Our service offerings:

Biologic drug
product development

• Developmental stability evaluation

  Developmental stability evaluation

  Stress study

  Formulation robustness evaluation

• Toxicological dilution and clinical in-use stability evaluation

  Toxicological dilution stability

  Clinical compatibility and stability study

• Technology transfer and process characterization

  Lyophilization process development

  Filling process development

  Process robustness characterization

• Early-stage developability evaluation

  Developability studies

• Drug product development

  Formulation buffer system

  Excipient screening

  Formulation verification

• Filling and lyophilization process development

  Filling process development and transfer

  Lyophilization process transfer

• Packaging material selection/evaluation

  Packaging material screening

  Container integrity testing

  Compatibility verification

Service Advantages:

• · Supports development of various conventional and challenging dosage forms, such as liquid and lyophilized products, multi-dose nasal spray, high-concentration liquid, etc.

  · Covers various routes of administration, such as intravenous injection, subcutaneous/intramuscular injection, intranasal delivery, etc.

  · Covers diverse molecular modalities, such as mAbs, bsAbs, fusion proteins, drug conjugates (ADCs, RDCs, AOCs, etc.), mRNA-LNPs, etc.

  · Supports development at various stages, including pre-clinical phase, IND filing, clinical phases, and BLA filing

•   · Over 10 years of experience in biotherapeutics DP development