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11.4.2019

Frontage Expands DMPK Capabilities by Acquisition of RMI

Frontage Holdings Corporation ( “Frontage” or the “Group”, 1521.HK), a contract research organization (“CRO”) providing integrated, science-driven research, analytical and development services with presence in both the United States and China, today announced Frontage Laboratories, Inc.("Frontage Labs"), a wholly-owned subsidiary of the Group, entered into an equity purchase agreement with Dr. Phillip Tiller and Dr. Xiao (Sean) Yu, two independent third party individuals. According to the agreement, Frontage Labs will purchase the entire equity interest in RMI Laboratories, LLC (“RMI”) owned by the individual third parties.

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10.25.2019

Frontage Holdings expands CMC service in China by raising its shareholding in Frontage Suzhou to 75%

Hong Kong, China. October 25, 2019 - Frontage Holdings Corporation ( “Frontage Holdings” or “the Group”, 1521.HK), a contract research organization (“CRO”) providing integrated, science-driven research, analytical and development services with presence in both the United States and China, today announced Frontage Laboratories (Shanghai) Co., Ltd.("Frontage Shanghai"), an indirectly wholly-owned subsidiary of the Group, entered into the stock transfer agreement with an independent third party individual. According to the agreement, Frontage Shanghai will acquire 25.96% stake in Frontage Laboratories (Suzhou) Co, Ltd. (“Frontage Suzhou”) owned by the individual third party for a cash consideration of RMB 14,433,800. Upon the completion of the Acquisition, Frontage Shanghai will own a 75% stake in Frontage Suzhou. As a result, Frontage Suzhou will become a subsidiary of the Group with an indirect 75% equity. Therefore, Frontage Suzhou’s financial results, assets and liabilities will be consolidated into the Group's financial statements.

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10.1.2019

Frontage Expands Bioanalytical Capacity and Capabilities to Support Biologic Drug Development, Biomarkers and Cell and Gene Therapy

Frontage Laboratories, Inc, a CRO providing integrated, science-driven, product development services, is pleased to announce expansion of their bioanalytical laboratories. The extension of their US bioanalytical laboratories in Exton PA includes an additional 10,000 square feet of laboratory space that will be dedicated to further enhancement of their capabilities in biologic drug development, biomarkers and cell and gene therapy.

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9.11.2019

Frontage Holdings launched a new 42,000 sq.ft. lab in Shanghai, China

Shanghai, Sep 6, 2019 - Frontage Holdings Corporation (“Frontage Holdings” or “Frontage,” stock code: 1521.HK), a Contract Research Organization (“CRO”) providing integrated, science-driven research, analytical and product development services in both the U.S. and China, announced today the opening of a new lab facility in Shanghai, China. 

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8.13.2019

Frontage Clinical Services, Inc. Expands Facilities to Accommodate Tobacco and Nicotine-Related Studies

Frontage Clinical Services, Inc. (“Frontage Clinical”), an associate of Frontage Laboratories, Inc. (“Frontage Labs”), is pleased to announce completion of renovations to Frontage Clinical’s center in Secaucus, New Jersey, to now accommodate clinical studies on tobacco and nicotine-containing products. This expansion highlights Frontage Clinical’s commitment to the investigation of the safety of new tobacco alternatives.

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Resources

webinar
Webinar: Gene Therapy 2019

Webinar: Gene Therapy 2019

Oligonucleotide (OGN) therapy is increasingly recognized as an important therapeutic modality on the promise of curing diseases. However, unlike most biotherapeutics, the development of OGN drugs often requires their determination with high sensitivity and specificity in multiple and complex biologic matrices such as blood and tissues in order to measure their exposure and distribution for understating PK, PD and safety.

At Frontage Laboratories, we have developed highly sensitive and specific quantitative methods for determination of OGN in plasma and tissues using hybridization immunoassay and LC-MS techniques. In this webinar, we will present the method development, validation and the comparison of these techniques for the quantification of OGN as well as a case study with antisense oligonucleotides.

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expert-interview
Expert Interview: Gene Therapy

Expert Interview: Gene Therapy

Overcoming the Challenges in Bioanalysis of Oligonucleotide-based Therapies and Relevance to the Clinical Development Plan
“Gene therapy provides the hope of actual cures. These therapies still have many challenges to overcome before they will become widely developed therapeutic options.” Featuring Frontage's Chief Business Officer, Hugh Davis, and Vice President of Biologics Services, Weiping Shao

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podcast
Podcast: Gene Therapy

Podcast: Gene Therapy

Bioanalysis Zone podcast featuring Hugh Davis, PhD discussing Gene Therapy

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panel-discussion
Panel Discussion: Gene Therapy

Panel Discussion: Gene Therapy

When the Cell is the Drug: Cell and Gene Therapy Panel Discussion featuring Frontage Laboratories expert and Vice President of Biologics Services, Dr. Weiping Shao.

