Whether it is a greenfield project or a modification to an existing facility, Adryan Consultants has the engineering experience in various processes in the (Bio-) Pharmaceutical and High-End Food industry. We can deliver highly skilled professionals and/or a dedicated group of engineers who can provide engineering-related services such as design, supervision, execution, creation of drawings and specifications, process automation (from URS, FDS, SDS to implementation and qualification) and make recommendations to the client.
This includes clean rooms and air treatment (HVAC), fermentation processes, downstream processes, aseptic filling processes, CIP, SIP, freeze-drying, sterilization, water and steam treatment (WFI, purified water, clean steam), etc.
The projects in the Oil, Gas & Chemicals industries are maintained according to more demanding standards for safety, quality, health and environment. In this sector Adryan Consultants has experience with the design, construction and commissioning of typical equipment, such as dryers, evaporators, extruders, cyclones, filters, reactors and tanks.
All the projects we undertake are engineered and carried out in close cooperation with the customer and any third party suppliers. We start by evaluating the feasibility of a project, followed by design and construction of customized equipment. We ensure successful execution of the project or replacement and subsequent follow-up.
In a nutshell: We take on, organize and execute the entire job, start to finish, relieving the customer of all the issues of coordination, planning, supervision and hand-over.
Adryan Consultants has a highly skilled and experienced group of senior consultants who help our customers in various ways, for example:
- facilitating a high-level preliminary meeting for project start-ups
- performing gap analyses in order to qualify systems and asset management
- execution of pre-audits to get a facility IGZ, EMA and FDA ready, mainly focussing on quality systems, production, maintenance, packaging and logistics.
“The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement” (source: ICH Q10 (Pharmaceutical Quality System).
Adryan Consultants has successfully executed several Tech transfer projects. Typically we are hired to manage the overall project, including process transfer and manufacturing process scale-up.
In those cases we established a dedicated Process Team of bioprocess engineers who are responsible for the implementation process steps and for the execution of the pre-GMP and first GMP runs, with the support of QA, QC, Bioprocess Support and other departments related to production.
Technology Transfers occur between two parties (a Sending Site and a Receiving Site), within any transfer of the product life cycle, e.g.:
- laboratory to laboratory scale
- laboratory to development/pilot scale
- development to clinical manufacturing
- development to launch/commercial manufacturing
- drug substance to secondary manufacture
- lead manufacturer to third party manufacturer.
Our standard approach to Process Validation consists of the following stages:
- Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities, according to the ICH Q8 (R2) Pharmaceutical Development.
- Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
- Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
Adryan Consultants can be your partner in achieving a successful technology transfer.