製剤化と最終充填を確実に成功させる

関連資料

• Low NPI Sucrose for Biopharmaceutical Formulations

  Read about a purification process resulting in low-NPI sucrose to achieve more stable protein formulations.

• Addressing Viscosity Challenges for Subcutaneous Injections

  It was found that in contrast to single excipients, an amino acid and an anionic excipient can be more efficient at reducing viscosity when used in combination than when either is used alone, even at higher concentrations.

• White Paper: The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation

  Read about the effect of protein viscosity on injection force and the platform’s ability to balance viscosity reduction with protein stability.

• Parenteral Drugs: Ensuring Sterility and Minimizing Risks During Manufacturing

  This article describes strategies to ensure sterility of parenteral drugs.

• Formulation Product Finder

  Quickly sort our excipients and API portfolio by dosage form, application, and many other parameters.

• Risk Mitigation Tool

  Get guidance through the challenges and quality requirements of your bio-manufacturing process.

• Brochure: Millipak^® Final Fill Filters Reduce Contamination Risks and Simplify Filtration System Design and Operation

  This tech note summarizes the results of microbial challenge studies that confirm the aseptic multipurpose port (AMPP) prevents microbial contamination entering the flow path.

• Brochure: Identifying Appropriate-Quality Raw Materials in an Evolving Regulatory Environment

  Manufacturers need to ensure that the raw materials they use meet regulatory requirements and can be demonstrated to have appropriate, consistent and documented quality that mitigates risk and is traceable throughout the supply chain.

• Use of Stabilizers and Surfactants to Prevent Protein Aggregation

  This article outlines critical factors in long-term stability of proteins, and manufacturing conditions and drug product handling.