Solida - Think outside the reactor
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Transcript of Solida - Think outside the reactor
www.solidapm.com
1
THINK OUTSIDE THE REACTOR
www.solidapm.com
2WHO WE ARE
Solida is a Contract Manufacturing partner specialised in development and
manufacturing of API for pharmaceutical companies.
We are born from the evolution of PolyCrystalLine,
which after 10 years of experience in the development
and optimization of APIs crystallization decided to
combine its know-how in solid-state chemistry with
process development and optimization, up to
kilograms supply of API.
Solida now offers a comprehensive portfolio of solutions to fully control and
understand your crystallization process, thus enabling consistent, robust
production of quality products.
www.solidapm.com
3
WE CARE ABOUT RESULTS AND
INNOVATION BASED ON THE USE OF
MODERN TECHNOLOGIES.
EVOLVING THROUGH RESEARCH
www.solidapm.com
4THINK OUTSIDE THE REACTOR
For all substances, even if already marketed,
there is still a need for development of:
• More covenient processes
• Improve knowledge about the process
• Decrease pollution
• Purer final products
Hundreds of ideas can be generated, only a few can be tried in the laboratory.
That’s why it’s crucial to NOT be inhibited by what has been carried out previously.
It must be noted that yield and total number of steps are only two among
many parameters that we need to consider.
Quality
Safety
Pollution Cost
Durability
www.solidapm.com
5
PROCESS OPTIMISATION
SYNTHETIC ROUTE SCOUTING
PROCESS VALIDATION
PROCESS DEVELOPMENT
& SCALE-UP
SYNTHESIS OF REFERENCE
COMPOUNDS
Reproduce and scale-up
the selected procedure to
obtain the desired form.
Investigation of the effect of
crystallisation parameters
and seeding on final PSD
and morphology.
Resolving synthesis issues,
determine best synthesis conditions
and identification of the best
synthetic route for development.
Ensure that your process is
properly designed executing
DoE studies and statistical
assessment utilising QbD.
OUR SERVICES
www.solidapm.com
6
SYNTHETIC ROUTE
SCOUTING
OUR SERVICES
Our highly experienced scientific team has a proven
history of achievement with complex chemistry
challenges and can support you to synthesize any
challenging molecules, from grams to kilograms by
designing new synthetic route and for highly quality.
How can we help you?
• Optimise and re-design your synthesis route with
respect to synthesis time, the environmental
impact, yield and purification
• Increase the efficiency of your processes
• Control and synthesis of impurities
www.solidapm.com
7
PROCESS
DEVELOPMENT &
SCALE-UP
OUR SERVICES
We offer efficient process development and rapid
scale up of multi-step procedures up to kg-quantities
of target material. We fully support our clients
during the technology transfer, in order to satisfy
every requirement by working closely with them
thus optimizing time and related costs.
How can we help you?
• We are able to manufacture from gram to
kilogram quantities of API
• High potency handling
• Rapid scale-up
• Real-time crystallisation monitoring to generate
detailed profiles
www.solidapm.com
8
PROCESS
VALIDATION
OUR SERVICES
We can develop the strategy to complete process
validation of new and equivalent processes, process
improvements and changes using a scale that ranges
from 1:500 to 1:1,000 of your manufacturing area.
How can we help you?
• Ensure that your process is properly designed
executing DOE studies and statistical assessment
utilising Quality by Design approach
• Qualify your process by verifying that appropriate
risk assessments and qualifications are in place
for your production facility
• Validation and qualification of all analytical
methods associated to your process
www.solidapm.com
9
SYNTHESIS OF
REFERENCE
COMPOUNDS
OUR SERVICES
Supported by the experience of Polycrystalline we
offer standard reference of crystalline forms for
R&D use and preclinical studies.
How can we help you?
• Scout the best API supplier on the market
• Perform a patent and literature search for
identifying the best crystallization procedure
• Reproduce and scale-up the selected procedure
to obtain the desired crystalline form
• Full characterization of the crystalline form with:
XRD, TGA, DSC, FT-IR, FT-Raman, PSD, U(H)PLC,
EGA and KF
• Deliver the crystalline form with high purity
profile and CoA
Solida Pharmaceutical Manufacturing
Via F. S. Fabri, 127/2 - 40059 - Medicina (Bologna) - ITALY
Office: +39 051 6970791 Fax: +39 051 851847
E-mail: [email protected]
www.solidapm.com
