What is Pharmaceutical Pilot Scale-up?

Pharmaceutical pilot scale-up is the process of increasing the production of a pharmaceutical product from laboratory-scale to pilot-scale in order to achieve a larger quantity of the product for testing and evaluation. This process is crucial in the drug development cycle allowing pharmaceutical companies to assess the scalability of the manufacturing process and identify any potential problems that may arise during full-scale production. Therefore, proper execution of pilot scale-up is essential for ensuring the success of a pharmaceutical product in the market and meeting the growing demand for effective and safe medications.

Explore Our Pharmaceutical Pilot Scale-up Services

As a contract development and manufacturing organization (CDMO), CD Formulation provides unparalleled pilot scale-up services for the development of oral solid and liquid, semi-solid, and injectable formulations, including but not limited to tablets, capsules, granules, patches, ointments and complex injections.

We have the ability to provide you with services from small-scale trial production to medium-scale mass production to ensure the stability and consistency of the formulation. Whether it is initial production or mass production, we can provide you with fast and efficient service to ensure that the quality of your drugs reaches the highest standards and help you achieve a successful launch of your products.

CD Formulation provides pharmaceutical pilot scale-up services at competitive prices, including but not limited to:

• Confirmation of quality attributes of API and excipients.
• Identification of critical process parameters (CPPs) and critical quality attributes (CQAs).
• Advanced strategies based on Quality by Design (QbD) principles and Design of Experiments (DoE).
• Sterilization process selection and process development.
• Selection and identification of packaging materials for sterile products.
• Manufacture of oral solid and liquid dosage forms under CGMP-compliant conditions.
• Drug product batches for toxicology and stability studies.
• Define the target product profile (TPP) related to quality, safety, and efficacy.

What Problems Can Our Pharmaceutical Pilot Scale-up Services Solve?

• Ensuring the product can be reliably and consistently manufactured on a larger scale.
• Identifying and addressing any potential manufacturing challenges or issues early on.
• Optimizing the manufacturing process to improve efficiency and reduce costs.
• Meeting regulatory requirements for scale-up and production.
• Conducting validation studies to ensure the product meets quality standards.
• Providing a smooth transition from small-scale development to full-scale production.
• Increasing production capacity to meet growing demand for the product.
• Improving product quality and consistency.
• Minimizing risks associated with scale-up by conducting thorough testing and evaluation.
• Helping to accelerate the timeline for bringing a new product to market.

Why Choose CD Formulation for Pharmaceutical Pilot Scale-up Services?

• Comprehensive integrated CGMP supporting analysis services support the development of multiple dosage forms, including but not limited to tablets, capsules, granules, oral liquid preparations, and complex injections.
• Always at the forefront of innovative drug delivery system development and drug analysis.
• World-class facilities and equipment.
• Provide integrated services from early-stage formulation development to full commercial CGMP manufacturing.
• Professional technical support and consulting services to help customers achieve their drug development goals.
• Reliable delivery and production schedules ensure customers can launch products on time.
• Cost-effective and competitive prices.

CD Formulation's pharmaceutical formulation development will be customized based on your specific pharmaceutical active ingredients (API) and target product profile. Please contact us today for your exclusive solution.