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white-paper
AdobeStock 182073532 60x78 - White Paper: The Value Of Robust Exploratory Toxicology Testing Prior To Pivotal GLP Studies

White Paper: The Value Of Robust Exploratory Toxicology Testing Prior To Pivotal GLP Studies

Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21 percent in 2013. In other words, “efforts to remove unsafe agents earlier in the development cycle are paying off.” Much of this success in small molecules relates to careful and methodical work done well before the Investigational New Drug (IND) application.

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white-paper
Frontage Lab Cell- Based Assay

White Paper: CMC Measuring Biological Activity Of Biopharmaceuticals With Cell-Based Assays

The biological activity of biopharmaceutical compounds (such as peptides, monoclonal antibodies, growth factors, and cytokines) has a direct bearing on their potency, which is a critical quality
attribute and a representation of efficacy. For biopharma companies,
measuring a cell’s bioactivity is important when:
• Screening compounds to develop the lead candidate;
• Validating potency when applying for regulatory approval;
• Confirming that the biological characteristics of the productremain consistent throughout the development cycle andfrom lot-to-lot, or site-to-site;
• Controlling for a compound’s quality prior to productrelease (either for a clinical trial or commercialization);
• Testing for stability; and
• Demonstrating biosimilarity between a biosimilar and theoriginator compound.

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white-paper
stability testing frontage laboratories

White Paper: CMC Stability Testing As A Quality Control Measure

Stability testing is, in essence, a quality control process and is therefore a vital component of every phase of clinical development for both large and small molecules – from early phase through to and including post approval. It should be treated as an ongoing program rather than as a periodic exercise.

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white-paper
Frontage Simoa

White Paper: Validating The Simoa Technology

Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and Liquid Chromatography-Mass Spectrometry (LC-MS) for example—are automated. Thus, they are controlled by complex computer systems, and the information they generate is stored electronically. If these systems are to be used in regulated research studies in the US, EU, and Japan, the instruments themselves must be qualified and their supporting software and processes must be validated as meeting regulatory requirements.

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poster
Frontage Laboratories Pig Port Poster 60x78 - Poster: The Use of Modified Rat Vascular Access ButtonsTM to Refine  Repeat Blood Sample Collection in Miniature Pigs

Poster: The Use of Modified Rat Vascular Access ButtonsTM to Refine Repeat Blood Sample Collection in Miniature Pigs

Pigs share many physiological, anatomical, and metabolic similarities to humans making them a great model. Recently, there has been an increased demand to use miniature pigs as a non-rodent species for pharmacology and toxicology studies as part of pre-clinical drug safety testing. Typically, these tests require more than 8 blood collection time points over a 24 hour period and the same pig may be used to evaluate multiple dose levels or for multiple studies resulting in many blood collections per animal. Additional blood vessel access may also be required for test articles administered intravenously (IV).

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poster
Frontage Laboratories Poster Development and Validation of an LC MS.MS Method for the Simultaneous Quantitation of Fifteen Bile Acids in Human Serum 60x78 - Poster: Development and Validation of an LC-MS.MS Method for the Simultaneous Quantitation of Fifteen Bile Acids in Human Serum

Poster: Development and Validation of an LC-MS.MS Method for the Simultaneous Quantitation of Fifteen Bile Acids in Human Serum

Development and Validation of an LC-MS.MS Method for the Simultaneous Quantitation of Fifteen Bile Acids in Human Serum

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poster
Overcoming-Stability-Issues-in-the-Development-of-an-LC-MS.MS-Method-for-the-Quantitation-of-Azacitidine-in-Human-Plasma

Poster: Overcoming Stability Issues in the Development of an LC-MS/MS Method for the Quantitation of Azacitidine in Human Plasma

Overcoming Stability Issues in the Development of an LC-MS/MS Method for the Quantitation of Azacitidine in Human Plasma

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poster
Poster: Quantitation of Myostatin.GDF-8 in Human Serum Using an Enzyme Linked Immunosorbent Assay (ELISA)

Poster: Quantitation of Myostatin.GDF-8 in Human Serum Using an Enzyme Linked Immunosorbent Assay (ELISA)

Poster: Quantitation of Myostatin.GDF-8 in Human Serum Using an Enzyme Linked Immunosorbent Assay (ELISA)

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poster
Simultaneous Determination of Coproporphyrin I and Coproporphyrin III in Human Plasms and Human Urine Using LC MS.MS  60x78 - Poster: Simultaneous Determination of Coproporphyrin-I and Coproporphyrin-III in Human Plasms and Human Urine Using LC-MS/MS

Poster: Simultaneous Determination of Coproporphyrin-I and Coproporphyrin-III in Human Plasms and Human Urine Using LC-MS/MS

Simultaneous Determination of Coproporphyrin-I and Coproporphyrin-III in Human Plasms and Human Urine Using LC-MS/MS

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fact-sheet
tobacco frontage laboratories clinical research

Fact Sheet: Tobacco

With over 20 years of experience in execution of comprehensive Phase I-IIa studies, Frontage Clinical Services has full capabilities to conduct a broad range of study types (e.g. PK, confinement and ambulatory) in support of tobacco related studies. With extensive expertise in a wide variety of delivery systems, we are well-positioned to conduct tobacco-focused clinical research studies.

