ATMP manufacturing service
There are different stages of medicine development process and this includes, good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) requirements. We offer a range of advisory services and incentives for FDA and EMA requirements to support the development of CGT.
Regulatory strategy & valuation process
• Assessment and guidance on all aspects of the regulatory strategy for product development.
• Supporting manufacturers in the development of ATMP, biologicals, small molecules, devices, biosimilars and combination products including MD simulation for patient safety.
• Advice on ATMP, Fast Track, breakthrough therapy, accelerated approval, and ANDA submissions.
• Regulatory, quality assurance and compliance services for ATMP products and biologicals.
• Quality-based production and development of analysis methods.
• Formulation development.
• Assessment and assessment of stability data and requirements.
• Preparation and review of applications for admission.
• Risk-based strategies for product development.
• Supervision of contractual services.
• Design, implement and upgrade manufacturing systems for a range of ATMP products, including small molecules, biologicals and biosimilars.
Establishing a phase appropriate analytical development strategy that balances adequate product characterization with development speed and flexibility is a key challenge for Cell and Gene Therapy developers. Our team brings a wealth of experience across assay types, product platforms, and stages of development to address your analytical development challenges. Common offerings include:
Our scientists assist in identifying and selecting appropriate analytical methods for your product, and in developing and optimizing such methods to be fit-for-purpose.
Quality by Design of Bioassays:
We help you identify critical quality attributes (CQAs) of your products and to discern assays best used for release versus product characterization. We use statistical process analysis tools, combined with a wealth of experience regarding global regulatory expectations, to help you select appropriate specifications for your individual product and phase of development.
We ‘hand carry’ your analytical method to its new home to ensure success of your method transfer. We prepare your documentation, oversee planning and execution of the method transfer, and provide in-person oversight for the transfer at your CRO/CMO.
Qualification and validation:
We design protocols for performance verification of your analytical method, oversee method qualification/validation studies, and write or review technical reports summarizing study results.
We advise, assist or lead methods to remediate test method failures, whether in house or at your CRO/CMO.
We design a customized roadmap for establishing equivalence to ensure that manufacturing changes (be they in location or process or both) are satisfactorily comparable, streamlining your future regulatory needs. We have extensive experience in study execution, data analysis, report writing, and drafting and submitting regulatory filings; we are also available to represent you at regulatory meetings to discuss those filings.
EMA and FDA filings
• Compose, review and publish original requests, changes and additions for ATMP products.
• Create or support the refinement of the regulatory strategy.
• Non-clinical development.
• Support for non-clinical pharmacology and toxicology for ATMP products and biologicals.
• Support in early development planning.
• GLP advice, supervision and compliance.
• Non-clinical program review and strategic support for EMA and FDA filings.
• Safety assessments for ATMP products, biologicals, small molecules, devices, biosimilars and combination products.
• Review of study protocols and reports for scientific performance and compliance with legal regulations.
• Clinical regulatory expertise for products in all phases of clinical development.
• Preparation of clinical trial applications.
• Clinical gap analysis, product development plans and value assessment process assessments.
• Development of the clinical protocol of phase 1-4.
• Review of clinical data in EMA and FDA style.
• Support of clinical studies for ATMP and biologicals.
• Planning clinical trials and monitoring trials conducted by CROs or individual investigators, including CRO selection and contract negotiation, tasks and schedules for clinical operations, selection of investigators / locations, on-site training, preparation / review of study documents, medical surveillance and DSMB organization.
Transfer of ATMP products worldwide
• Transporting biological samples within 12 hours to all countries in the world.
• Providing solutions for the transportation under controlled conditions.
• GMP and GLP setup as well as GCP compliance.
• Gap assessments, PAI readiness.
• Audits program.
• Data checks (integrity and validation).
• Validation of computer systems (CSV) and compliance with part 11
In Vitro & Companion Diagnostics
• Competent technical instructions for in vitro diagnostic product development and regulation strategy, including accompanying diagnostics and personalized medical devices.
• Analytical and clinical study design and study management.
Building and managing od quality systems & training
• Support in the development of the documentation for the quality system, including expert technical reviews of the software development processes.
• Internal training on regulatory issues of the EMA and FDA and new policy developments.
Screening, developing and implementing the optimal cGMP manufacturing strategy to overcome the challenges in ATMP Manufacturing. Our experienced team assists you in all aspects of this journey, including:
We build highly flexible manufacturing plans based on cost models to help you identify whether in house or outsourced manufacturing best suits the needs of your development program, optimize capacity planning, and identity high priority opportunities for cost reduction. (See more details on the Quant Modeling page here.)
Using our proprietary, quantitative RFP process, and our deep knowledge of the cell and gene therapy CMO landscape, we author your RFP, solicit responses from qualified contract manufacturing organizations (CMOs), audit lead candidates, and evaluate responses to select the optimal partner for the specific needs of your process and organization.
We ‘hand carry’ your process to its new home to ensure success of your technology transfer, whether in-house or to a CMO. We prepare your technology transfer package, oversee planning and execution of the process transfer, and provide person-in-plant support for the transfer.
GMP facility design:
We assist you in designing a facility that is optimized for the needs of your specific process and organization. Our experienced scientists and engineers develop conceptual designs tailored to your process and workflow. Our architect translates those designs into comprehensive buildout plans. Our project management professionals solicit competitive quotes and oversee project timelines.
Failure Analysis and suggestion of corrective actions:
We use formal root cause analysis tools like Fishbone Diagrams, Failure Modes and Effect Analysis, and statistical analysis to identify root causes underpinning lot failures. Once root cause(s) are identified, we assist you in identifying, implementing, and documenting appropriate CAPAs to prevent them from re-occurring.
Marketing of ATMP products
• Worldwide marketing strategies in different languages.
• Representing your company in the international ATMP-events.