BioSciencesCorp
BioSciencesCorp specializes in end-to-end biologics solutions, offering expertise from molecule selection to full commercialization. The company has a deep experience team in biologics and biosimilars, providing support at every development stage with a focus on regulatory compliance, manufacturing support, process efficiencies, and quality systems. Their mission is to facilitate biologics and biosimilar development with a comprehensive approach, leveraging industry expertise to accelerate product readiness and market entry.
Industries
Nr. of Employees
small (1-50)
BioSciencesCorp
Products
Packaging inspection kits and certified defect libraries
Certified kits and defect libraries for syringes, vials and cartridges designed to support manual inspection programs and calibration/validation of automated inspection equipment.
Validated immunogenicity, PK/PD and bioassay method packages
Complete validated assay packages for immunogenicity, PK/PD and cell-based bioassays including documentation suitable for tech transfer and regulatory submissions.
High‑titer cell line and process transfer packages
Characterized cell line and mid‑scale process packages with defined QTPP/CQAs, CPPs and multi-gram-per-liter production at small scale, prepared for transfer to client manufacturing sites.
Packaging inspection kits and certified defect libraries
Certified kits and defect libraries for syringes, vials and cartridges designed to support manual inspection programs and calibration/validation of automated inspection equipment.
Validated immunogenicity, PK/PD and bioassay method packages
Complete validated assay packages for immunogenicity, PK/PD and cell-based bioassays including documentation suitable for tech transfer and regulatory submissions.
High‑titer cell line and process transfer packages
Characterized cell line and mid‑scale process packages with defined QTPP/CQAs, CPPs and multi-gram-per-liter production at small scale, prepared for transfer to client manufacturing sites.
Services
Consulting to assess regulatory observations, prepare submissions and remediation plans, and support regulator interactions and meetings.
Strategic planning for biosimilar product selection, market analysis, regulatory pathway evaluation, and submission preparation including FDA/EMA interactions.
Project support from concept through validation and operational readiness including equipment procurement oversight, commissioning templates, and master validation plans.
Operational excellence interventions including process optimization, automation strategy, operating governance, metrics, and supply chain optimization.
Provision of validated analytical and cell-based bioassay methods with documentation ready for tech transfer and regulatory submission support.
Development and supply of defect libraries and inspection kits for manual and automated visual inspection, plus inspector training and certification programs.
Consulting to assess regulatory observations, prepare submissions and remediation plans, and support regulator interactions and meetings.
Strategic planning for biosimilar product selection, market analysis, regulatory pathway evaluation, and submission preparation including FDA/EMA interactions.
Project support from concept through validation and operational readiness including equipment procurement oversight, commissioning templates, and master validation plans.
Operational excellence interventions including process optimization, automation strategy, operating governance, metrics, and supply chain optimization.
Provision of validated analytical and cell-based bioassay methods with documentation ready for tech transfer and regulatory submission support.
Development and supply of defect libraries and inspection kits for manual and automated visual inspection, plus inspector training and certification programs.
Expertise Areas
- Biosimilar development strategy
- Regulatory submission planning and remediation
- Biologics process development and scale-up
- Analytical method development and validation
Key Technologies
- Cell line development and clone selection
- Mid-scale bioprocessing (10–50 L) and tech transfer
- High-titer upstream expression platforms
- Cell-based bioassays (ADCC, CDC)
News & Updates
Discussion on biosimilar consulting strategies in Asia.
Comparison of FDA inspection methodologies for international firms, focusing on data integrity and laboratory systems.
Guidance on procurement and process development for biosimilar cell lines to save costs.
Explanation of the importance of testing at least 10 lots for biosimilar analytical similarity.
Summary of FDA draft guidance on biosimilar interchangeability.
Discussion on FDA's role and approach towards biosimilar approval and regulation.
Discussion on biosimilar consulting strategies in Asia.
Comparison of FDA inspection methodologies for international firms, focusing on data integrity and laboratory systems.
Guidance on procurement and process development for biosimilar cell lines to save costs.
Explanation of the importance of testing at least 10 lots for biosimilar analytical similarity.
Summary of FDA draft guidance on biosimilar interchangeability.
Discussion on FDA's role and approach towards biosimilar approval and regulation.