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laboratoryPharmaceutical & Biotechnology Product Development Services

plantAgrochemical Services

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12.16.2019

Frontage Expanding Geographic Foothold into Canada and the West Coast of North America by Acquisition of BRI

Exton, Pennsylvania - Frontage Holdings Corporation ( “Frontage” or the “Group”, 1521.HK), a contract research organization (“CRO”) providing integrated, science-driven research, analytical and product development services with presence in both the United States and China, today announced 11736655 CANADA LTD., an indirectly wholly-owned subsidiary of the Group through Frontage Laboratories, Inc.("Frontage Labs”), entered into a share purchase agreement with J&J Corporate Services, Inc., an independent third party. According to the agreement, 11736655 CANADA LTD. will purchase all of the outstanding shares of BRI Biopharmaceutical Research, Inc. (“BRI”) owned by J&J Corporate Services, Inc.

BRI is a Contract Research Organization (“CRO”) that was established by its current president and founder, Dr. David Kwok, more than 20 years ago in Vancouver, Canada. BRI is engaged in providing science-driven drug discovery and IND/NDA-enabling studies for pharmaceutical and biotechnology companies.

As a CRO, BRI offers a variety of services to its customer base, including but not limited to bioanalytical assays for measurement of drug candidates, metabolites and biomarkers, in-vitro drug metabolism/ADME, in vivo DMPK/ADME, formulation development, DS/DP stability and analytical CMC assays, and anticancer drug pharmacology assessment.

“Expanding our geographic foothold into Canada and the west coast of North America will allow us to offer our clients proximal access to our DMPK and Bioanalytical Services. It will effectively increase the client base that we currently serves in this specific field, with the potential to increase our revenue generated through these highly specialized services”, said Dr Abdul Mutlib, EVP Frontage DMPK Services, “In addition, the acquisition would extend our current contract research services into human tumor xenograft mouse efficacy models, obesity/diabetes rodent metabolic disease models, and the growing research market in human gut microbiome metabolism and biomarker assays. These services will further complement our current scientific expertise, capabilities and service portfolio to meet the needs of its broad client base.”

“We believe that outsourcing by the pharmaceutical industry is expected to continue to increase in North America and China. upon completion of the acquisition, we will expand our capacity with additional scientists, equipment, and facilities to be used in the provision of existing and novel services to our customers,” said Dr. Song Li, Founder and Honorary Chairman of Frontage, CEO of Frontage Labs, “The combined resources will also enable Frontage to become a global leader in providing DMPK services to our existing and new clients in pharmaceutical and agrochemical industries, and further our goal to establish new centers of excellence in DMPK throughout North America and China.”

About Frontage Holdings Corporation

Frontage Holdings is a fast-growing contract research organization (“CRO”) providing integrated, science-driven research, analytical and development services throughout the drug discovery and development process to enable pharmaceutical companies to achieve their drug development goals. The Company benefits greatly from having operations in both the United States and China - the two largest markets for CRO services in the world and is well placed to capture growth opportunities in both markets.

The Company believes that a “Two Countries, One System” approach differentiates itself from competitors, as it assures customers the same quality standards in both China and the United States, while also providing the company's customers with a detailed and highly experienced understanding of the regulations and requirements for drug discovery and development in both countries. The Company positions itself as a value-add partner with a focus on solving customers' most significant and complex drug discovery and development challenges. The Company's scientific knowledge base, technical expertise and reputation for high quality services have been integral to its ability to enter into strong long-term strategic relationships and partnerships with key customers.

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3.10.2020

Frontage Welcomes Glenn Washer, BSc, DABT as Executive Vice President, Global Safety & Toxicology Services

Frontage Laboratories is pleased to announce that Glenn Washer, BSc, DABT has joined Frontage as our Executive Vice President, Global Safety & Toxicology Services. Glenn will report directly to Dr. Song Li, CEO.Frontage Laboratories is pleased to announce that Glenn Washer, BSc, DABT has joined Frontage as our Executive Vice President, Global Safety & Toxicology Services. Glenn will report directly to Dr. Song Li, CEO.

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5.20.2020

Frontage Announces the Appointment of Michael J. Potchoiba, M.S to Head the QWBA-Center of Excellence in Exton, PA.

Frontage Laboratories, Inc., is pleased to announce the appointment of Michael J. Potchoiba, M.S to head the QWBA-Center of Excellence in Exton, PA.

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5.26.2020

Frontage Laboratories, Inc establishes a QWBA Center of Excellence (COE) in Exton PA

Frontage Laboratories, a contract research organization (“CRO”) providing integrated, science-driven, product development services, has established a Quantitative Whole‑Body Autoradiography (QWBA) Center of Excellence (COE) at our Exton PA facility. 

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Resources

white-paper
The Value Of Robust Exploratory Toxicology Testing Prior To Pivotal GLP Studies

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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CMC Measuring Biological Activity Of Biopharmaceuticals With …

CMC Measuring Biological Activity Of Biopharmaceuticals With …

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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CMC Stability Testing As A Quality Control Measure

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
Validating The Simoa Technology

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
The Use of Modified Rat Vascular Access ButtonsTM to Refine Repeat…

The Use of Modified Rat Vascular Access ButtonsTM to Refine Repeat…

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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Development and Validation of an LC-MS.MS Method for the Simultaneous…

Development and Validation of an LC-MS.MS Method for the Simultaneous…

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

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Overcoming Stability Issues in the Development of an LC-MS/MS Method…

Overcoming Stability Issues in the Development of an LC-MS/MS Method…

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
Quantitation of Myostatin.GDF-8 in Human Serum Using an Enzyme Linked…

Quantitation of Myostatin.GDF-8 in Human Serum Using an Enzyme Linked…

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…

Simultaneous Determination of Coproporphyrin-I and Coproporphyrin-III in…

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

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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Agrochemical

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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Bioanalytical Biomarkers

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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Bioanalytical Large Molecule

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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Bioanalytical Overview

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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Bioanalytical Small Molecule

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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Clinical & Biometrics

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 CTM Manufacturing

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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CMC GMP Analytical Testing

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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CMC GMP

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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CMC Product Development

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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DMPK

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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Drug Safety

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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