Supporting your product's journey to market.
Our comprehensive registration activities, includes preparing and submitting NDA/BLA regulatory filings to streamline your approval process.
- NDA/BLA submission
- Batch manufacture and stability
- Analytical support (dissolution development / risk assessments)
- Process optimisation robustness (Qbd, DoE)
- Method validation
Technology Transfer.
Our team of experts can support you in all aspects of scale-up and technology transfer through our state-of-the-art development and manufacturing facility.
With knowledge across all layers of our business, we ensure a seamless transfer and reduced risk of advancing into later stages.
Project Management.
Our project teams are made up of subject experts from across our business, so you know you’re in good hands.
We provide an open dialogue to provide full transparency of project delivery, ensuring your scale-up and technical transfer requirements run smoothly.
We're here to help.
If you’re looking to work with a CDMO with extensive experience in technical transfer, scale-up and registration activites, then we’re here to help.
Speak to our team to discuss your requirements.
Frequently Asked Questions
What are some common strategies used to optimize efficiency and productivity during process scale-up in pharmaceutical manufacturing?
During process scale-up, common strategies used to optimise efficiency and productivity include conducting thorough risk assessments to anticipate potential challenges, leveraging automation and advanced technology for accurate measurements and data analysis, optimizing equipment design for scalability, implementing continuous improvement practices, and ensuring clear communication and collaboration among cross-functional teams involved in the scale-up process.
What are the advantages of using spray drying in pharmaceutical formulations?
Spray drying offers several advantages in pharmaceutical formulations, including precise control over particle size and distribution, improved solubility of poorly soluble drugs, enhanced bioavailability, ease of scale-up, and versatility in producing various dosage forms such as powders, granules, and microspheres.
What types of pharmaceutical products can be produced using spray drying?
Pharmaceutical spray drying can be used to produce a wide range of products, including inhalable powders for pulmonary and nasal delivery, solid dispersion systems (SDDs) to improve drug solubility, modified release formulations for controlled drug release, and stable formulations of biologics.
