We support biotech/pharmaceutical companies in commercializing advanced-therapies - such as gene- or cell-therapy, tissue engineering and vaccines.
Gene- and cell therapeutics as well as tissue-engineered products offer fundamentally new treatment opportunities for unmet medical needs. In Europe, such approaches are referred to as Advanced Therapies and related products referred to as "Advanced-Therapy Medicinal Products" or Advanced Therapies, denoting them to be a third class of medicinal products in addition to drugs and medical devices. To market such products in the EU, a market of 500 million people, specific regulatory, quality and process parameters have to be observed.
Throughout the years we have served clients throughout the EU, Israel, USA, India and South Korea.
In addition, we offer to drive projects in regard to interims management, business development and investor relations.
In summary, we enable innovators to market their products earlier so that investors and patients can reap the benefits from efficacious, safe and novel therapies earlier.
Once evidence has been gathered supporting the drug candidate, a specific needs to be developed/agreed upon. Key features include product specifications, and critical quality attributes. Based on these, individual process steps may be designed for robustness, approvability, economy and scalability. Following risk assessments in-process-controls can be designed and implemented
We offer to
Based on the client’s process, we design manufacturing plants. Our specialty is in aseptic manufacturing such that products which may not be terminally sterilized can be manufactured with assured sterility.
For this, we design plant layouts supporting the desired processes in clean room cascades D-A acc. to EU GMP with appropriate pressure cascades, flow of people, goods, product and waste as well as suitable ingress/egress procedures, gowning for personnel as well as environmental monitoring as well as alarming mechanisms.
Execution occurs in collaboration with engineering firms.
Complying with EU-GMP and PIC/s guidelines we generate quality systems including
· Quality manuals
· Site master files
· Master batch records
· Work sheets and related
We believe that the art in generating quality systems, SOPs and such is in meeting GMP standards while being mindful of the physical realities of a particular plant and process. Our profound experience enables us to generate clear instructions which are practical to follow by operators, thus maximize compliance and minimize errors.
We advocate following the EU-GMP/PIC/S nomenclature so that individual documents can be easily identified as belonging to particular subsections of the quality system, e.g. to manufacturing.
Clean rooms and all other equipment used in GMP manufacture qualified prior to use.
Depending on the complexity of each piece of equipment, a subset of User Requirement Specifications (URSs), requirement traceability matrices (RTMs), Design-, Installation-, Operational- and Performance qualification as well as factory acceptance tests (FATs) and/or Site Acceptance Tests (SATs) and equipment specific risk assessments -Failure Mode analyses (FMEA) will be executed with appropriate Quality pre- and post-approval.
Previously also referred to as Media Fill, is perhaps the central tool in demonstrating the ability to carry out an aseptic process while maintaining aseptic conditions. It is not a 1:1 reflection of the process but mirrors subsets of the envisioned process in a fully controlled set-up using microbial growth media instead of actual process liquids. Any breach in aseptic technique can be detected by analyzing the resulting samples for microbial growth and, in its absence, proof can be provided for being able to carry out the required aseptic manipulations.
Once successful, process validation may ensue.
Once processes have been defined, qualified equipment is available and the process has been simulated successfully, process(es) will be validated, e.g. executed with a minimum of three repeats and results compared to pre-defined criteria*. If successful, validation reports will be generated documenting the successful process validation.
*Alternative approaches may be used.
Drug manufacturers are responsible for their product’s quality including the quality of their suppliers. Vendor qualification programs rely on vendor audits and we offer to perform these.
Clients also may choose to have themselves audited by an independent party and we provide this service.
We also provide audit services to clients which consider entering the EU market from abroad.
According to the tripartite ICH Q9 guideline drug manufacturers need to maintain quality risk management (QRM) systems so that risks may be addressed preventively rather than been dealt with retrospectively.
We offer to generate QRM systems at clients and to integrate these with the client’s quality system.
We further offer to conduct risk assessments and to generate the required documentation – QRM plans and reports so that client’s are compliant in regard to QRM.
Once a company or academic group plans to produce a drug intended for human use in the European Union, it needs a . This includes a full review of the processes, the manufacturing plant and quality system/documentation by the competent authorities; in Germany this might include district governments and the Paul Ehrlich Institute.
It further involves having a Qualified Person (QP) at one’s disposal which can competently release product.
We provide QP services.
For investigational medicinal product as well as for commercial products manufactured outside of the EU, an is required. This entails reviews by the authorities similar to that for a manufacturing license, Qualified Person (QP) release plus a legal representation within the EU.
We provide import and QP release services.
Manufacturers located outside of the EU are required to provide a legal representative within the EU so that authorities have appoint person at their immediate disposal.
We provide such legal representation.