CDMO
We are a contract development & manufacturing organisation (CDMO) for customers who want to validate their own technology in production conditions, optimize it or produce medicinal products in the GMP standard on a small scale. We develop, manufacture and implement advanced therapy medicinal products (ATMP) in clinics. We offer cell isolation from various tissues and the production of products of various types of cells - stem and differentiated.
We have a GMP certificate, and currently we have the following permits necessary for the production of medicinal products:
- consent to manufacture advanced therapy medicinal products - hospital exceptions (ATMP-HE) - Decision of the Main Pharmaceutical Inspector;
- manufacturing authorization for the investigational medicinal product (ATIMP) - Decision of the Main Pharmaceutical Inspector;
- permission to collect and process human adipose tissue as well as processing, storage and distribution of human cells isolated from adipose tissue - Decision of the Minister of Health.
At our Pharmaceutical Manufacturing Facility, there are production rooms of cleanliness class B with laminar chambers of cleanliness class A, as well as locks of cleanliness class B / C / D and additional rooms of cleanliness class D, where activities related to production are carried out. The production rooms include 3 boxes, equipped with laminar chambers enabling the preparation of biological material and the production of products under aseptic conditions (A-class cleanliness), as well as a set of incubators for breeding. The rest of the equipment necessary for the process (centrifuge, microscope, cell counter, etc.) is located in the common area. Another 3 locks with cleanliness class D, C / D and B / C lead to the production part. There are also rooms for the qualification of biological material, as well as for issuing and reading microbiological samples. We also have our own Quality Control Department and a Cell Bank, necessary for the production of medicinal products. The total area of the production facility is approx. 100 m2. We have a fully automated system for controlling room parameters and apparatus - RMS / BMS system.
Undoubtedly, a great advantage for our clients is the combination of a GMP-standard manufacturing laboratory with the powerful research, development and clinical facilities of the Medical University of Warsaw. Taking advantage of our affiliation to one of the largest medical universities in Poland and the extensive practical experience of our experts, at LBBK we have created an R&D Laboratory specializing in the development of new cell therapeutics for clinical applications in the in vitro cell culture conditions. The laboratory is sufficiently equipped to conduct research and development of new methods of biological material preparation and to improve the methods of obtaining advanced therapy medicinal preparations. Find out more about research options and technical facilities here.
We offer our services in the field of the production of medicinal products in the hospital exception mode, for conducted medical experiments.
If you are a physician or a head of a clinic and you have a patient(s) who qualify for administration of a cellular therapeutic as part of a medical treatment experiment - contact us! As part of the cooperation, we also provide knowledge and experience in the field of obtaining the consent of the Poltransplant Body to collect tissue from the patient for the production of a medicinal product and the consent of the Bioethics Committee to conduct a medical experiment.
We are a laboratory that meets the requirements of Good Manufacturing Practice, confirmed by a GMP certificate issued by the Main Pharmaceutical Inspector. We have modern infrastructure, a competent team and experience in the production of medicinal products containing human cells.
We currently have the following authorizations necessary to manufacture medicinal products on a physician's individual request:
- consent to manufacture advanced therapy medicinal products - hospital exceptions (ATMP-HE) - Decision of the Main Pharmaceutical Inspector;
- permission to collect and process human adipose tissue as well as processing, storage and distribution of human cells isolated from adipose tissue - Decision of the Minister of Health.
Laboratory for Cell Research and Application is an excellent partner for individuals (companies and universities) interested in cooperation in the field of conducting and developing cell and tissue-based therapies.
We have experience in designing and conducting / implementing clinical trials, creating documentation and cooperating with offices, i.e. the European Medicines Agency (EMA), the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or the Main Pharmaceutical Inspectorate. We also have experience in manufacturing Advanced Therapy Investigational Medicinal Products (ATIMPs) for use in clinical trials.
The technical potential and the certificates, which are unique on a Polish scale, allow LBBK to legally manufacture medicinal products for clinical trials. We have the necessary qualifications.
- manufacturing authorization for the investigational medicinal product (ATIMP) - Decision of the Main Pharmaceutical Inspector;
- permission to collect and process human adipose tissue as well as processing, storage and distribution of human cells isolated from adipose tissue - Decision of the Minister of Health.
QC of pharmaceutical products
Service in preparation
Environmental hygiene monitoring services
We test the parameters of the manufacturing environment and eauipment in accordance with the requirements of the Regulation of the Minister of Health on the requirements of Good Manufacturing Practice (GMP) of March 18, 2019 and the requirements of the PN-EN ISO 14644 standard. The service is offered in the following scope:
I. Measurement of air quality in clean rooms (particle number).
We carry out measurements of the number of particles in the air of clean rooms and areas. The service is dedicated to rooms with A, B C or D cleanliness class in accordance with GMP guidelines (i.e. cleanliness classes 4 - 8 according to ISO 14644). Measurement of the number of particles in the air is performed using the passive air sampling method with the HandiLaz Mini particle counter. The air quality test will be documented with a protocol and report compliant with the GDocP rules.
The measurement can be performed based on the sampling points indicated by the customer or on the basis of points and a plan created by our team, specific to the customer's premises and needs (additionally payable service).
II. Assessment of microbiological purity of air and surfaces in clean rooms.
The offered microbiological purity tests can be performed in order to:
- clean room qualifications,
- routine cleanroom control of clean rooms,
- diagnostics of problems with microbiological cleanliness in clean rooms.
During the study, the following may be assessed:
- indoor air,
- room area (walls, floors),
- the surface of worktops or devices located in clean rooms.
- LBBK offers a microbiological purity monitoring service using the following methods: sedimentation, volumetric air sampling and contact sampling. The assessment of microbiological purity will be documented with a protocol and report compliant with the GDocP rules.
The test can be performed on the basis of the microbiological assessment points and the customer's test plan or on the basis of the points and plan created by our team, specific to the customer's premises and needs (additionally payable service).
Courses and trainings
We invite you to a "guided tour" of our Pharmaceutical Works. During the presentation, participants will have the opportunity to enter the clean zones of a GMP-compliant laboratory where advanced therapy medicinal products are made. During the training, the following will be discussed:
- ways of changing into sterile protective clothing,
- way of moving around in rooms with different cleanliness classes,
- practical aspects of work as well as technical requirements for clean rooms.
Presentation time: 1-1.5h
Maximum number of participants: 4
We invite you to a "guided tour" of our Pharmaceutical Works. During the presentation, participants will have the opportunity to enter the clean zones of a GMP-compliant laboratory where advanced therapy medicinal products are made. During the training, the following will be discussed:
- ways of changing into sterile protective clothing,
- way of moving around in rooms with different cleanliness classes,
- practical aspects of work as well as technical requirements for clean rooms.
The presentation will be supplemented with an introductory training consisting of lectures, during which the following will be discussed:
- Guidelines for working in clean rooms,
- Technical requirements for clean rooms in accordance with the Regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice, as amended,
- The most important legal acts regarding work in production rooms,
- Optional: rules for the production of Advanced Therapy Medicinal Products.
Training presentation time: 1-1.5h presentation + 2h lectures = 3-3.5h
Maximum number of participants: 3 *
