SynCo Bio Partners B.V. Phone +31 (0)20 750 36 06
FILLING & LyOPHILIzATION
Paasheuvelweg 30 Email email@example.com
1105 BJ Amsterdam Website www.syncobiopartners.com
Aseptic Filling and
SynCo Bio Partners B.V. is a GMP contract
manufacturing organization offering a fully
integrated range of services in biopharmaceutical
manufacturing and supports companies from the
earliest stage in process development, through
clinical trials to market supply.
SynCo Bio Partners, specializes in the aseptic
filling and lyophilization of biopharmaceuticals.
Consistent with our aim to apply new technologies
into commercial operations SynCo have also been
breaking new ground in the bulk freeze drying of
products in Lyoguard® trays.
SynCo offers clinical and licensed Following the completion of the FDA and Health Canada) in view of the
product aseptic filling services for filling operations, SynCo also has licensed products produced at SynCo
biopharmaceuticals, with experience a well established QC team with that are registered in many countries
in the supply of Drug Products for use experience in the release testing of outside Europe.
across the world. This experience biopharmaceuticals for clinical trials and
includes the production of the following for licensed products, including sterility
product types: testing, endotoxin, pH, uniformity of Frequently Asked Questions
• Aseptic liquid filling or lyophilization dosage units and residual moisture, What filling and inspection
(Lyoguard™ trays or vials): appearance and a wide range of product equipment does SynCo utilize?
specific assays. SynCo has a Flexicon Monoblock
o Monoclonal antibodies
(FMB210L) semi-automated filling
o Recombinant proteins
GMP Licensed machine for DIN vials in the 2R to 20R
o Aluminium-containing vaccines size range. 100% visual inspection is
SynCo Bio Partners B.V. is licensed
o RNA/DNA by the EMEA for the GMP production performed manually. All product contacting
o Allergy vaccines of clinical and market supply of components, i.e. filling needle and tubing,
biopharmaceuticals under license are disposable, whilst filling bottles are
Our filling operations include a formulation number: 108716F. The manufacturing product dedicated, allowing SynCo to fill a
and preparation area, with an aseptic filling site has been licensed for the production wide range of biopharmaceuticals.
suite which contains a semi-automated of bulk drug substances and aseptic
filling machine (filling, stoppering and Under what conditions are filling and
filled dosage forms since 1992. SynCo is
capping in 1) and freeze drier (6m2). capping operations completed?
regularly inspected by the Dutch regulatory
Capping of vials is carried out using the
SynCo’s filling process is fully validated. authorities, on behalf of the EMEA.
Flexicon Monoblock system which is
Depending on vial size (DIN 2R to 20R), In addition to EMEA compliance, SynCo’s under a ISO 5/EU Class A laminar airflow
fill sizes can range from 1,000-17,000 facilities have been inspected by foreign regime. The filling machine is located in a
units per batch. regulatory authorities (ANVISA, Korean ISO 6/EU Class B background.
SynCo GMP Manufacturing Experience
Preclinical Phase I Phase II Phase III Marketed product
SynCo’s GMP manufacturing experience spans all clinical phases and post market launch. Every year, multiple marketed products
are produced at SynCo’s Amsterdam facility.
What size is SynCo’s lyophilizer? Is SynCo able to provide ICH These extra checks help to ensure your’s
FILLING & LyOPHILIzATION
SynCo has an Edwards Freeze drier of stability testing? and SynCo’s success and to keep batch
6m2 (64.5 Sq feet) which is used for both SynCo is capable of providing its failures exceptionally low.
clinical and commercial applications. The customers with GMP stability studies
SynCo’s sensible risk-based approach
shelf sizes are approximately 610mm x to support their drug development
helps to ensure that projects are run
1219mm (24 x 48 inches). programs, offering a considerable saving
on time and on budget. In addition,
in sub-contractor project management.
What types of process equipment SynCo’s flexible and state-of-the-art
The stability studies can be provided
does SynCo use? semi-automated filling line means that a
for a range of different product stages,
For product contact applications, SynCo huge range of biopharmaceutical products
including pre-clinical, Drug Substance
works exclusively with disposable or can be filled or lyophilized. Together with
and Drug Product.
dedicated processing containers for filling its excellence in GMP quality standards
and finishing activities which are usually since its inception, in short, you can trust
Schott Glass, or plastic bioprocess Filling your Biopharmaceutical us to make it right!
containers/bags. SynCo also has the at SynCo
For the majority of biopharmaceutical
capability to mix in sterile bioprocess
products, project commencement is
containers using the LevTech Mixer For further information about any
system (up to a current scale of 100L). quick and simple because SynCo’s
aspect of SynCo’s GMP manufacturing
procedures and capabilities are well
services, please contact SynCo’s
What are SynCo’s pre (raw material) established. SynCo’s experience in
business development team at
and post (Drug Product) manufacturing biopharmaceuticals is one of the widest
inspection capabilities? in the industry. With this range of
see www.syncobiopartners.com for
Raw materials can be tested in house experience, you can trust us to
for the most common tests, but we also make it right.
use approved sub-contractors to execute
additional testing as required (based As with any biopharmaceutical product,
for example on full monograph testing). SynCo is well aware that Bulk Drug
SynCo typically manages this whole Substance material is extremely valuable.
process for all of its customers. If a new product-type is to enter its filling
facilities, SynCo takes a risk-based
Drug Product vials are subjected to approach and recommends the best
a 100% manual visual inspection as course of action to its clients to minimize
standard. This inspection addresses expensive losses during GMP filling.
aspects such as product appearance, This approach is led by one of SynCo’s
absence of visible particles, damage to experienced project managers, who will
vial, cap and or label. be assigned prior to the commencement
What are SynCo’s component of your project.
preparation capabilities? For the introduction of a new product
All process related cleaning and into SynCo’s facility, the following risk-
sterilization activities are performed in reduction steps may be completed prior
house with the exception of support to your fill:
materials which are purchased as “sterile”
for example gamma irradiated bioprocess • Dry run to check BPRs, and
containers. SynCo also has a separate equipment settings
media and buffer preparation area to • Wet feasibility run with formulation
support manufacturing operations in the buffer only. This enables testing of the
supply of filtered sterilized processing fill line and needles with the aim of
solutions prepared with either WFI. minimizing future product losses.