Complex Protein Studies Demand Dynamic Techniques
By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.
Proteins must be characterized at many phases of biopharmaceutical research, development, and manufacturing, each with differing demands and requirements. Instrument capabilities-and limitations-influence the speed and success of development efforts. Researchers from biopharma, contract service organizations, and academia face challenges of selecting and optimizing appropriate techniques for protein characterization needs.
Experts interviewed by Pharmaceutical Technology shared similar concerns about the need to conduct complex protein characterization studies under the pressures of tight timelines and urgency to get new drug products to clinic and approval.
Read this article in Pharmaceutical Technology's Bio/Pharma Laboratory Best Practices 2018 eBook.
Article Details
Pharmaceutical Technology
eBook: Bio/Pharma Laboratory Best Practices 2018
Vol. 42
November 2018
Pages: 42–46
Citation
When referring to this article, please cite it as R. Peters, "Complex Protein Studies Demand Dynamic Techniques," Pharmaceutical Technology Bio/Pharma Laboratory Best Practices eBook (November 2018).
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
Inspiration Over Desperation: Accurant Biotech CEO Talks Leadership, Innovation, and Motivation
March 4th 2025Xiao-Yan Cai, PhD, shares insights into her leadership style, the importance of motivation in the workplace, and how she balances repetition with innovation, discussing how hobbies and resilience uniquely shape her professional approach, emphasizing the value of perseverance and preparation in both science and life.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
