Advanced therapies have the potential to revolutionize patient care as a leading CDMO White Raven is uniquely positioned to meet the intricate fill-and-finish requirements of these transformative therapies thanks to advanced technologies in a Gloveless Robotic Aseptic Filling work cell.

We are an agile Fill & Finish CDMO specialized in GMP formulation and aseptic filling for small to medium-sized batch injectables.

As industry professionals, we were aware of the growing demand for smaller batches of sterile injectables, and the persistent issues that emerging biopharma companies face while looking for a suitable F&F partner. We started White Raven as a response to this increasing demand looking to fill that gap and reassure the biopharma companies to get their drug products in time to the market. Therefore, we focus on our core competencies: Formulation and Aseptic filling of liquid injectables.

There are multiple advantages a biotech might get from working with us such as:

1. Time efficiency, after signing your contract we are committed to delivering the client's batch in no more than 4 months.
2. A fully robotic single-use aseptic filling process that reduces manufacturing andcontamination risks and optimizes filling efficiency.
3. We are completely adherent and adapted to the updated EU Annex-1 standards.
4. Flexibility: Our state-of-the-art equipment allows to offer our clients a high degree of flexibility, both in terms of container types and accessibility to a production slot in a limited amount of time.
   

Due to our ability to have agnostic offerings appropriate for a wide range of molecule types, small molecules, peptides, biologics, viral vectors, mRNA, and other ATMPs, we work with emerging biopharma companies and established commercial pharmaceutical companies. Our batch size ranges from a few 100 units to 20,000 units per batch making this a suitable range to cover both clinical and smaller commercial demands.

Any biopharma company or cosmetic company looking to outsource its drug product manufacturing when it comes to liquid injectables can find a suitable partner in White Raven.

Due to our strategic location in Belgium, we have identified the European injectables market as the primary market to implement our services. Subsequently, the North American and other key markets or growing market territories will be assessed for the future growth and expansion of White Raven’s filling solutions.

We offer mainly two types of services:

• Formulation Services: We specialize in providing superior pharmaceutical formulation services that cater to a broad spectrum of industry needs. 
  Check the following link for more information: Formulation Services.

• Aseptic Filling Services: We provide state-of-the-art fill-and-finish services tailored to your manufacturing needs meeting the standards of the pharmaceutical industry. 
  Check the following link for more information: Aseptic Filling.
  

This is dependent on the filling volume and container size, for example, filling 1 mL in 2mL (2R) vials will go as fast as 1800 vials/hour (implementing 2% IPC). Taking this filling speed into account, we’re able to process most batches in a singular day.

We provide comprehensive packaging and labeling solutions that can be customized to meet the specific requirements of our clients.

• Biologics
• Gene therapies
• mRNA
• Potent compounds
• mAbs
• Peptides
• Oligonucleotides
• Small Molecules
• Hyalorunic acid-based solutions
  

Packaging & Labeling: Besides our core services of aseptic filling, formulation, and visual inspection, we offer a complementary packaging & Labeling service designed to ensure your products are securely and efficiently packaged and easily identified.

Yes, as we’re a startup we have (more or less) a blank space when it comes to production scheduling allowing us to bring promise to our offering of flexibility. Keeping this in mind we don’t intend to have a fully booked capacity to make sure we keep the production flexible throughout the year. 

Only by doing so we can anticipate unexpected delays from our client’s side while not hindering or postponing scheduled productions.

The equipment allows us to use Ready-To-Use (RTU) components, this encompasses polymer & glass vials (2 to 50 ml), polymer & glass syringes (1 to 20 ml), and cartridges (1.5 to 20 ml).

Our Quality By Design (QBD) and risk management approach includes working with a fully single-use pathway from formulation to and including the filling step. This approach significantly reduces the risk of cross-contamination and allows us to have a flexible and quick turnover between projects.

In addition, using a robotic and gloveless isolator we eliminate the human interaction during the filling operations which we eliminate the chance for any human error.

Currently, more than 60 of the SA25 robotic filling equipment have been sold and are producing commercially available drug products. Drug products filled on aseptic filling work cells have been approved by four regulatory agencies to date: FDA, Health Canada, Singapore PIC/S and cNMPA.

The equipment is designed to be fully EU-Annex-1 compliant and White Raven is proud to be on track to be the first company to offer EMA-approved drug products using Cytiva' SA25.

We have strict confidentiality policies and secure processes in place to protect our client’s intellectual property, including non-disclosure agreements (NDA), Master Service Agreements (MSA), and Quality Agreements (QA) with clients.

Our confidentiality policies are designed to protect client information rigorously. This includes NDAs, secure data handling practices, and restricted access to sensitive information.

We use a market-competitive pricing approach and can provide you with a budgetary quotation based on the criteria of parameters set out in our technical questionnaire.

Our T&Cs are outlined in our MSA contract which is a fundamental document used for any future work or services that might be provided.

The MSA will include a Statement Of Work (SoW) that outlines a particular project or service including timelines, deliverables, and pricing.

As we understand the budget constraints for start-up or emerging biopharma companies, we are open to discussing commercial incentives that might make our services available to our clients.

Our state-of-the-art facility is strategically located in the heart of European pharma in Liège, LégiaPark, Belgium.

When it comes to handling your drug substance and drug product logistics and supply chain management are of critical importance, therefore we have established a network of partners with extensive industrial expertise to assist us in supply chain operations.

"We stay current by investing in continuous training, attending industry conferences, and incorporating the latest technologies and methodologies in our processes."

We understand that the landscape of biopharmaceutical modalities keeps evolving, and so do their corresponding filling requirements. Therefore, it’s of utmost importance to us to keep listening and conversing continuously with our clients, partners, and industry peers to understand these changes and make sure we retain the high-quality standards.