Docstoc

Aseptic Filling and Lyophilization Services

Document Sample
Aseptic Filling and Lyophilization Services Powered By Docstoc
					                                                                               SynCo Bio Partners B.V.    Phone +31 (0)20 750 36 06




                                                                                                                                               FILLING & LyOPHILIzATION
                                                                               Paasheuvelweg 30           Email contact@syncobiopartners.com
                                                                               1105 BJ Amsterdam          Website www.syncobiopartners.com
                                                                               The Netherlands




Aseptic Filling and
Lyophilization Services
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

       Pr
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
                                                                                              Further Information
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
                                                                                              contact@syncobiopartners.com or
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
                                                                                              more details.
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.