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We know that to attract the best candidates we have to provide a stimulating and challenging work environment that gives our employees the opportunity to meet their career goals. We also recognize the need to offer a competitive benefits package for our employees and their families.

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8.31.2020

Frontage Holdings Announces 2020 Interim Results

Since March 2020, the number of COVID-19 cases continued to rise in the United States, which negatively affected the Group’s business. The global pandemic has limited the full capacity of the Group’s employees performing laboratory services and lowered its delivery efficiency. The Group has employed various mitigation measures focusing on the safety and well-being of its employees, customers and partners, and the continuity of its business operations to minimize the adverse impact of the pandemic. The Group’s facilities in the United States continue to operate at a reduced utilization rate.

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8.26.2020

Dr. Daniel Tang joins Frontage Laboratories, Inc. as Senior Vice President of Bioanalytical and Biologics Services.

Dr. Daniel Tang joins Frontage Laboratories, Inc. as Senior Vice President of Bioanalytical and Biologics Services.

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8.31.2020

Frontage announces the appointment of Dr. Yining Qi as Executive VP of Frontage Laboratories, Inc and President of Frontage Greater China.

Frontage is pleased to announce the appointment of Dr. Yining Qi as Executive VP of Frontage Laboratories, Inc. and President of Frontage Greater China. Dr. Qi has nearly 30 years of experience in research and development leadership and overseeing operations in the regulated pharmaceutical industry. In this role, Dr. Qi will be responsible for the overall leadership and strategic growth of Frontage Greater China operations.

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7.7.2020

Frontage expands synthetic & medicinal chemistry and process research & development services by acquisition of ACME Bioscience

ACME provides discovery chemistry, medicinal chemistry, process chemistry research & development, and chemical manufacturing services for worldwide biopharmaceutical companies.  ACME has extensive experience in antiviral and anti-bacterial research, along with expertise in nucleotides, nucleosides, triphosphates pro-drugs, heterocycles, and boron containing compounds, and has partnered with many customers in developing new chemical entities.

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Resources

podcast
NOAEL in IND Programs

NOAEL in IND Programs

Throughout my career as a toxicologist, I have observed that toxicology studies in drug development, are sometimes considered as being only a box-checking exercise on the path to the clinical trial. While this can be so in a limited respect, I think it is underappreciated that definitive toxicology studies, and related studies, serve a highly critical purpose. That is, they help identify potential safety issues and target organs in humans, to identify translational markers of potential toxicity in later human trials and most immediately and importantly they can provide high quality and reliable data on which to base the safe starting dose in humans. Without these definitive studies, or with poorly conducted or interpreted studies, the risk to trial participants and to eventual patients, is simply too high. So, the data from these studies, and particularly the NOAEL information is essential for the safe and effective development of new drugs.

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podcast
Common Errors in IND-enabling toxicology programs

Common Errors in IND-enabling toxicology programs

5-common errors in designing & managing IND-enabling toxicology programs with special guest: Glenn Washer, EVP of Global Safety and Toxicology at Frontage Laboratories, Inc.

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podcast
Developing HCPs ELISA assay for biopharmaceutical products

Developing HCPs ELISA assay for biopharmaceutical products

Tips for developing residual host cell proteins (or HCPs) ELISA assay for biopharmaceutical products using commercial kits with special guest: Dr. Jeng-Dar Yang, Vice President of Biologics Development and Manufacturing Services at Frontage Laboratories, Inc.

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podcast
In Vitro BE Study in ANDA Drug Product Development

In Vitro BE Study in ANDA Drug Product Development

Podcast: In Vitro BE Study in ANDA Drug Product Development with special guest: Dr. Kang Wang, Vice President of Analytical Services at Frontage Laboratories, Inc.

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podcast
Sterile Product Development of Poorly Water Soluble Drugs

Sterile Product Development of Poorly Water Soluble Drugs

Delivery Modalities for Sterile Product Development of Poorly Water Soluble Drugs with special guest: Dr. Manish Mujal, Director of Product Development and CTM Manufacturing at Frontage Laboratories, Inc.

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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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white-paper
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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white-paper
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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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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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fact-sheet
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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