Catalent

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From Candidate to Clinic: Strategies to Select, Assess, Formulate, and Deliver the Right Drug Candidate in the Early Phase

A Data-Driven Approach to Overcome Bioavailability Challenges

	Catalent is the leading global provider of advanced drug delivery technologies and development solutions for drugs, biologics, and consumer health products. The company has over 80 years’ experience serving the pharmaceutical industry, and proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable product supply.

	Catalent’s solutions include analytical, pre-formulation and formulation technologies and expertise, and with the recent addition of spray dry dispersion specialist Pharmatek, it now offers further early development capabilities and the most comprehensive toolkit of bioavailability enhancing technologies. Catalent produces over 70 billion oral, sterile, biologic, and inhaled doses each year, for clients across five continents.

	Built on its experience in early phase development, which has seen the company support more than 500 INDs, Catalent has extended the scope of its multi-award winning OptiForm

 Solution Suite. This integrates multiple tools and services to deliver customised development programmes that provide innovators with a data-driven, key milestone approach and a thorough analysis of important drug molecule characteristics at each stage, including consideration of downstream processing and optimal dose design for the intended patient group, to improve the chances of success in both the clinic and beyond.

	Catalent. More products. Better treatments. Reliably supplied.

Catalent has the broadest range of technologies and solutions to overcome developmental and bioavailability challenges, and to enhance product performance.

Broad Technology Toolkit to Accelerate Drug Development

	From early phase development through to clinical manufacturing scale, spray drying can assist in overcoming formulation and development challenges.

	With the acquisition of Pharmatek Laboratories, Catalent now offers spray drying as part of its bioavailability toolkit, complementing its comprehensive suite of development and formulation solutions. Additionally, the expansion of development and clinical manufacturing capabilities strengthens Catalent’s ability to partner with customers earlier in pre-clinical development.

	Pharmatek’s San Diego facility expands Catalent’s global network of clinical and commercial manufacturing supply facilities, which integrates drug development and delivery for both oral and injectable dose forms. The site has the capacity to provide rapid development from prototype to optimal final dose form, with integrated characterization, analytical, pre-formulation, formulation, process development, and cGMP manufacturing. The facility has over 18,000 square feet of laboratory, manufacturing and support space dedicated to development and manufacturing of highly-potent compounds.

	Spray drying technology will now be incorporated into OptiForm® Solution Suite, Catalent’s award-winning screening platform, to assess optimal formulation pathways for the oral delivery potential of both small and large molecule drugs.

With the acquisition of Pharmatek Laboratories, Catalent now offers spray drying as part of its bioavailability toolkit, complementing its comprehensive suite of development and formulation solutions.

Spray Dry Technology for Pharmaceutical Development

	Catalent Pharma Solutions, the leading global provider of advanced drug delivery technologies and development, provides a broad range of inhalation solutions.

	From pre-formulation to commercialisation, Catalent integrates its experience in pre-formulation sciences, formulation development, device evaluation/selection, performance testing, chemistry, manufacturing and control (CMC), and manufacturing to reliably deliver dosage forms including:

	   •   Pressurized metered dose inhalers (pMDIs)
	   •   Dry powder inhaler (DPIs)
	   •   Nasal sprays
	   •   Solutions/suspensions for inhalation.

	The integration of Catalent Micron’s particle size reduction capabilities into the company’s development and formulation portfolio provides unique solutions in micronisation and classification of powders, meeting the tightest specifications required for inhalation products. These include:

	   •   Micronisation (jet mill)
	   •   Mechanical milling (hammer mill, pin mill)
	   •   Cryogenic milling
	   •   Potent and cytotoxic compounds
	   •   Comprehensive analytical services.

	For more than 40 years, Catalent has provided end-to-end solutions from its inhalation manufacturing operations in RTP, North Carolina, and Woodstock, Illinois. The deep expertise in this specialised field, and reliable execution have been successfully applied to all primary inhaled dosage forms to accelerate drug development programmes and bring better treatments to patients worldwide.

Catalent combines its formulation expertise, manufacturing excellence and particle size reduction technologies to provide a broad range of solutions in the development of inhalation and nasal drug products.

Manufacturing and Formulation Solutions for Inhaled Dose Forms

	Catalent is the leading global provider of advanced drug delivery technologies and development solutions, providing worldwide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. The company has over 80 years’ experience serving the industry, and proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable product supply.

	Catalent’s solutions include analytical, pre-formulation and formulation, the recent addition of spray dry dispersion specialist Pharmatek, and biologics technologies and manufacture. Catalent now offers the most comprehensive toolkit of bioavailability enhancing technologies and the development of patient centric dose forms.

	Catalent serves thousands of innovators, both established and emerging, in over 80 markets, including 48 of the top 50 pharmaceutical and 41 of the top 50 biotech companies. Its team of over 1,400 talented scientists has supported over half of all new molecular entities approved by the FDA in the past 10 years, and from more than 30 global sites it supplies more than 70 billion units annually, to customers in over 80 countries.

	Whether an innovator is looking for a single, tailored solution, or multiple answers throughout a product’s lifecycle, Catalent can improve the total value of treatments, from discovery to market and beyond.