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fact-sheet
Field SMALL 60x78 - Fact Sheet: Agrochemical

Fact Sheet: Agrochemical

Frontage Laboratories provides extensive support to clients in the Agrochemicals industry. Our broad service offering includes biological, chemical, and regulatory support in a GLP-compliant facility.

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fact-sheet
Small Molecule 1 60x78 - Fact Sheet: Bioanalytical Biomarkers

Fact Sheet: Bioanalytical Biomarkers

Frontage’s Bioanalytical Team is highly experienced in developing, qualifying and validating Biomarker assays. We have expertise in ELISA, ECL based platforms as well as ultra-sensitive detection capabilities (Quanterix SimoaTM) for quantitation in the femtogram/mL range including single and multiplex analysis in various disease categories (e.g. Inflammation, Oncology, Neuroscience, Infectious Diseases, Respiratory, etc.).

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fact-sheet
BioA Scientists

Fact Sheet: Bioanalytical Large Molecule

Gain access to comprehensive biologics services in support of advanced development programs with Frontage’s bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation.

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fact-sheet
bio 60x78 - Fact Sheet: Bioanalytical Overview

Fact Sheet: Bioanalytical Overview

Frontage Laboratories provides bioanalytical services to help support your full drug development. Our state-of-the-art equipment and experienced personnel will quickly and efficiently provide you with the data to support your programs. We provide the resources of a highly skilled, client- focused staff with extensive academic, scientific and pharmaceutical industry experience.

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fact-sheet
BioA Scientists

Fact Sheet: Bioanalytical Small Molecule

Frontage’s experienced staff and state-of-the-art instrumentation delivers data you can trust. Count on Frontage Laboratories for reliability. From method development or transfer and validation to sample analysis and reporting, Frontage’s bioanalytical team has earned a reputation for consistent and high-quality delivery, project after project. Our bioanalytical expertise extends to combined small and large molecules such as protein, antibody, antibody drug conjugates as well as biomarker analysis for small molecule drug candidates.

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fact-sheet
Clinical 10 2 60x78 - Fact Sheet: Clinical & Biometrics

Fact Sheet: Clinical & Biometrics

Frontage’s clinical teams have set new standards for rapid start-up and efficient study conduct. Our experienced staff provides study management services for all phases of clinical research, including study design, protocol and ICF development, IRB submission, study execution, data management, pharmacokinetic/pharmacodynamic analysis, programming, biostatistics, and medical writing, to take each study from start to finish.

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fact-sheet
CMC Prod Dev

Fact Sheet: CMC CTM Manufacturing

For early phase clinical trial materials, choose a product development team focused on scalability and performance. Ensure comprehensive product analysis with Frontage’s team of experienced analytical scientists.
Frontage brings

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fact-sheet
CMC 04 60x78 - Fact Sheet: CMC GMP Analytical Testing

Fact Sheet: CMC GMP Analytical Testing

Biologics or biopharmaceuticals are inherently more complex than small-molecule drugs. You need the right team to help you. Frontage has expertise and state of the art instrumentation necessary for the analytical method development, validation and transfer for complex biopharmaceutical compounds. Using bottom up, middle up/down, and top down approaches, we offer analytical support for characterization of primary, secondary and tertiary structures, post translational modifications such as glycosylation, disulfide linkage, antibody drug conjugation, or PEGylation.

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fact-sheet
CMC GMP

Fact Sheet: CMC GMP

Ensure comprehensive product analysis with Frontage’s team of experienced analytical scientists. We specialize in analytical method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing support, as well as commercial product release and stability testing. Our services are designed to help sponsors throughout the drug development process in their effort to fully characterize drug substances, developmental formulations and commercial drug products.

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fact-sheet
CMC 04 60x78 - Fact Sheet: CMC Product Development

Fact Sheet: CMC Product Development

Frontage’s CMC portfolio of services spans drug product development, analysis, delivery and supply, from proof-of-concept, preclinical stages through Phase III clinical trials and commercialization support. With proven success in developing drug products for novel, generic and consumer products, we focus our efforts on clients’ specific needs. Our formulation development experience and capabilities cover a wide range of dosage forms at IND, NDA, ANDA and 505(b)(2) project stages and applications.

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fact-sheet
DMPK 4 60x78 - Fact Sheet: DMPK

Fact Sheet: DMPK

DMPK studies can provide critical data during discovery and development of pharmaceutical and agrochemical products. Frontage’s DMPK services, performed in accredited facilities, can help support lead drug candidate or chemical selection, or help you meet specific regulatory requirements.

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fact-sheet
nonrodent 60x78 - Fact Sheet: Drug Safety

Fact Sheet: Drug Safety

Frontage Laboratories provides drug safety services to guide new therapies from discovery to full development support. Our extensive profile of IND enabling pivotal studies support swift progression of your lead compounds into the clinic – streamlining your development process. We provide the resources of a highly skilled, client-focused staff with extensive academic, scientific and pharmaceutical industry experience.

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