局部产品开发和临床阶段制造

Element是世界公认的设计领导者, 开发和临床生产强大的外用药物产品，具有广泛的治疗适应症，包括小分子和多肽, proteins and oligonucleotides.

Element深厚的科学和监管专业知识, purpose-built laboratories, 设备完善的临床试验生产设施, 对质量和合规的根深蒂固的承诺支持了整个外用药物产品的开发和生产过程. 我们的高技能配方师团队在克服复杂局部配方开发特有的挑战和问题方面经验丰富. 成功开发具有最佳渗透的物理和化学稳定的局部配方需要对物理化学性质有深入的了解, including release characteristics, the composition of the drug-delivery system, and the nature of the drug delivery vehicle.

In addition to facilitating patient compliance, topical products offer a wide range of benefits, 包括易于递送和避免第一次代谢问题的能力. 当内部配制局部产品不切实际或成本过高时, Element拥有先进的仪器和熟练的团队，可以开发和制造各种剂型中最复杂的局部配方, including gels, creams, lotions, ointments, suppositories, emulsions, liquids and other semisolid forms.

Element的设计质量(QbD)方法用于局部产品开发

Element的局部产品开发实验室为各种监管途径提供全面的支持, including investigational new drugs (IND), new drug applications (NDA), and abbreviated new drug applications (ANDA), built upon Quality by Design (QbD) principles. FDA强烈鼓励使用QbD方法, 该机构现在在监管提交文件中寻找QbD成分. 使用QbD方法创建实验设计(DoE)确定制造产品的设计空间. 为工艺参数提供更广泛的设计空间，可以实现更稳健的制造，从而可能减少制造时间, increase product shelf life, or increase batch yields.

When a QbD approach is employed, 将用于开发最终产品的生产过程和制造仪器的理解带入分析研究和开发过程, resulting in a higher quality finished product. QbD formalizes product design, automates testing, and streamlines troubleshooting, 作为完全依赖成品测试的替代方案. 我们的监管和科学专家咨询团队不仅帮助客户理解和实施QbD, but also accelerate speed to market, helping companies launch valuable, safe, 和有效的外用产品，以最可靠和最具成本效益的方式.

QbD components include:

• A quality target product profile (TPP)
• Critical quality attributes (CQAs)
• Critical process parameters (CPPs)
• 药物和赋形剂的关键物质属性
• A control strategy
• 定义测试方法和制造过程的有效设计空间

局部药物开发和临床制造服务

• 目标产品概要(TPP)的开发和支持
• 制剂前研究(赋形剂相容性、溶解度、pH谱)
• Lead formulation selection
• Prototype formulation design and development
• 外用产品设计和配方开发
• 新配方开发或现有配方优化
• 工艺开发，包括关键工艺参数的识别和优化
• 工艺验证和工艺性能确认(PPQ)批
• Analytical and microbiological development
• In-process and finished product release testing
• R&D and ICH stability studies
• 包装和容器/封闭的兼容性和完整性测试
• IVRT(体外释放试验)和IVPT(体外渗透)研究
• 实验室规模，中试和临床试验材料制造
• Trial runs on new products
• Packaging and labeling
• Technology transfer and scale-up support
• 技术和法规文件的开发

Processing and production capabilities

• Controlled substances (Schedules I-V)
• High and low shear homogenization
• Semi-automated vial, bottle, and tube filling
• Temperature controls
• Variable speed mixing
• Double-sided agitation
• Blending and granulation
• cGMP batch sizes (1 to 20 L)

The Element advantage

Elementim体育平台app下载领先的配方师团队不断解决高度复杂和具有挑战性的项目, including the formulation of topical gels, creams, emulsions, foams and sprays. 许多因素可以影响半固体和局部制剂的稳定性和功效, including mixing method, temperature, time, heat and cooling rate. 我们的实验室配备了设备，使我们能够对这些因素进行精确控制, 使我们能够开发出最佳的制造工艺. Additionally, 一些活性药物成分(api)会受到环境因素的影响, including UV light and oxygen. Element公司的科学家有技术专长来开发安全的, effective, 和稳定的局部配方，规避潜在的降解挑战.

无论您是计划制定一个全新的局部产品或只是需要简化您目前的生产过程, Element has the deep bench strength, technical breadth, and experience to help. 欲了解更多有关Element的专题产品开发服务或要求报价，请 contact us today.