Taking GMP manufacturing into the world
GlycoSyn’s bespoke cGMP manufacturing facility is where all areas of the team come together to apply their expertise in complex chemistry, quality assurance, and scaled production to deliver your material to the highest standards.
Commitment to quality is in our every molecule.
We distinguish ourselves with our culture of excellence. We provide all our clients with a high level of compliance and certification, in addition to excellent product quality.
Our purpose-built, fully-compliant 560m2 (6000 ft2) processing facility is here to support the production of clinical-grade materials for our clients. Combined with our tightly integrated quality management system and phase appropriate qualification, we have the right capacity to enable all of your clinical material needs.
Why choose us
PIC/S GMP Pt II, ICH Q7 COMPLIANT
Licensed to manufacture medicines, annually audited by MedSafe
BESPOKE FACILITIES
560 m2 processing facility, hazardous area location (Flameproof), 2 discreet cGMP suites
MANUFACTURING FLEXIBILITY
Milligrams to kilograms, excipient to active pharmaceutical ingredients
REGULATORY SUPPORT
Excellent record management, transparent reporting procedures for quality documentation, unrestricted access to secure cloud based data rooms
Our commitment
We operate under a comprehensive quality management system that employs continuous improvement.
We are licensed to operate under PIC/S PE 009-14 (Part II) (ICH Q7 equivalent) guidelines to deliver clinical active pharmaceutical ingredients (APIs) according to international standards.
We are audited by the New Zealand regulator, MedSafe. Since we started cGMP manufacturing in 2003, these annual regulatory audits have found no critical findings.
We involve and inform our clients along every step of our clinical manufacturing, with a clear protocol for reporting quality documentation as outlined in our quality technical agreement (QTA).
Top class specialist capabilities
Our niche offering is our technical capability to deliver molecules requiring intrinsically complex manufacturing requirements. These include cGMP polymer and cGMP carbohydrate manufacture.
We have specialist capabilities suited to the purification of carbohydrates and polymers. These include:
● Nano and ultrafiltration (UF)/tangential flow filtration (TFF)
● Freeze drying
● Biotage chromatography
Our experience with carbohydrate chemistry means we are well equipped to handle cryogenic reactions and high-pressure conditions at scale for the manufacture of complex, specialty products.
Rigorous quality assurance
True quality assurance is a cultural commitment. Our quality system is based on cGMP practice and is designed to deliver predominantly clinical trial APIs in accordance with ICHQ7 requirements.
A quality cGMP process requires a high level of documentation and traceability. That’s why we have adopted a ‘right first time’ approach to our quality system.
“Part of my job is to analyze historical documentation to ensure we follow decision-making processes accurately and responsibly. Magic often happens in early-stage development projects where much is still to be validated. We have the expertise to pinpoint those unknowns, the systems to record and manage them, and the experience to incorporate the lessons that documentation can teach us.”
Helen Quinn
Quality Assurance Manager, GlycoSyn
Meticulous documentation to support regulatory filings
We understand the importance of documentation as a quality assurance process, ensuring the compounds we make are fit for their intended purpose. We leave nothing to chance. Working in small teams, with oversight from lead senior scientists, we openly and proactively discuss expectations to ensure we deliver the needed level of quality for the required stage of clinical development.
Our quality management system is designed to carefully manage the large volumes of quality documentation required for investigational new drug (IND) submissions. We have excellent record management and can find documents at a moment’s notice. Our clients have unrestricted access to secure cloud-based data rooms to readily access these records.
With these systems in place, we are happy to assist our clients with source document preparation. These documents include but are not limited to:
● Complete process and analytical method development reports (including small-scale, non-GMP and cGMP campaign summary reports and associated raw data, and analytical qualification/validation reports)
● Reports that identify and outline any critical process parameters or controls
● Master Batch Records
A proven track record of success
We have a mature understanding and depth of knowledge that assist our clients through the development journey and into the market. We’ve established over ten manufacturing routes that have gone into the commercial setting, including the first in class polymers to IND.
We’ve a strong history of developing robust manufacturing strategies for highly complex small molecule APIs in the rare disease space. We also produce cGMP commercial pharmaceutical manufacturing ingredients such as Kifunensine and alpha Galactosyl ceramide, 2-fluorofucose and DHDT.
“I’ve had the great fortune to work with GlycoSyn for over 10 years now, on projects that span my time at Spinifex Pharmaceutical and Starpharma.
In all their work for me they have demonstrated a very high level of technical proficiency as they developed scalable synthetic routes to APIs and intermediates and executed cGMP campaigns. Their facility is first-class and is supported by an excellent analytical chemistry group and a robust quality assurance system.
What sets GlycoSyn apart is they do more than just ‘fee-for-service’ work; they commit to a project as if it were their own.”
Dr Tom McCarthy
CEO, Spinifex Pharmaceuticals
