Warning Letter and 483 Response Support
Our team understands the regulatory and compliance complexity that comes with operating a facility that is regulated in multiple markets. In our experience there are times when there are regulatory challenges that are highlighted by clients or global regulators. The management and response to these observations are crucial and require a level of independence and systematic process. Our rapid assessment program and quality improvement plans can lay the foundation for response and remediation of any observation.
Our approach centers on the creation of a plan that is approved by the regulators and builds trust by showing evidence of execution at a pre-defined basis. Solutions are viewed from a systematic perspective and problems are solved holistically.
We understand that each client is unique but our experience has shown that there are often common solutions to observations that preclude having to “re-inventing the wheel” while also delivering services in a financially responsible manner. The following are some of the common services that are requested by our clients.
- Rapid assessment and Quality Improvement Plans
- Regulatory response submission and meeting support
- Regulatory audit responses
- Warning letter and remediation
- Consent Decree Support
- Import and Export Ban
- People Training
- Quality Culture transformation
Our rapid assessment program and quality improvement plans can lay the foundation for responding and remediating any observation.
Biosimilar and Regulatory Submission Strategies
We believe that the success of company in biosimilars is dependent on well-conceived strategy coupled with a solid regulatory plan.
It should take into consideration both global and local markets. This is specially important to plan based on the convergence of regulatory expectations of local and global regulatory agencies.
Significant cost savings can be achieve by developing a strategy with :
- Competitive landscape
- Multi-faceted product selection model
- Pricing implications for being second or third entrants
- Facility over-design and capacity modeling
- Understanding partnership(s) and negotiation levers
- Financial models to look at evaluate multi-variable scenario
We help companies develop a fully integrated strategy to support long term plans. The strategy includes portfolio assessment, capacity analysis, financial projection and schedule, market analysis, regulatory submission approach, Cost of Goods evaluation, Make-Acquire assessment and facility conceptual design
Regulatory Submission Strategy
BioSciencesCorp offers expertise so companies can evaluate their regulatory strategy and pathway before spending money without knowing what regulators want. Our strategies begin with advice directly from the regulators that provide sponsors with clear direction on their development and clinical requirements.
Biosimilars are highly competitive market and many companies are racing to launch product.
As a second or third entrant to the market the impact to pricing could be up to 50%.
We can help model this impact as part of a strategic plan which allows for a more realistic financial assessment.
Manufacturing Support & Process Metrics & Efficiencies
Operational Excellence and Quality by Design focus are critical to ensuring an operating facility operates at the highest level of efficiency
BioSciencesCorp has experts in biotechnology and manufacturing with capability to support all operational aspects of a new facility. Our team members come with 10-25 years of experience which allows them to tackle most issues found in an existing facility.
The team is composed of cross-functional members from Quality, Manufacturing, Engineering, Facilities, Validation, Manufacturing Information Systems, Regulatory,and Utilities. Our experienced executives are capable in the implementation of proven solutions. The following are some of the categories of offerings we can provide:
- Right First Time
- Operating Governance and Metrics
- Process optimization and waste reduction
- Quality by Design remediation and implementation
- Method Transfer
- Product Transfer
- Supply Chain optimization
- Vendor and Lab Audit
- Data Integrity and Part 11 Assessments
- Packaging Inspection Kits, Equipment and Inspector certifications
- Pre-FDA audit assessment and readiness plan
- Re-validation plan and execution
- New product introduction Planning
Operational excellence and Quality by Design elements are key to having a facility inspection-ready while running at the highest level of efficiency.
The BioSciencesCorp team supports and creates an operational framework to balance operational speed with highest quality standards.
Packaging Services & Visual Inspection Kits
Our laboratory is ISO certified and we can develop defect kits and train your inspectors. We can also generate automated machine testing kits that allow set-up and validation of your equipment. We have distributed these kits to the top 10 pharmaceutical companies in the world.
Our company, along with our partners, provide a full defect library that comes certified which can be used to support either manual inspection programs or help with the set-up and calibration of automated inspection machines. Our standard kit is designed to follow industry standards and is used by the top 10 biotechnology companies in the world.
