寡核苷酸（OGN）治疗因有望治愈疾病而日益被认为是一种重要的治疗方式。但是，与大多数生物疗法不同，OGN药物的开发通常需要在多种复杂的生物基质（例如血液和组织）中以高度的敏感性和特异性进行测定，以测量其暴露量和分布，以低估PK，PD和安全性。

在Frontage Laboratories，我们已经开发出了高度灵敏和特异性的定量方法，使用杂交免疫测定法和LC-MS技术测定血浆和组织中的OGN。在本网络研讨会中，我们将介绍OGN定量方法的开发，验证和这些技术的比较，以及反义寡核苷酸的案例研究。

克服基于寡核苷酸的疗法的生物分析中的挑战及其与临床开发计划的相关性
基因治疗为实际治愈提供了希望。在成为广泛开发的治疗选择之前，这些疗法仍然有许多挑战需要克服。”由Frontage首席商务官Hugh Davis和生物制剂服务副总裁Shaoping Shao主持

由Hugh Davis博士主持的生物分析，讨论基因疗法

当细胞是药物时：前沿实验室专家兼生物制剂服务副总裁邵卫平博士主持的细胞与基因治疗小组讨论。

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.

方达医药是提供一体化、科学驱动的研究、分析和开发服务的CRO。凭借近20年的经验，我们已成功地协助我们的客户在药物开发过程中推进了数百种化合物的研发。

我们是一家CRO公司，在整个药物发现和开发过程中提供一体化的科学驱动的研究，分析和开发服务，以使生物制药公司能够实现其药物开发目标。我们已经使许多创新，通用和消费者健康公司各具规模，可以在全球市场上提交IND，NDA，ANDA，BLA和505（b）（2）申报，从而为患者成功开发重要的疗法和产品。我们致力于提供严格的科学专业知识，以确保最高的质量和合规性。我们已经成功地协助客户通过开发将数百种分子推进全球市场。

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.

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.

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.).

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.

Frontage实验室提供生物分析服务，以帮助支持您的完整药物开发。我们先进的设备和经验丰富的人员将快速有效地为您提供数据以支持您的程序。我们提供具有丰富学术，科学和制药行业经验的高技能，以客户为中心的员工资源。

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.

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.

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.

生物制剂或生物药物本质上比小分子药物复杂。您需要合适的团队来帮助您。前沿拥有复杂的生物制药化合物的分析方法开发，验证和转移所必需的专业知识和最先进的仪器。使用自下而上，中上/下和自上而下的方法，我们为一级，二级和三级结构的表征，翻译后修饰（例如糖基化，二硫键，抗体药物缀合或PEG化）提供了分析支持。

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.

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.

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.

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.