SynCo’s multi-purpose GMP facilities offer manufacturing capabilities for microbial based biopharmaceuticals for worldwide supply according to the highest quality standards. As one of ten to fifteen biopharmaceutical CMOs in the world with both clinical and commercial manufacturing experience our clients benefit in having lower risk manufacturing and overall costs in moving their product from ‘bench to market’. Our clients also benefit from our ‘one stop shop’ service offering (for example, development, bulk drug substance and drug product production), providing program flexibility, reduction in time and an overall reduction of costs.

The GMP microbial facilities for the production of clinical phase and marketed products at SynCo include:

SynCo continuously expands its expertise and capabilities and adds novel production technologies to its manufacturing offering.

QC Testing 

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Quality Assurance

The Quality Assurance department at SynCo provides and maintains the GMP quality system within SynCo and supports all aspects of the GMP biopharmaceutical manufacture to ensure the products meet the highest quality standard and regulatory compliance.
At SynCo, we are committed to our clients’ success, so it is our mission to help your product reach its full potential with the highest possible quality. SynCo has a long and a very successful track record in inspections of its biopharmaceutical production facilities in Amsterdam, by its clients and many different regulatory authorities.
Operating as a CMO demands constant evaluation of our quality systems. To meet the high quality standards required SynCo’s Quality Assurance department works closely with SynCo’s internal organization and our clients to ensure that each project meets full regulatory compliance. SynCo is committed to continuous quality improvements and our goal is to provide biopharmaceutical products to our customers that meet the highest safety and quality standards.
“Trust us to make it right”

Stability Testing 

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Regulatory Affairs Support

SynCo has a strong track record in supporting clients through the manufacture of clinical trial material and licensed products. With this experience comes the expertise to be able to offer our clients support in their regulatory filings with respect to the CMC sections. SynCo’s full-time employed Qualified Persons (QP) and members of the Quality team work closely with our clients to ensure that potential issues are brought to light and addressed within the work program, as well as providing relevant and appropriate documentation and data in a timely manner. Over the years, SynCo has successfully supported its clients in a number of INDs, IMPDs, DMFs, MAAs and BLAs.
Regulatory compliance
SynCo’s facilities have been a licensed manufacturing site for drug substance and aseptically prepared small volume parenterals (drug product) since 1992 and SynCo’s GMP license covers both clinical and commercial supply of biopharmaceutical products.
In addition to regular inspections by the Dutch regulatory authorities in accordance with EMA regulations, SynCo’s facilities have been inspected by the major international regulatory authorities in view of the licensed products produced at SynCo.
Since 1992 SynCo’s facilities have been a licensed manufacturing site for drug substance and aseptically prepared small volume parenterals (drug product). SynCo’s GMP license covers both clinical and commercial supply of wide variety of biopharmaceutical products.

SynCo aims for a long term partnership and has brought several protein & vaccine projects over the past years, from early stage development through the clinical phases into commercial launch and production.

Regulatory Submissions 

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Quality Control

The Quality Control (QC) department of SynCo is responsible for sampling and testing a wide range of materials including raw materials, in-process samples, drug substance samples, drug product samples, stability samples and environmental monitoring samples. SynCo’s QC staff is trained in state-of-the-art analytical techniques. The instruments SynCo employs are validated according to current guidelines (including ICH) and the methods of analysis meet all international requirements and will be qualified / validated for the specific product development stage.
SynCo’s QC department consist of three groups, the Microbiology group, the Analytical (Bio)chemistry group and the Transfer and Validation group. Both the Microbiology group and the Analytical group are involved in raw material testing, in-process control testing, bulk drug substance testing, drug product testing and stability testing. The Transfer and Validation group is responsible for the transfer of analytical methods and set-up of new methods to support our client production processes.