Fill/Finish

New Approaches to Fill and Finish: A BPI Theater Roundtable at Interphex 2015

On Wednesday, 22 April 2015, Susan Dexter (principal consultant at Latham BioPharm Group) chaired a midday roundtable titled, “Fill and Finish Manufacturing Strategies: Better or Just New?” She brought together three industry experts to provide mixed perspectives: Joseph Figlio (senior project officer for the manufacturing facilities and engineering division of the Biomedical Advanced Research and Development Authority, BARDA, in the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response) Victor Lee (vice president…

Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow–Fill–Seal Plastic Vials

PREPRINT October 2015 issue Blow–fill–seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1–3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the pharmaceutical industry for decades, primarily in the respiratory and topical ophthalmic markets. Such product formulations range from simple solutions to emulsions with drug substances from classical small molecules to large complex proteins such as biologics. The company also has optimized BFS processes and its Advasept plastic container system for…

Secondary Packaging: Creating Value with Product Lifecycle Management

with Daniela Guttmann and Susanne Hall Increasing regulatory requirements combined with the market pressure to develop patient-friendly drug delivery systems make product lifecycle management (PLM) a decisive field for today’s pharmaceutical and biotechnology companies. Their strategic service providers also are affected by those conditions. For example, as an internationally operating contract development and manufacturing organization (CDMO), Vetter reports an increasing number of life-cycle management projects with its customers in the past years. Learn more in this white paper from Vetter.…

Maximizing PMBC Recovery and Viability: A Method to Optimize and Streamline Peripheral Blood Mononuclear Cell Isolation, Cryopreservation, and Thawing

The quality of peripheral blood mononuclear cells (PBMCs) isolated from whole blood has a significant impact on their subsequent analysis. Maximizing recovery, viability, and functionality of isolated PBMCs is essential to the reliability and consistency of downstream applications, particularly within cell therapy manufacturing. The standard method for purification of PBMCs is density-gradient centrifugation. It requires precise layering of whole blood over a density medium (e.g., Ficoll polysaccharide reagent from GE Healthcare), with careful pipetting of the floating cell layer after…

Automation of a Single-Use Final Bulk Filtration Step: Enhancing Operational Flexibility and Facilitating Compliant, Right–First-Time Manufacturing

Single-use technologies have been implemented in biomanufacturing facilities all over the world. Inherently more flexible than stainless steel equipment, single-use technology allows for more rapid technology transfer by minimizing the time it takes to design, purchase, and qualify new capital assets. Rapid turnover between batches is facilitated with no need for protracted clean-in-place (CIP) and steam-in-place (SIP) regimes; the risk of product cross contaminations is reduced because single-use fluid-contact surfaces are never previously exposed to a biopharmaceutical product stream. For…

The Importance of the Concentration-Temperature-Viscosity Relationship for the Development of Biologics

JIM DELILLO (WWW.FREEIMAGES.COM) Patient preference and a competitive landscape in the parenteral market have fueled the need for convenient delivery systems and a desire for less‑frequent dosing injections. Monoclonal antibodies (MAbs) often have high dose requirements, so they must be formulated at very high concentrations (1). At low concentrations, an antibody solution’s viscosity increases moderately as a function of protein concentration. But at high concentrations (>100 mg/ mL, depending on the molecule), viscosity increases exponentially (2, 3). Thus, a specification…

Simulating Seal Life with Finite-Element Analysis

Finite-element modeling is an attractive alternative to physical testing for predicting seal life, particularly when aging poses major concerns and seal replacement is expensive. For years, seal manufacturers and users alike have searched for a reliable method for predicting how long seals will last in service. Past methods for evaluating an elastomer’s potential as a static or dynamic seal use American Society for Testing and Materials (ASTM) or other standard immersion tests. These tests involve submerging a material in a…

Evaluating Freeze–Thaw Processes in Biopharmaceutical Development – Small-Scale Study Designs

Regulations mandate that biopharmaceutical product quality be controlled throughout manufacturing, storage, transportation, and delivery to patients (1). Operations often include freezing and thawing of a bulk drug substance, dilution of that purified substance to a target concentration, filtration, filling into a selected container–closure system, additional processing (e.g., lyophilization), inspection, packaging, storage, transport, and delivery (2). Freezing is a common processing step used to maintain stability and quality of a drug substance during development and production of biopharmaceutical products. It is…

Sterilization Effects on Elastomer Characteristics and Functionality in Parenteral Delivery Systems

To drive efficiencies in producing parenteral drug products, manufacturers are using containers and closure components that are received sterile and ready to be introduced into filling lines. The effects of sterilization on the properties of ready-to-use (RU) components must be assessed to ensure proper processing techniques and suitability over the components’ intended shelf lives. Sterile-drug manufacturers must determine the best sterilization method for components based on their respective drug products and processes. Critical areas of risk include potential changes related…

A Critical Mission: Clinical Trial Material Storage and Distribution

As if manufacturing of investigational medicinal products (IMPs) weren’t challenging enough already, the appropriate storage and distribution of sensitive biological products can be an adventurous journey itself — especially if not carefully planned and managed. No one solution fits all situations. Many things must be evaluated during planning stages. For example, what is more important: time to delivery or quality of transport and product integrity until drug can be administered to a patient? It is important to understand key storage…