specificity, and potency should be conducted and described in the IND." While the guidance pertained specifically to monoclonal antibody products for human use, it can be applied to all other biologics in general. In July 2017, FDA issued the guidance for "Analytical Procedures and Methods Validation for Drugs and Biologics", which complements the International Conference on Harmonisation (ICH) guidance Q2(R1), "Validation of Analytical Procedures: Text and Methodology Q2(R1)" for developing and validating analytical methods. The guidance provided general requirements for analytical procedure development and validation using statistical tools, for example, analysis of variance (ANOVA) to assess regression analysis.

In response to the demand from biopharmaceutical and biotech companies, as well as the regulatory agencies, CROs also need to modernize the analytical capabilities to support clients and solve the most challenging problems for large molecules, as well as provide service for release and stability testing. This webinar will provide the audience with a general explanation of how CROs can support biologics testing, ranging from product release and stability to in-depth structural elucidation and degradation pathway studies.

Click here for More Information: http://xtalks.com/Outsourcing-Analytical-Testing-Biologics-CRO.html
Click here to REGISTER: https://register.gotowebinar.com/register/1041119148838122243
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Convention Contract Pharma
9.14.2017 - 9.15.2017

Contract Pharma

The 16th Annual Contracting & Outsourcing Conference & Tabletop Exhibition will be held September 14-15, 2017 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 14th provides the perfect venue for easy, informal discussions for manufacturing, packaging, laboratory services and more! The tabletop exhibition will be held one day only on Thursday, September 14th with an additional half day of sessions held on Friday, September 15th.
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News
5.19.2016

Frontage Bioanalytical Labs go Paperless

Boston, US & London, UK, May 19, 2016 – Frontage Laboratories, a full-service contract research organization (CRO) with labs in the United States and China, has selected IDBS E-WorkBook 10 to be deployed across its laboratory facilities. In addition to serving as the global electronic lab notebook (ELN), the Pennsylvania-based bioanalytical (BA) laboratory is implementing the IDBS BA solution as its lab execution system. These workflow configurations will ensure end-to-end compliance, quality, and traceability across the GLP laboratory.
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News
6.15.2016

Frontage becomes the first CRO to complete GLP validation on Simoa HD-1 Analyzer for Biomarker Analysis

Frontage Laboratories, Inc., a Contract Research Organization based in Pennsylvania, New Jersey and China, today announced that they are the first CRO to complete a GLP validation of the Simoa HD-1 Analyzer and software along with the interface to Watson LIMS. Data will be generated, processed and stored in a secure environment meeting the compliance requirements needed to support biomarker analysis for regulated studies.
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News
10.13.2015

Frontage Expands Service Offerings to Agrochemical Companies

Exton, PA – October 13, 2015 – Frontage, a full service contract research organization (CRO), today announced that it has expanded its service offerings to agricultural chemical companies engaged in developing products that are covered by FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) and regulated by the United States Environmental Protection Agency (EPA). The EPA recently completed an inspection of the Frontage’s Exton, Pennsylvania facility on September 3, 2015 with no deficiencies identified. The key services now offered to agrochemical companies include pharmacokinetic evaluations of new candidates, metabolism and mass balance studies using radiolabeled compounds, residue assessments, analytical method development/validation and stability evaluations.
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Convention GPhA Fall Technical 2017
11.6.2017 - 11.8.2017

GPhA Fall Technical 2017

The Association for Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association (GPhA), is the nation’s leading trade association for manufacturers and distributors of generic prescription drugs, manufacturers of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.
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News
9.29.2015

Frontage Doubles Bioanalytical Lab Capacity

Frontage, a full service contract research organization (CRO) located in the USA and China, is pleased to announce the expansion of its bioanalytical laboratories to meet increased demand for its services from existing and new biopharmaceutical clients.
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Convention AAPS Annual Meeting 2017
11.12.2017 - 11.15.2017

AAPS Annual Meeting 2017

The 2017 AAPS Annual Meeting and Exposition programming will focus on five themes:

Advanced Formulation Characterization Approaches
Patient-Centered Innovations in Healthcare Technology
Products for Pediatrics: It’s Not Child’s Play
Improving Inter-organization Collaboration
Cancer Moonshot: Emerging Modalities for Oncology

Each theme will spotlight a keynote speaker expected to outline the broad goals of the thematic programming and identify key scientific areas that will be addressed during the meeting.
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