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        SynVent is Syngene’s platform for fully integrated therapeutic discovery and development across large and small molecules. 

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Sterile Fill-Finish

Integrated partner for clinical and small- scale commercial supplies—small molecules and biologics

The demand for sterile fill-finish services has outpaced available capacity, leading to extended wait times and delayed clinical trials for sponsors. In response to this demand, Syngene has set up a state-of-the art Sterile Fill-Finish facility, building upon years of sterile fill formulation expertise to develop and manufacture:

  • Sterile products in pre-filled syringes
  • Sterile products in pre-sterilized vials

Syngene’s Sterile Fill-Finish facility is custom-built to meet market demand for small-scale, sterile drug products having short development timelines. Our facility offers drug substance (DS) and drug product (DP) development  and manufacturing for both small molecules and biologics.

Play Video about Syngene’s-Sterile-Fill-Finish-Facility

Syngene’s Sterile Fill-Finish facility is custom-built to meet your company’s clinical and small-scale commercial needs.

The Syngene advantage

Deciding on a partner for drug product development and clinical supply manufacturing is one of the most critical decisions for any sponsor. Syngene assures you of the following:

  • Integrated formulation and analytical services to reduce timelines and overall costs for clinical programs from IND to registration
  • In-depth experience handling biologics and small molecules as well as products that are sensitive to light, temperature or oxygen
  • Expertise in technology transfer and trouble-shooting during batch manufacturing and successful completion of cGMP batches
  • Robust quality management systems and efficient data processing tools for high-quality data on time and in budget
  • A consultative, fit-for-purpose service for critical decisions at each stage of development
  • Collaborative, solution-oriented approach to solve complex problems in CMC services
  • Program management support to keep internal teams aligned on deliverables and timelines and our sponsors well-informed on progress

Process flow

Our sterile formulation development experience

We are a full value chain CDMO partner to global biopharma

  • End to end services from GLP-Tox batches to clinical supplies, process scale up and cGMP manufacturing of sterile drug products for biologics and small molecules
  • Ability to seamlessly integrate between DS development, DP development and cGMP manufacturing of both DS and DP

Syngene offers more than just fill/finish of sterile injectables. Strong technical capabilities and broad parenteral resources help us align with your company’s clinical/commercial objectives and our shared goal of “putting science to work”

Brochure: Sterile Fill-Finish facility: Your integrated partner for customized clinical supplies

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