Our team has in-depth understanding of regulatory and market landscape in MENA, LATAM, Russia, APAC and India. This is complemented by our long relations with leading companies across the world who are keen to take a dive in Biotechnology or want to take the products to global level. Following are our areas of expertise:
- Portfolio and market entry strategy
- Finding the right partner for in-licensing/out-licensing from across the world
- Conducting technical due diligence
- Partner and agreement finalization
- Local clinical trials
- Regulatory submission
- Market assessment models
- Pricing models
- Launch planning
3 High Titer IND Ready Molecules / complete tech transfer/Innovator molecule procurement (RMP) from US/EU/ROW
Cell lines with process and FDA(EMA) advice + Tech transfer + RMP sourcing
Our expertise lies in providing the following 3 key aspects of product development:
- High titre (2-5 gm/litre) and very fast turnaround (within 12-15 months for 50 L process)
- IP clearance for global launches
- Complete de-risking of global development (by providing FDA/& EMA advise for clear strategic path)
Key focus areas:
Complete tech transfer support:
- DS tech transfer
- DP tech transfer.
RMP sourcing: Multiple lots with full traceability for regulatory filings
- From US
- From EU
1. Newer generation Oncology Monoclonal antibodies: second and third generation molecules which are future blockbusters and can be lined as first to launch global
2. Oncology: current blockbusters
3. Autoimmune: Current blockbusters
4. Autoimmune: future
We believe that the success of company in Biosimilars is dependent on well thought 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 & capacity modeling
- Understanding partnership(s) and negotiation levers
- Financial models to look at evaluate multi-variable scenario
We help companies develop 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.
Biosimilar is highly competitive space and many companies are racing to launch product. As second and third entrant to the market the impact to pricing could be up to 50%.
We can help model this impact as part of the strategic plan which allows for a more realistic financial assessment
Warning Letter and 483 Response Support
Our team understands that regulatory and compliance complexity that comes with operating a facility that is regulated in multiple markets. In our experience there come times when there are regulatory challenges that are highlighted by clients or global regulators. The management and responses to observations is crucial and requires a level of independence and systematic process. Our rapid assessment program and quality improvement plans can lay the foundation for responding and remediating 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-invent 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.
Manufacturing Support & Process Metrics & Efficiencies
Operational Excellence and Quality by Design focus are critical to ensuring an operating facility operates with highest level of efficiency.
BioScienesCorp has experts in biotechnology and manufacturing with capability to support all the operational aspects of a new facility. Our team members come with 10-25 years of experience that 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, Utilities with experienced executives that enable 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 element are key to having a facility Inspectional ready while running at highest level of efficiency. BioSciences team supports and creates operational framework to balance both 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 an automated machine testing kits that allows set-up and validation of your equipment. We have distributed this kits to 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 being 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 release that can lead to patient impact and costly recalls
Our company can provide the full complements of kits, training and program to show regulators effectiveness of your inspections.
New Facility Start-Up-Commissioning & Validation
BSC has industry experts that can assist throughout the entire life cycle of a new facility or major additions. Our team will help your organization with the initial concept, modeling capacity and schedule, selection of engineering firms, implementing 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 will ensure all equipment are properly installed, documented and safe and ready for validation and operation. The combined commissioning, qualification, validation and operational readiness models allow for a rapid process that enables 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, 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 facility commercialization process. The result is the creation of a regulatory package ready for pre-approval inspection.
Immunogenicity & PK/PD Methods and Testing
Immunogenicity & PK/PD Methods and Testing
Our company, together with our partners can provide a fully validated method and 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 and CRO 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 assay 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