- Packaging Inspection Kits
- Packaging Inspectors Certification
- Existing Inspection Kits assessment and certification
- Defect library for new visual inspection equipment
- Manual vision inspection program certification and effectiveness assessment
- Particulate Investigation and Identification
- Inspection SOP and AQL Authoring
Particulates found in biologics have been shown to impact PATIENT SAFETY.
Manual and Visual Inspection robustness is key in ensuring products are not released that can lead to patient safety issues and costly recalls.
Our company can provide the full complement of kits, training and programs to show regulators the effectiveness of your inspections.
New Facility Start-Up-Commissioning & Validation
BioSciencesCorp has industry experts who can assist throughout the entire life cycle of a new facility or major additions. Our team can help your organization with the initial concept, modeling capacity and schedule, selection of engineering firms, implementing the Quality by Design concept from the very beginning. We can assist your team in the development of equipment user requirements, equipment procurement, vendor negotiation, factory acceptance testing and the installation and validation.
Our care, custody and control methodology ensures all equipment is properly installed, documented, and safe and ready for validation and operation. The combined commissioning, qualification, validation and operational readiness models provide for a rapid process to enable facility commercialization. The results are the creation of a regulatory package ready for pre-approval inspection.
Start-up and Commissioning
We have a team ready to support start-up, commissioning,and validation of your new facility. We can provide a fully integrated plan and commissioning template ready to implement on your project. We also have developed master validation plans and protocols that can be adapted for your equipment and facility.
The following highlights key areas of focus:
- Quality by Design and GMP support
- Quality from start and keeping the end in mind
- Regulatory Design package
- Package created for regulatory review prior to finalizing design
- Automation strategy and development
- Construction and equipment sequenced to reduce cost and optimize resources
- Care, Custody and Control program
- Documented turn over packages and as built drawings
- Facility Start-up, Commissioning, Qualification and Validation
- Integrated approach to reduce validation effort and optimize schedule
- Product and Tech Transfer
- Development of plan and sequence for introducing products into new facility
- Operational readiness
- Start-up and commissioning
- Full Validation from equipment and processes
Our integrated commissioning, qualification, validation and operational readiness models expedite the facility commercialization process. The result is the creation of a regulatory package ready for pre-approval inspection.
Immunogenicity & PK/PD Methods and Testing
Our company, together with our partners can provide a fully validated method ready for transfer within 6 to 12 weeks. We have provided validated packages to support biosimilar programs Pharmacokinetics, Immunogenicity, Biomarkers and Antibodies testing to top biotech companies. CROs also use our packages to test samples for clinical trials support.
We offer a wide range of services with a focus on ready to transfer validated methods for global regulatory submission. The package includes documentation of all the testing conducted with the reference product and ready for biosimilarity comparison with target product. Currently we have over 20 biosimilar packages ready. The following are the sample services that we can provide.
Early Immunogenicity Indicator patented technology to simulate clinical results
Biocomparability Testing Validated Package
Fully validated biocomparability solutions for biosimilar testing ready for tech transfer or we can conduct testing at our sites
Bioassay Method Validated Package
The package provides fully documented and ready for tech transfer cell-based assays to test cell proliferation, cell viability, cell signaling, receptor activation, and ligand binding assays to measure various downstream proteins.
Antibody Functionality Validated Packages
Validated Packages are available for:
- ADCC assays
- CDC assays
- Fc Receptor binding assays, i.e, FcγRI(CD64), FcγRII(CD32a), FcγRIII(CD16a) and FcRn, etc.
- C1q binding assays
Immunogenicity is the most important safety element of a biosimilar program. We have developed validated methods that are ready to be transferred to your laboratories. Our package is being used by top 10 CRO to support clinical testing.
High Titer IND Ready Molecules
Together with our partners, using newly patent-pending technology, we offer a fully developed high yielding biosimilar molecule with titer ranging from 2-5g/l.
Our pipeline currently includes the following candidates.
The molecules highlighted in RED are under development and can be transferred with QTPP, CQA,CPP, Analytical similarity (3 lots) and FDA advice within 3-12 months after signing contract.
Biosimilar Clones and development process is the key to accelerating and commercializing your Biosimilar program. Our team has developed a global regulatory package with defined Critical Quality Attributes, Critical Process Parameters, fully characterized process, FDA advise package and with titers in excess of 2 g/L ready at 50L scale ready to be transferred to your manufacturing facility.