Challenges in Protein Product Development: 38 (AAPS Advances in the Pharmaceutical Sciences Series, 38) - Image 1

Price loading...

Springer Challenges in Protein Product Development: 38 (AAPS Advances in the Pharmaceutical Sciences Series, 38)

Name: Challenges in Protein Product Development: 38 (AAPS Advances in the Pharmaceutical Sciences Series, 38)
Brand: Springer

Pharmacy - Dispensing

Price History & Forecast

No Price Data Available

Price history will appear here once data is collected from Amazon.

Price Distribution

No price data available for histogram

Description

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration,solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Product Specifications

Brand: Springer
Format: paperback
ASIN: 3030080528
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 10 January 2019
Listed Since: 09 January 2019

Barcode

No barcode data available

Springer Challenges in Protein Product Development: 38 (AAPS Advances in the Pharmaceutical Sciences Series, 38)

Price History & Forecast

No Price Data Available

Price Distribution

Description

Product Specifications

Barcode

Similar Products You Might Like

Development of Biopharmaceutical Drug-Device Products: 35 (AAPS Advances in the Pharmaceutical Sciences Series, 35)

Development of Biopharmaceutical Drug-Device Products: 35 (AAPS Advances in the Pharmaceutical Sciences Series, 35)

Biopharmaceuticals: Challenges and Opportunities

Wiley - Biological Drug Products: Development and Strategies

Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations: 6 (AAPS Advances in the Pharmaceutical Sciences Series, 6)

Quality by Design for Biopharmaceutical Drug Product Development: 18 (AAPS Advances in the Pharmaceutical Sciences Series, 18)

Quality by Design for Biopharmaceutical Drug Product Development: 18 (AAPS Advances in the Pharmaceutical Sciences Series, 18)

Biopharmaceutics Applications in Drug Development

Development and Manufacture of Protein Pharmaceuticals: 14 (Pharmaceutical Biotechnology, 14)

Surfactants in Biopharmaceutical Development

Development and Manufacture of Protein Pharmaceuticals: 14 (Pharmaceutical Biotechnology, 14)

Development of Biopharmaceutical Parenteral Dosage Forms: 085 (Drugs and the Pharmaceutical Sciences)

Springer Biobetters: Protein Engineering to Approach the Curative

Methods for Structural Analysis of Protein Pharmaceuticals: III (Biotechnology: Pharmaceutical Aspects, III)

Academic Press Biotherapeutics Formulation and Device Management

Stability and Characterization of Protein and Peptide Drugs: Case Histories: 5 (Pharmaceutical Biotechnology, 5)

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Current Applications of Pharmaceutical Biotechnology: 171 (Advances in Biochemical Engineering/Biotechnology, 171)

Current Applications of Pharmaceutical Biotechnology: 171 (Advances in Biochemical Engineering/Biotechnology, 171)

Academic Press Dosage Forms and Formulation Developments Vol 1

CRC Press Therapeutic Peptides and Proteins, 3rd Edition

Springer Continuous Pharmaceutical Processing - AAPS Series 42

Elsevier Biophysical Characterization of Proteins Book