Sterile Fill-Finish

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

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.

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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 (DP) development and clinical supply manufacturing for both small molecule and biologics is one of the most critical decisions the sponsor makes on its program. Syngene has proven its ability to consistently provide:

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