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Protagen Protein Services GmbH: CRO analítica líder global
A Protagen Protein Services (PPS) é uma CRO analítica líder global e especialista reconhecida em serviços analíticos em ciência de proteínas. A empresa oferece uma ampla gama de serviços para apoiar o desenvolvimento de produtos biofarmacêuticos, biossimilares e dispositivos médicos. Com mais de 20 anos de experiência em análise de proteínas, a PPS se estabeleceu como um parceiro confiável para empresas farmacêuticas e de biotecnologia em todo o mundo.
A PPS oferece soluções analíticas abrangentes que abrangem todos os estágios do desenvolvimento de medicamentos, desde a descoberta até a comercialização. A expertise da empresa reside na caracterização e controle de qualidade de proteínas, incluindo anticorpos monoclonais, proteínas de fusão, biespecíficas, conjugados anticorpo-droga (ADCs) e outras moléculas complexas. A PPS também oferece soluções personalizadas sob medida para atender às necessidades específicas do cliente.
As instalações de última geração da empresa estão equipadas com tecnologias de ponta, como espectrometria de massa, cromatografia líquida (LC), eletroforese capilar (CE), ressonância plasmônica de superfície (SPR) e interferometria de camada biológica (BLI). Essas tecnologias permitem que o PPS forneça dados de alta qualidade com tempos de resposta rápidos.
A PPS tem uma equipe de cientistas altamente qualificados, especialistas em ciência de proteínas. Eles têm uma vasta experiência no desenvolvimento e validação de métodos analíticos para vários tipos de proteínas. A equipe trabalha em estreita colaboração com os clientes para entender seus requisitos e fornecer soluções personalizadas que atendam às suas necessidades.
A PPS está empenhada em fornecer serviços de alta qualidade que cumpram as diretrizes regulatórias, como GMP/GLP/GCP/ISO 9001/ISO 13485/ISO 17025. O sistema de gestão de qualidade da empresa garante que todos os processos sejam bem documentados, controlados, monitorados e melhorado continuamente.
Além de seus principais serviços analíticos, a PPS também oferece serviços de consultoria em tópicos relacionados a proteínas, como desenvolvimento de formulações, estudos de estabilidade, estudos de comparabilidade entre produtos inovadores e biossimilares e suporte regulatório. A equipe de consultoria da empresa é formada por especialistas com ampla experiência na indústria biofarmacêutica.
A PPS tem uma base global de clientes que inclui pequenas startups, empresas de biotecnologia de médio porte e grandes empresas farmacêuticas. A empresa concluiu com sucesso mais de 1.000 projetos para clientes em todo o mundo.
Em resumo, a Protagen Protein Services GmbH é uma CRO analítica líder global que fornece soluções analíticas abrangentes para ciência de proteínas. Com suas instalações de última geração, cientistas experientes e compromisso com a qualidade, a PPS é uma parceira confiável para empresas farmacêuticas e de biotecnologia em todo o mundo.
protagenproteinservices.com
