Industry Yearbook 2014-2015

A Profile of Bosch Packaging Technology

Bosch Packaging Technology has been supplying the pharmaceutical industry with final fill solutions for over 30 years. During that time, Bosch has continued to focus on quality and industry-leading customer-focused solutions that provide the best return on investment over time. Filling Systems Bosch is the premier supplier of final fill–finish solutions to the pharmaceutical industry. As a single-source supplier with the industry’s widest portfolio of solutions, Bosch can supply the type and scale of equipment you require. We offer systems…

Expertise, Experience, and Excellence

Expertise Cobra Biologics is a rapidly expanding international contract manufacturing organization (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three good manufacturing practice (GMP)-approved facilities, each with expertise tailored to serving our customers across the world. We offer a broad range of integrated and stand-alone contract services, stretching from cell line and process development through to fill and finish for the supply of investigational medicinal products and commercial production. Experience For over 16 years, we have…

Commercial Prefilled Syringe Filling

The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.…

Cell Washing with the LOVO Cell Processing System

The ability to successfully produce cell-based products is partially dependent on the technologies and instruments available. Volume manipulation, supernatant or culture media exchange, and cell washing of the cell product can present a significant challenge, especially when cell recovery needs to be maximized without compromising viability. LOVO is a multiuse, bench-top instrument that pumps a cell solution through a spinning membrane filtration device to allow for rapid fluid management and fast, efficient cell processing. At its core, LOVO leverages Fresenius…

Focused Process Development for Reliable Biomanufacturing: Experience and Innovation in Cell Culture

Fujifilm Diosynth Biotechnologies (FDB) leverages over 15 years of experience in bioprocess development and manufacturing to successfully deliver robust process designs to its clients. FDB has executed a series of innovation programs to enable rapid development of cell culture processes, including the coming launch of a new Chinese hamster ovary (CHO) expression system. This application note describes how outputs from media screening and upstream process development innovation programs were applied to provide significant productivity and process robustness improvements to an…

Production of T Cells for Adoptive Cellular Immunotherapy: Using the Xuri™ Cell Expansion System W5

The Xuri cell expansion systems (Xuri W25 and W5) provide a functionally closed, single-use bioreactor that requires fewer operator intervention steps, reduces the risk of contamination, and controls the cellular environment to maximize cell yield. Data presented here highlight that at a cellular level, results from different bioreactors may appear similar, but differences can exist at the receptor expression level. Expansion of T Cells Peripheral blood mononuclear cells (PBMCs) were expanded in static culture. On Day 5, 2-L Xuri Cellbag…

Bio on demand™

NNE Pharmaplan has developed a new facility concept called Bio on demand™, which enables facilities to be established in one to two years. The result is a flexible facility that is fully operational, locally compliant, and contains functioning quality systems. Bio on demand™ involves a high degree of single-use technology to ensure cost-effective production and fast establishment. Facilities based on our Bio on demand™ concept can be delivered globally, but they are primarily intended for growth markets where time-to-market is…

Development By Design

Unlike typical pharmaceuticals, cell therapies rely heavily on the manufacturing process for product attributes. As more products move out of the clinic and toward commercialization, the manufacturers of cell therapies are realizing that commercialization is unlikely to be successful without an effective methodology for manufacturing development. At PCT, we recognize that a successful commercial manufacturing vision includes the ability to provide consistently high product quality at a reasonable cost of goods that meets demand over the commercial life of a…

Quality, Performance, and Integrity Make the Difference

Pyramid Laboratories, Inc. is a contract aseptic manufacturing and analytical services organization for sterile injectable drugs. Pyramid provides expertise in formulation and process development, aseptic filling for vials and syringes, and lyophilization applications. Pyramid has established a reputation of exceptional performance, integrity, and quality. Technical Services Pyramid offers a wide array of services for all phases of drug development and production including formulation and process development lyophilized product formulation and cycle development clinical and commercial vial and syringe fill–finish clinical…

High-Performance Biopharmaceuticals Manufacturing

Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with a proven track record for over 40 years. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many…