BioAnalytical

Bio Analytical

Analytical method development plays a pivotal role in ensuring the quality, safety, and efficacy of therapeutic products. At APC, our Analytical Process Development services are tailored to deliver comprehensive analytical solutions that empower our clients to make informed decisions at every stage of the development process of their large molecule medicines across different modalities.

Advanced BioAnalytical Capabilities

Our cutting-edge analytical infrastructure is equipped with advanced instrumentation and methodologies, providing comprehensive support for the development of biologics across various modalities. From chromatography and spectroscopy to mass spectrometry and microscopy, our capabilities cover every aspect essential for biologic development. This includes specialized tools for protein characterization, potency assays, impurity analysis, stability studies, formulation development, viral safety testing, and regulatory-compliant analytical methods tailored specifically for biologics.

Method Development and Validation:

Our experienced team of analytical scientists specializes in method development and validation across a wide range of analytical techniques. Whether it's developing new analytical methods or validating existing ones, we ensure robustness, accuracy, and compliance with regulatory standards, enabling reliable and reproducible analytical results.

Stability Studies and Characterization

Stability studies are critical for assessing the long-term stability and shelf-life of biopharmaceutical products. We offer comprehensive stability testing services, including forced degradation studies, accelerated stability testing, and real-time stability monitoring, to evaluate the physical, chemical, and microbiological stability of drug substances and products.

Impurity Profiling and Quantification

Detecting and quantifying impurities is essential for ensuring the safety and quality of pharmaceutical products. Our analytical experts specialize in impurity profiling and quantification using advanced chromatographic and spectroscopic techniques, allowing for the accurate identification and quantification of impurities at trace levels.

Regulatory Support and Compliance

We understand the importance of regulatory compliance in the pharmaceutical industry. Our Analytical Process Development team is well-versed in regulatory requirements and guidelines, including ICH, FDA, and EMA regulations. We provide comprehensive support for regulatory submissions, including preparation of analytical methods, validation reports, and regulatory documentation.

Collaborative Approach

At APC, we believe in a collaborative approach to BioAnalytical Process Development, working closely with our clients to understand their unique analytical challenges and objectives. Whether it's routine testing, method development, or troubleshooting analytical issues, we strive to deliver tailored solutions that meet the specific needs of each project.