DQV Bio Projects
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Project 10
DQV Bioanalytical is currently retained by a Washington, D.C.-based consulting firm to provide Analytical SME support to a New York-based cell therapy developer. DQV Bioanalytical was retained specifically due to expertise and experience with visible particles in parenteral biotherapeutics. Responsibilities included:
• Review and assessment of Visual Inspection program and procedures for product manufacturing
• Review of historical Visual Inspection and particle characterization data
• Summary of estimated patient safety regarding visible particles for current lots via comparison with pivotal clinical lots
• Support revising program documentation to include annual review detected visible particles and associated patient safety assessment -
Project 9 (Active)
DQV Bioanalytical is currently retained by a Washington, D.C.-based consulting firm to provide CMC and Analytical SME support to a Florida-based vaccine developer. Support activities include:
• Propose reference standard program, including document generation
• Manage assay transfer/re-validation to international CDMOs
• Provide analytical SME to Quality, Operations, & Regulatory teams -
Project 8
DQV Bioanalytical has been retained by a Washington, D.C.-based consulting firm to support CMC due diligence assessment of potential assets for future development. Support includes:
• Review available preclinical, clinical, regulatory, and CMC documentation to assess IND-readiness
• Identify risks/gaps and propose mitigating strategies
• Provide detailed assessment of asset analytical package -
Project 7 (Active)
DQV Bioanalytical is currently engaged by a clinical-stage bacteriophage therapeutic developer to support the growth of the Analytical Development department within the current Quality System. Activities include:
• Develop AD quality infrastructure workflows and SOPs
• Draft support documentation for Process and Analytical Control Strategies
• Draft and review method qualification
• Manage external CTL method qualification
• Provide SME for HCP quantitation by LC-MS/MS -
Project 6
DQV Bioanalytical is currently engaged by a Maryland-based cell therapy startup to support the AD/QC activities. Support services include:
• Develop LC-MS from initial ask through qualification
• Support LC-MS installation and training
• Coordinate product characterization by CTLs for comparability study
• Support general analytical method development and qualification
• Draft and review Standard Operating Procedures, Qualification Protocols, and Technical Reports -
Project 5
DQV Bioanalytical was engaged by a Maryland-based vaccine development company supporting technology transfers to external laboratories. Support services included:
• Developed project milestone in alignment with client timelines
• Guided cross-functional teams through project with transparent communication
• Addressed challenges as the arise during transfer execution through internal and external collaboration -
Project 4
DQV Bioanalytical was retained by a Maryland-based biotechnology startup for assistance in purchasing a new high resolution mass spectrometer. DQV Bioanalytical’s responsibilities included:
• Leveraged previous experience and SME to identify to best MS models
• Connected client to local MS vendors
• Supported on-site team in preparation of lab space for MS installation -
Project 3
DQV Bioanalytical was engaged by a Chinese Cell & Gene Therapy company to assist in:
• Support analytical control strategy for C> products
• Identify appropriate release methods as well as novel methods for C> products
• Map logistics systems and draft SOPs for Analytical Development
• Draft GT facility design review package to share with the Chinese NMPA -
Project 2
For a Maryland-based biotechnology startup, DQV Bioanalytical assisted in the identification of a CDMO partner for antibody production. DQV Bioanalytical’s responsibilities included:
• Screening and pre-qualification of CDMOs from a global list
• Development of Request for Information and Request for Proposal packages
• Candidate evaluation based on scoring proposals and pitch meetings
• Assist in candidate selection and award -
Project 1
Retained by a US-China joint venture (JV), DQV Bioanalytical led a cross-functional team of facility designers and antibody-production experts to generate a facility design package to share with the Chinese government. DQV Bioanalytical’s responsibilities included:
• Consolidate drawings and reports into single package (report and presentation)
• Coordinate cross-functional multi-national team
• Lead effective virtual meetings across multiple time zones
• Assist in agency meeting prep and attend virtually supporting presentation team
What People Are Saying
“Natalie was engaged to support our phage research team in the selection of a new mass spectrometer based on our needs. She researched available models and provided a clear and concise comparison to facilitate decision making. She connected us with the local vendor and provided support during site preparation. In addition to instrument selection and support, Natalie worked with the team and CROs in the characterization of our phages assisting with experimental design, data analysis and interpretation, and presentation to the Scientific Advisory Board. Natalie approached each challenge with the focus of a subject matter expert while maintaining the perspective of a biotech professional. Natalie’s organization and communication skills lead to a successful presentation to the SAB. I highly recommend her given her deep and broad technical abilities, pragmatism, attention to detail, perseverance and positive collaborative style.”
— Michael Boychyn, SVP Technical Operations
“Natalie was engaged by [the JV] to coordinate the first meeting with the Chinese FDA (NMPA) in their local Hangzhou office. Due to COVID, all meetings were virtual. Natalie managed a very large team from both JV partners exceptionally well. Besides dealing with corporate functions, she was also coordinating local input in the requested documents and presentations. Natalie’s collaboration and leadership skills enabled her to run short and very efficient virtual meetings. Her technical skills and subject matter expertise persuaded all project members to deliver expected inputs on time. The meeting with NMPA was after all her preparation a very solid success. I was personally impressed how she delivered in a complex environment and without having personal connections to team members.”
— Group VP Asia Strategy Pharma Services
“Natalie Thompson demonstrates true professionalism in our interactions. She is a seasoned biotech technical expert. She is not only familiar with the technical requirement in supporting what we needed, but also have the sophistication in understanding the operational related issues. She is a very strong communicator, both in verbal and in writing. Her organization skills is also exceptional. It was not easy to work across globes with multiple time zones and two dozen people involved. Natalie is also punctual and sensitive to the delivery time and hosting meetings with the uttermost efficiency. Throughout of the project, Natalie was always on time on delivery with high quality presentations and write ups. It is a true pleasure to have Natalie on the team. We will do this again.”
— Vice President of Cell and Gene Therapy Product Development
“Working with Natalie (DQV Bioanalytical) was an excellent experience. Natalie worked with my team as a technical project manager providing much needed project management skills to a heavily technically minded effort. Natalie's ability to communicate with both technical and business acumen allowed us to create a successful partnership between teams leading to successful transfer and implementation of several analytical methods.”