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.
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.
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.
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.
Poster: Pre-Existing Antibodies within Immunogenicity Testing
Monoclonal antibodies and next generation molecules such as antibody-drug conjugates (ADC) are being developed and moved into early phase clinical testing. These new molecules bring challenges for measuring immunogenicity within human serum samples.
• Therapeutic monoclonal antibodies could have structural regions which could contain ADA binding domains [Figure 1].
• ADC molecule has a mAb joined to a small drug by a linker region [Figure 2]. This may lead to a highly potent drug which is also a selective binder of a specific tumor antigen; however, the structure may also present a neoepitope to the immune system.
• Development of anti-drug antibody (ADA) assays to both mAb’s and ADC’s very commonly has demonstrated the presence of pre-existing antibodies (PEXA) in a small percentage of drug naïve normal human serum samples. It is currently unclear as to the evolutionary mechanism that has allowed PEXA to develop. Their presence may serve as a regulatory mechanism to suppress the immune system under certain conditions.
• Regardless of how pre-existing antibodies may have developed, measuring an anti-drug antibody (ADA) response in serum samples may present additional challenges with these pre-existing molecules present. Here, we outline a strategy to determine where on the molecule the ADA reactivity is directed against.