Services

We have successfully led development activities on numerous projects from the identification, development and implementation of manufacturing processes for biologics - Monoclonal Antibodies (mAbs)​, Microbial Fermentation, & Cell & Gene Therapy.

• Developed, transferred and scaled-up engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation, and other chemistries.
• Led the purification of secreted proteins in yeast from high solids fermentations.
• Completed process characterization studies and process validations for registration and commercialization of a monoclonal antibody and tech transferred into multiple CDMO's in record time.
• Led technology transfer of critical raw material assay and subsequent investigation and resolution of a long-standing issue for marketed monoclonal antibodies.
• Authored and reviewed biological drug substance sections of regulatory submissions for BLAs/MAAs and INDs/IMPDs.

We have successfully led development activities on numerous projects for small molecule drug substances from the identification, development, and implementation of manufacturing processes.

• Led development and implementation of synthetic processes for the manufacture of multiple APIs.
• Delivered API supplies for toxicology and clinical trials (up to Phase 3) - for diverse therapeutic targets such as metabolic, infectious diseases, and oncology.
• Identified and developed synthetic routes for rapid scale-up for laboratory-based manufacture of API for clinical supplies.
• Conducted successful technical transfer and validation of commercial manufacturing processes.
• Applied Quality by Design (QbD) principles to drug substance synthesis.
• Authored and reviewed drug substance sections of regulatory submissions for BLAs/MAAs and INDs/IMPDs.

Verta Life Sciences consultants have experience developing drug products in all dosage forms using a variety of technologies.

• Scaled-up and Tech Transferred aseptic fill/finish manufacturing for multiple sterile products including vials, ampules, and pre-filled syringes.
• Designed solid dose form using process design and optimization for multiple tablet, hard and soft gel capsules products.
• Led inhalation product development and scale up for clinical and commercial supplies
• Managed scale-up and troubleshooting during clinical trials/regulatory batch production for solid dose products manufactured using Blending/Granulation/Drying.
• Reviewed methodology, support process trials and tech transfer for products using Suspension/Bead Milling.
• Reviewed facilities and produced equipment rationalization paper for mixing, granulating and FBD processing worldwide.
• Authored and reviewed drug product sections of regulatory submissions for BLAs/MAAs and INDs/IMPDs.

Analytical methodology is critical to the drug development process from drug discovery to post-approval. We have the experience developing analytical methodology for all phases of product development.

• Implemented automation for complex analytical testing for inhalation products and successfully led tech transfer of these platforms to manufacturing sites.
• Developed a robust risk-based approach to qualify and release test over 90 new raw materials for semi solid topical products over an 18- month period.
• Completed multiple analytical method transfers and validation applying QbD principles.
• Authored stability study protocol to ensure alignment with ICH and market-specific regulations.

On behalf of our clients, we work with contract manufacturers worldwide to ensure the successful development, tech transfer and supply of APIs.

• Led the entire CMC program for a potential monoclonal antibody COVID treatment.
• Rapidly scaled-up, tech transferred, and managed the selection and management of 7 CDMO's involved in BDS manufacture, DP fill finish, and clinical packaging.
• Conducted due diligence review, contract negotiation, tech transfer management, new product launch planning on behalf of numerous clients.
• Led a review of the manufacturing and supply strategies being implemented by 11 different CDMO's to ensure the secure and affordable supply of the clients products.
• Negotiated supply, technical transfer, master service and development agreements for numerous clients with product in per-IND phase through to commercial supply.

Our consultants have managed operational logistics activities from new drug investigation through commercial launch for numerous clients.

• Directed a supply chain program that impacted 151 markets and 99 manufacturing sites in 39 countries. Instrumental in delivering $1.8 billion in annual savings.
• Conducted numerous sourcing activities to identify, select, onboard and manage LSP’s best suited for client needs.
• Re-routed client’s international supply chain resulting in reduction in clearance and overall shipping times, reduction in risk of loss, and reduction in costs by 50% per shipment.
• Implemented new warehousing strategy to improve delivery times to customers and for business continuity.
• Lead and provided oversight for a high volume national medical aesthetics  manufacturing operation.
• Implemented a global trade compliance solution minimizing risk and saving $50M in first year through duty  optimization in a major pharmaceutical company.

We have worked on over 100 new product launches that included both primary and secondary package design, as well as new product  logos and production artwork.

• Established end to end package design, development and qualification processes for consumer and pharmaceutical products
• Created packaging design for all types of dosage forms.
• Lead serialization implementation for Specialty Care products through collaboration with partners and their CMOs.
• Created artwork for multiple products in including pack design, prescribing and patient information insert and outsert design, editing and proof reading in english and other languages.
• Directed serialization project, including MDM and ERP system for a major gene therapy company.

In response to increasingly stringent regulatory requirements, we provide comprehensive quality management support.

• Developed and implemented phase appropriate quality management systems for multiple development companies.
• Implemented and performed quality system remediation activities including quality system redesign of document control, change control, investigation, and complaint systems.
  
• Conducted GMP, GLP, GDP, and Global Clinical Quality audits globally for clients.
• Provided quality oversight of contract manufacturers, alliance partners and subsidiaries from initiation of commercial manufacturing to termination of relationship.
• Acted as a liaison during regulatory inspections (i.e., general inspections, pre-approval inspections, and site inspections). Coordinated written responses to any comments/observation. Coordinated product recalls and provided FDA with periodic status reports.
• Acted as Japan quality lead for Medical device and Alliance relationship.
• Acted as China quality lead for multiple products.