Biopharm product
development

Catalent Pharma Solutions provides the biotechnology industry with services for the development and production of biopharmaceutical and sterile products. For biopharmaceutical development, we are focused on developing and analytically evaluating large molecule pharmaceuticals. We have extensive experience in preformulation analysis and formulation development, and biomolecule structural characterization. We have the ability to perform clinical scale fill/finish manufacturing for liquid and lyophilized product.

Our experience includes extensive work with recombinant proteins, pegylated conjugates, monoclonal antibodies, peptides and oligonucleotides (siRNA, antisense, aptamers). Our scientific team has extensive biopharmaceutical product development experience and has a positive history of interactions with regulatory authorities on behalf of our customers.

We maintain state-of-the-art analytical instrumentation and our facilities are backed by a history of excellent GMP compliance.

Catalent’s biopharmaceutical product development experts have helped hundreds of companies make the difficult path through the biotechnology drug development cycle a faster and more successful endeavor.

Biomolecule Structural Characterization

Our analytical services group tests biopharmaceutical products to demonstrate that predetermined specifications are met and to provide evidence that the protein is safe, stable and maintains efficacy in the final product formulation. Products are physiochemically characterized by applying a variety of equipment and methods. Our testing services are designed to support pre-IND, Phase I, II, and III clinical trials and post BLA/NDA submissions. Our advanced equipment enables us to utilize a vast array of highly sensitive analytical techniques for biochemical characterization. We can characterize reference standards, determine impurity profiles, and identify degradation products.

• N-terminal sequencing
• Amino Acid Analysis (AAA)
• Extinction coefficient determination
• Carbohydrate analysis
• Peptide mapping
• Circular dichroism (thermal stability)
• High order structure

Preformulation

Catalent offers industry-leading capabilities in preformulation and formulation development.

We have years of experience designing preformulation studies to evaluate and select formulations, to development stability-indicating assay methods and to analyze the effects of manufacturing changes on the product. We have extensive capabilities in:

• Chromatographic system development
• Thermal analysis
• Physical and chemical accelerated stress testing
• Identification of conditions for optimal stability
• Selection of excipients and stabilizers
• Analytical method development and validation

Formulation Development/Dosage formulation design for liquid and lyophilized product

We recognize that successful development requires great science, a strong technological infrastructure and an understanding of what is necessary for your submission’s regulatory approval.

We test components for suitability in drug-product formulation and use stability indicting methods to evaluate their effect on the native structure and function of the biomolecules. Our rigorous approach incorporates product testing under diverse conditions and leads to a formulation that meets specifications and maximizes drug stability.

Components of a formulation development study includes:

• Method qualification and validation
• Container / closure selection
• Lyophilization cycle development
• Specification development
• Evaluation of degradation products

For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.