In protecting the intellectual property and customer’s confidentiality information: Synco got the customers’ approval as efforts and experiences in ability of the field, these affirmations gives customers trust in Synco, and pushes Synco forward to make progress on a confidential system and precautions measurement, preventing the leaking of customers’ information and any other accidental leakage.
Synco is a High Innovative Fine Chemical Company incorporated in 2007 focused on the researching and development of innovative Speciality Chemicals, Agrochemical Intermediates, Pharmaceutical Intermediates, Nutraceuticals, Polymer and Catalysts Technology. We work closely with our customers - who are typically Agrochemical or pharmaceutical companies - helping them achieve fast progress into, and through, the field test and clinical development program.
Our track record of meeting customer expectations is founded upon:
· technical and functional excellence
· dedicated project team focus
· a commitment to quality and regulatory compliance
Every customer programme is unique, each is:
· managed in a structured and flexible way
· led by a nominated project manager / leader
· supported by a multi-functional team
? Project and work plan definition Implementation support
? Coordinate both technical and commercial aspects with the customer and
? Milestone and report progress of projects
? Conflict resolution
? Staff with BS, MS, and Ph.D. Chemists
? Knowledge of current regulations
? Resources of outside professionals
Create a collaborative working environment ahead of the commencement and throughout the project.
The project team stays in close contact with the customer, openly exchanging information throughout the project via a series of teleconferences and frequent face-to-face meetings. The project itself is clearly structured with agreed, defined and realistic milestones.
Find out what it’s like to work with Synco on a typical type of project by clicking on the links below:
· Early phase pharmaceutical project
· Late phase pharmaceutical project
· Agrichemicals or/and its intermediates
· Specialty chemicals
Each customer programme has a multi-functional team dedicated to it. This creates a strong, shared ownership of the project and fosters cross-team innovative think.
Early Phase Pharmaceutical Project
The programmes are designed with the customer to support Phase I and II trials. They typically consist of the following stages:
· technology transfer
· process creation (if expression system development is required)
· process & assay development and/or establishment
· process demonstration
· cGMP Manufacture in pilot plant (including preparation and batch review)
A typical programme takes approximately 3-6 months until completion and would deliver:
· cGMP material suitable for use in clinical trial
· material that could be used in preclinical studies
· commercial manufacturing process
· reports detailing development work and manufactures undertaken
Synco’s process development experience ensures that speed to clinic is maintained without compromising process robustness or product quality.
Late Phase Pharmaceutical Project
A late phase programme would typically be performed in pilot plant. The scope and timeframe of these programmes is much more variable and is largely dependent on the commercialisation strategy for the product.
The programme would typically consist of:
· laboratory process characterisation studies
· transfer to pilot production
· cGMP manufacture pilot plant (to support ongoing late-phase trial, multiple batch validation campaign or market supply)
· regulatory submission support
Synco works closely with customers to ensure an appropriate process validation strategy is employed. Balancing the need to demonstrate process robustness with the desire to control costs and minimize time to market.
Agrichemicals or/and its intermediates
An Agrichemical or/and its intermediates would consist of the following stages:
· technology transfer
· process creation and validation
· process and assay development
· process demonstration
· technology transfer to pilot production
Customers are not locked into a proprietary vector system at Synco: we can undertake development work to reduce royalties payable to third parties.
Process creation establishes a basic lab-scale process for the manufacture of preclinical and early clinical material.
The starting point may:
· build upon early work clients have undertaken themselves
· commence with just a gene sequence and require application of our extensive molecular biology capability
Synco is famous company in the development of processes for the manufacture of specialty chemicals, with particular expertise in:
· Process creation
· Process development, scale-up and optimization
· Process validation
Our experience enables us to understand the different development needs of products and clients at different field test stages
We ensure that development is applied appropriately, from fast-track process creation focusing on speed to the field test through to launch, fully validated processes underpinning successful and reliable long-term commercial manufacture.
Process Development, Scale-up & Optimization
Process development is a multi-functional competence requiring complete and effective integration of:
· upstream process
· downstream process
· analytical science
· process technologies
Synco works closely with its customers to take a holistic approach to ensure that all parts of the process are properly matched to achieve overall process performance.
The essential metrics of process yield, product quality and cost of goods are addressed through the use of statistical experimental design and artificial intelligence systems to identify the key parameters and their influence on the process.
Process validation is a manufacturing-based activity to demonstrate a controlled and reproducible process to meet the required material specification. It is supported by laboratory experimentation which includes:
· determination of critical control parameters and their operating ranges appropriate for the facilities on which the process will be run
· scale-down modelling of limits of re-use (for example, columns) and other formal frameworks to assess risk and aid good scientific judgement
· extractables studies
· good documentation to trace back and support developed rationales
These studies support the final process definition on the plant and dramatically reduce the likelihood of failure of validation batches.
Law and Regulatory Compliance
? Quality Agreement
? Quality Compliance
? DMF Preparation
? Assistance in FDA, EPA Preparation
? Specification Review
? Accountability Analysis
? Financial Arrangements