Product Development

Whether it is for early concept, feasibility, characterization, pre-formulation, formulation development, formulation optimization, DoE’s, process development, our dedicated formulation and process development scientists with 100+ years of cumulative experience can handle complex and diverse soft capsule formulations.

We safeguard your product supply by achieving the established quality target product profile, reducing process variability, and by consistently complying to regulated market requirements. Capcium supports development of new and generic (existing) product pipelines.

Sourcing

In today’s competitive market environment, Capcium has learned that improving supply chain performance is critical to maintain competitive advantages.

Forecasting, planning, procurement, financing, stock levels, and marketing strategies are some of the areas in which we have to take decisions, and balance their inter-related effects simultaneously, to achieve Capcium’s organizational goals.

Procurement at Capcium is thoroughly scrutinized, and we have become more cautious of raw material and service spending. We evaluate different suppliers, who can fulfill our requirements at a lower cost, with attention to overall spending and quality requirements.

We aim to ensure savings are measurable and sustainable – delivering greater value for Capcium over the long term.

Quality Assurance

Our quality team works closely with our R&D department, manufacturing and packaging operations, engineering, supply chain, vendors, and our customers to ensure we are compliant throughout the product lifecycle from development to commercialization to product discontinuation.

Our robust quality management system meets the highest regulatory standards and include management of non-conformance, CAPA, document, audit, training, complaint, compliance, change, vendor, and risk. Capcium quality control laboratory ensure that the incoming materials and final product meets the specifications set forth.

Analytical Services

Capcium is rapidly expanding its services and team to support formulation development areas.

Its fully equipped cGMP/GLP state-of-the-art laboratories provides the analytical development support for your softgel oral dose product. Method development, method validation, stabity testing, incoming raw material testing and release of final oral dose form.

Analytical Method Development & Method Transfer

Capcium’s analytical development team is highly experienced in supporting analytical method development or transfers suitable for assessment of the quality of products. The analytical procedures include:

Analytical Test Method Validation

Capcium’s team expertise ensures that all work is carefully planned during the test method validation process, and performs all the necessary steps providing precise, accurate and robust results specific to the dosage form.

Capcium assess the validation characteristics of accuracy, precision, repeatability, intermediate Precision, specificity, detection limit, quantitation limit, linearity, and range.

Research & Development

Capcium offer integrated end-to-end clinical to commercial stage development services. From feasibility studies, formulation development, design of experiment trials, tech transfer, scale up, to process characterization, we have the capability and knowledge to advance your discovery or idea into a commercial product for the end customer. Our fit-for-purpose phase appropriate development services cater to pharmaceutical, dietary supplement and cannabis pipelines.

Capcium maintains one of the rare soft capsule formulation development labs to support your development projects.

cGMP Manufacturing Production

• Sanitary design stainless steel gel reactors with clean in place (CIP) capabilities. The reactors are mounted on the load cells and equipped with state-of-the-art controls for the variable speed agitators, precise temperature control and vacuuming capabilities.
• Sanitary design stainless steel gel reactors with clean-in-place (CIP) capabilities. The reactors are mounted on load cells and equipped with state-of-the-art controls for the variable speed agitators and homogenizer, precise temperature control and vacuuming capabilities.
• Sanitary design gel receivers, CIP-able jacketed stainless-steel tanks with temperature control
• Sanitary design fill receivers, CIP-able stainless steel tanks.
• Gel manufacturing capacity- 6 batches per day- size/complexity dependant
• Fill manufacturing capacity 6 batches per day- size/complexity dependant
• Colloidal Mill for wet milling applications- Milling speed 200-600 kg/hr product dependant
• Deaeration- up to 600 kg/hr- product dependant.
• Polishing and printing capabilities- product dependant.
• Screens and metal detectors in process where required