Stolley Engineering is your technology partner for GMP Engineering Services for Biopharmaceuticals and Immunotherapies.
Welcome to Stolley Engineering
Stolley Engineering is a bioengineering company with expertise in GMP engineering for the biopharmaceutical industry and treatment centers for gene and cell therapy.
Our company specializes in validation and qualification for sterile manufactured biopharmaceuticals and ATMPs (immunotherapies). Validation and qualification are central elements of GMP requirements and mandatory to receive manufacturing authorization 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 authorization is a compulsory GMP requirement.
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.
With more than 20 years of hands-on experience in bioprocessing, biomedical research, and manufacturing of biological products, 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 biopharmaceuticals and gene therapies (ATMPs).
“We believe that the innovation behind each new drug development starts with good manufacturing practices (GMP).”
Our GMP Services
GMP Services
- Validation Services
- Commissioning & Qualification
- CSV & Data Integrity
- Quality Control Testing
- In-process Testing
- Scientific and Laboratory Assistance
- Upstream & Downstream Operations
- Technical Transfer
- Risk Management
- Statistical Analysis
Validation Services
- Analytical Method Validation
- Bioassays
- Process Validation
- Computerized System Validation (CSV)
- Cleanroom Validation (Annex 1)
- Statistical Analysis
Qualification Services
- Analytical Instrument Qualification
- Process Equipment Qualifications
- Commissioning & Qualification
Providing GMP Expertise
- Manufacturing of biotechnological products and immunotherapeutics (ATMPs)
- Cell and Molecular Biology
- Gene Technology
- Quality of Biotechnological Products
- Specification of Biotechnological Product
- Analytical Procedure Development
- Preclinical Development
- Pharmaceutical Quality System
- Quality Risk Management
- Data Integrity and computerized Systems (CS)
- European Commission’s Guide to GMP
- ICH Quality Guidelines
Your GMP Benefits
- GMP compliant manufacturing of Biopharmaceuticals and ATMPs
- Manufacturing authorization
- Clinical trial and marketing authorization
We are contributing to regulatory requirements for GMP release of samples according to customer’s needs and exigencies.