GMP Engineering for the Biopharmaceutical Industry
Welcome to Stolley Engineering
GMP Services tailored for Biopharmaceuticals and Gene Therapies
Stolley Engineering is a bioengineering company with expertise in GMP engineering services for the biopharmaceutical industries and treatment centers for gene therapies.
Our company specializes in validation and qualification for sterile manufactured biopharmaceuticals and gene therapies.
Validation and qualification are central elements of GMP and mandatory to receive manufacturing license and to support marketing and clinical study authorization by regulatory authorities.
Pharmaceutical products are subject to high quality standards as part of submission for regulatory approval. Among these are: reporting adverse drug reactions; monitoring clinical trials and conducting inspections of manufacturers; compliance with good clinical practice (GCP); good manufacturing practice (GMP); good distribution practice (GDP), and good pharmacovigilance practice (GVP).
Manufacturers of pharmaceutical products are legally obliged to comply with good manufacturing practice (GMP). For their manufacture, distribution and marketing authorization, a manufacturing license is required. Therefore, for a drug manufacturer, the manufacturing license is a basic GMP requirement.
With more than 20 years of hands-on experience with GMP engineering, bioprocessing and biomedical research, we contribute expertise in analytical instrument and process equipment qualification, cell-based bioassay procedures, bioanalytical method validation, and quality control operations. We guide you through your cGMP compliant manufacturing processes of immunotherapeutics and gene therapies.
Our GMP Services for the Biopharmaceutical Industry
“We believe that the innovation behind each new drug development starts with Good Manufacturing Practices” (GMP).
The refinement and optimization of implementing GMP quality standards requires daily teamwork in different operation units and disciplines. Designing validation and qualification concepts, quality control, quality assurance, manufacturing and IT works at its best closely together in qualification or validation teams.
When we develop those validation and qualification strategies, we apply the “Lean GMP Validation Concept”. This helps us to follow refinement and reduction but keep to the regulatory expectations. For our clients, it saves time and money by avoiding unnecessary, time- consuming, and costly validation and qualification activities.
In regular project meetings, we develop and optimize the approach on implementation of qualification and validation concepts. Our validation engineers employ mind and reason to establish the objectives of your validation and qualification strategy.
YOUR BENEFITS
Supporting regulatory requirements for GMP release
- Contributing to cGMP compliant processes
- Supporting license registration
- Supporting manufacturing authorization
- Supporting clinical trial and marketing authorization
Providing Expertise
- Hands-on experience with process validation, method validation, bioassays and computerized system validation
- Hands-on experience with analytical instrument and process equipment qualification
- Expertise in aseptic processing (Annex 1) and bioprocessing of recombinant proteins
- Proficiency with GMP requirements and regulations (FDA, EMA, PEI, BfArM, ZLG)
- Expertise in biomedical research and bioengineering
- Proficiency in laboratory technologies
VALUED-ADDED SERVICES
Cost-saving and time-effective
Through our focus on GMP compliant necessities and effectivity in applying the Lean GMP Validation Concept, client’s time and costs can be saved.
Customized solutions
Tailored GMP Services with emphasis on biopharmaceuticals, biosimilars and gene therapies will be offered product specifically and in reference to customer’s needs.
GMP class
After the implementation of GMP quality standards, it is vital to maintain the acquired status. QS is responsible to oversee those subsequent activities. Yet, another essential part is the staff qualification in terms of GMP necessities, their requirements and regulations.
We give on-site training on specific topics, tailor-made to the company’s desire, products and processes.