Services

Launching an Advanced Therapy product is not an easy feat. Whether it is the first time or not, it is essential to bring in the best resources to build a robust long-lasting strategy. Having gone through many iteration cycles ourselves, we can support the design of an investor-friendly financial and technical strategy, rooted in Product Development sciences. Challenges will inevitably come up, but knowing how to deal with them is what will make your strategy long-lasting. 

Examples of Services include:

• Roadmap from Ideation all the way to Clinical and beyond

• Product Development Gap Analysis

• Key Partner Selection

• Financial Projections including:

  1. 1. Cost of Goods planification

     2. BOD Quarterly reports

     3. Product Development Budgets for Investment purposes

From Day 1, the Process should be top of mind as it will be the main driver of your COGs. Define your process with the end in mind: it will be executed in a cleanroom and therefore will be expensive. Our expertise in Process Development and Automation will allow you to define your scale-up/scale-out strategy for your autologous or allogeneic products and to find the best path forward to bring it from small scale all the way to clinical trial manufacturing. 

Examples of Services include:

• Establishment of QTPP and CQAs

• Process Scale-up

• Automation of Processes

• Closure of Processes

• Selection of Fit-for-Purpose
  Devices (Bioreactors, Upstream, Downstream etc.)

• Comparability Studies

• Troubleshooting of critical steps and attributes (viability, transduction, growth curves etc.)

Your product is only as good as the assays you will use to describe it. You will need to define your product carefully by using qualified assays. This is an expectation from any regulatory agency that will review your products. 

We developed an expertise in molecular biology, flow cytometry and cell-based assays that will support your efforts in defining your product's safety profile, its identity and its potency. 

Examples of Services include:

• Development of Test Methods

• Determination of Fit-for-Purpose, and basic standards (LLOD, ULOD etc.)

• Levy-Jennings charts, associated with Westguard rules for detection of drifts in methods

• Qualification and Validation protocols and reports

• Comparability Testing

Tech Transfers into a CDMO or an internal Manufacturing facility can be stressful. IND submission timelines are strict and increase the amount of pressure on all teams involved. But it does not have to be that way. Having worked in Biotech companies and at CDMOs, we have built experience in the art of a smooth, tension-free and more cost-effective tech transfer into a GMP setting. 

Examples of Services include:

• CDMO Selection & Contract Negotiation

• GMP readiness and Tech Transfer

• Analytical Method Transfer

• Generation of Master Batch Records

• Transfer into electronic BR systems

• Establishment of Bill of Materials

• Logistical Support

The GMP manufacturing of a clinical product is a difficult task. 

We developed expertise in GMP manufacturing of cell therapy products from both a Biotech standpoint and a CDMO standpoint. We understand the challenges of both sides, which allows us to drive an efficient relationship between client and service to reach the ultimate goal: a timely delivery of cell therapy products for as many patients as possible. 

Examples of Services include:

• Capacity Planning & optimization of slot occupation

• COGs Forecasting

• Clinical MFG Management

• Batch Record Review

• Sampling Plans & QC Release Management

• Analytical Test Form Review

• Timeline & Program Management

Whatever the stage your company is at, Quality should be at the centre of any activity. That way, you always keep an eye on the prize and avoid drifts.

We developed expertise in Quality of Cell & Gene therapy products over the last 20 years and can support your Quality needs every step of the way to ensure your Product moves switfly from one development stage to the next. 

Examples of Services include:

• Implementation of Quality Management Systems

• Contractor & Clinical site audits

• Paper & Electronic BR generation

• Generation and Review of Technical and Corporate SOPs

• Generation of Product related documentation (CofA, CofR, labels etc.)

• CMC Section writing

Once your process and analytical assays have been transfered and you have shown repeatability in the GMP setting, it is time to show the regulatory agency that your product is worth being presented to patients. The next step will be to submit your regulatory package (IND/CTA or else). We have a track record of many regulatory submissions done in a record time, as well as a clear understanding of what the agencies will expect from your package. We will be happy to support your team in the writing of the CMC sections for your next submission.

Examples of Services include:

• Process Development Reports

• Analytical Development Reports

• Tech Transfer Reports

• Process Flow Diagrams

• CMC Section writing

• CMC Program Management

• Support for FDA Module 3 and Health Canada Module 2

The clinical trial will teach you a lot about your product, but in order to trust the data you will be collecting, you need to establish a solid strategy from the get-go. Translational science is not trivial and it takes a lot of effort to be able to trust your product. 

We developed expertise in building a Translational program from the ground up: from the laboratory manual, to the logistics of sample planning, collection and processing, all the way to the final statistical analysis of your clinical biomarker data. 

Examples of Services include:

• Translational Planning

• Biomarker Strategy

• Analytical Platform Selection & Qualification

• Data Integration & Decision Frameworks

• Biostatistics Strategy and Implementation

• Regulatory Support