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