Competencies & Services
Polpharma is recognized as one of the leading CDMO companies in Europe, specializing in the production of Active Pharmaceutical Ingredients (APIs). We partner with our clients throughout the entire product life cycle, from early-stage clinical candidates to commercial launches. Our cutting-edge facilities for R&D, pilot production, manufacturing, and quality control, combined with our extensive expertise in developing and manufacturing highly complex APIs, allow us to offer a diverse range of services across the value chain, ensuring tailored solutions for every project.
R&D Laboratories
Strong R&D team with a great experience in development of chemical processes and complex projects, provide a wide range of solutions to our customers. Our R&D facility is about 1 000 sqm and includes 10 laboratories, 30 fume hoods with state of the art instruments to support chemical and analytical development projects.We have extensive expertise in particle design, crystallization and bi-phosphonate compounds.
Heading 1
Heading 2
Heading 3
Heading 4
Heading 5
Heading 6
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.
Block quote
Ordered list
- Item 1
- Item 2
- Item 3
Unordered list
- Process chemistry, from full development, through transfer, to production
- Analytical methods transfer, development, validation
- Process development, process optimization
- Second-generation process for cost control
Bold text
Emphasis
Superscript
Subscript
%203.avif)
FDA-approved GMP facilities from pilot plant scale to multi-ton manufacturing scale.
Security of supply assured by network of well established partners or back integration of intermediates and starting materials.
State-of-the-art QC laboratories for product release.
Dedicated Project management to ensure the best possible customer experience.
Our R&D center is equipped with ~1 000 sqm facility counting
10 laboratories, 30 fume hoods with state-of-the-art instruments to support chemical and analytical development projects.
- New chemical routes full development
- Process optimization
- Technical transfer
- Analytical methods development, transfer, validation
- Troubleshooting
- Crystallization studies
- Particle size distribution control
Key technologies and expertise
- Amidation
- Acetylation
- Bromination
- Chlorination
- Chlorosulphonation
- Cyclization
- Coupling
- Carboxylation
- Dehydrogenation
- Lithiation (with BuLi)
- Chlorosulphonation
- Esterefication
- Friedl-Craft’s alcylation
- Grignard’s reaction
- Hydrogenation
- Methylation
- Metho-/Ethoxylation
- Oxidation/Reduction
- Phosegenation (with triphosgene)
- Saponification
- Strong base reaction
Pilot Plant
Our Pilot Plant is an independent, small scale FDA approved production facility counting more than 25 reactors and vessels from 50 to 650 L for a total of 6 m3 capacity.
3 different and fully segregated clean zones for final APIs processing enable 3 parallel projects to run independently. Pilot Plant operations are designed and maintained an exactly the same standard as the production environment at the target commercial scale, which ensures a smooth process transfer at a larger scale (same quality, EHS standards, format for Batch records and SOP’s are applied as for production areas).
This facility runs 24h/day and 7 days/week and giving its capacity and flexibility is used for both scale-up studies to prove process robustness and also routine manufacturing of relatively small volume commercial API.
.webp)
.webp)
.webp)
.webp)
.webp)
.webp)
.webp)
.webp)
Security of supply
Polpharma's efforts in cost-efficiency and innovation ensure the continued growth and sustainability of the API market, providing access to effective and affordable medications.
- Well-established and controlled suppliers qualification process:
- Paper Audit
- Personal on-site Audit (For Intermediates and selected Regulatory Starting Materials)
- Risk-based approach
- Managed by a separate QA Team dedicated to Suppliers Qualifications.
- Own a Team of well-trained auditors. Auditors employed by Polpharma have a seat in Asia.
- Periodic requalification (Every 3 years)
- A broad network of reliable European suppliers qualified for solvents and basic chemicals that are in common use in API production.
- Wide group of high-quality, GMP-compliant suppliers for Intermediates and Starting Materials qualified by Polpharma ready to produce custom intermediates on an exclusive basis.
- Multipurpose lines give flexibility in planning and enable to implement your process in different lines as a contingency plan.
Quality
Facilities for the production of APIs undergo rigorous inspections from the U.S. Food and Drug Administration (FDA). Our multipurpose plant passed FDA inspections in 2004, 2009, 2012, 2015, and, most recently, May 2018. This is something we are proud of and that confirms the highest quality standards of Polpharma.
Inspections & Audits
We have EU GMP certificates for all production departments and all
products.
.webp)
US FDA
Polish MPI
Polish MPI
Polish MPI
ANVISA Inspection
Polish MPI
Quality & compliance
- Documentation in an eCTD format and CEP certificates
- Specifications for every stage of production
- Qualification and audits of suppliers
- Quick response to complaints
- System procedures
- Compliance with cGMP
- On-the-job GMP training
- Validation and qualifications of equipment and production processes
Customer Experience
Our team of highly qualified, skilled, and passionate experts, coupled with cutting-edge equipment and facilities, ensures that our business partners receive an exceptional customer experience. Discover how our partners rate us and read their testimonials here.
Deep knowledge and technical support provided by Regulatory, analytical and chemistry in determining a strategy for potential genotoxic and elemental impurities as well as the experimental data needed to back it up. Finally, I have found Polpharma’s quality systems and people to be among the best that I have experienced.
The relationship we have with Polpharma represents a true partnership, Polpharma recognise that they are part of our Supply Chain and that they play a key role in ensuring that our patients are never without their product. This is demonstrated by Polpharma’s collaborative approach, their flexibility, their proactiveness in identifying opportunities, and their technical competence. The partnership that we have with Polpharma is a model that we aspire to developing with all our suppliers.
One of the most important benefits I see in working with Polpharma is the relationship of teamwork and transparency. It is remarkable that after almost 5 years on this project, the key team members including project leader, analytical chemistry, process chemistry, Regulatory and Quality, have remained essentially the same. I have never seen this with another CMO and the continuity that it provides has been invaluable.
Our CDMO Team
Partner with our enthusiastic and dedicated team on your upcoming project! We are eager to collaborate and deliver outstanding results together. Let's make your vision a reality!
“The objective of a CDMO is to provide a service in all stages of development that allows its customers to be fast to market. This is our commitment. We also assume the commitment to provide solutions from a supply chain perspective that would allow our customers to have a sustainable solution for the long term.”
“After 15 years at Polpharma every day reasures me that the greatest assets we have are our committed, skilled scientists and the strong relationships we have built over the years with our Customers and Business Partners. The trust we have been granted and our customers’ satisfaction is the engine that always empowers us to strive for better service.”
“Collaboration and communication between R&D, production and the customers involve a wide range of interdisciplinary skills that are offered to the customers and are critical to the successful development of drug substance and drug product.”
