August 2011

Plant Engineering and Construction by M+W Group

A subsidiary of the M + W Group, M+W Process Industries GmbH is a leading global engineering and construction company offering complete process and facilities solutions from design to construction. M+W Process Industries has the experience and the know-how for design and execution of all types of biotechnology and pharmaceutical production systems. The portfolio includes research plants as well as industrial facilities, monoproduct and multiproduct plants, variable single-use systems, and large-volume stainless-steel production units. The needs and requirements of our…

Vivalis CMO Services

Since 2006, Vivalis has operated and maintained a GMP manufacturing facility for the production of monoclonal antibodies, recombinant proteins, and viral-based products. Founded in 1999, Vivalis has developed a series of innovative technologies to address the needs of biopharmaceutical development. These include novel cell substrates, such as our avian EB66® cell line, which has seen wide application in areas from vaccine manufacturing to monoclonal antibody development. Our CMO services not only include those for clients using the EB66® cell line,…

Althea Technologies, Inc.

          Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and cGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach, or just the parts you need. While realizing all of the tangible benefits of consolidating your development and manufacturing steps, you’ll…

Cryogenic Storage of Human Hematopoietic Progenitor Cells

Successful cryopreservation of hematopoietic progenitor cells (HPC) depends on a number of factors: biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation, and transfer of hematopoietic progenitor stem cells (HPCs). These bags are made from a unique polyolefin film that offers excellent durability while remaining flexible when stored at ultralow temperatures (−196°C). Their proprietary membrane port design offers thinner walls for increased flexibility, and an industry-standard label…

Intelligent Tools to Facilitate Bioprocess Development

Continously new bioprocesses are evolving, and bioprocessors are searching for the easiest way to process samples in R&D. Currently, a huge trend towards disposable production systems is notable. For these purposes plastic bags, stirred-tank reactors, and storage tanks established on the market. Unfortunately, these reactor types are not suitable to perform sophisticated bioprocess development. In bioprocess R&D, throughputs of 50 to 1,000 fermentations are needed. Therefore, m2p-labs developed intelligent new tools at microscale to fulfill the needs in bioprocess development.…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with more than 20 years of experience in microbial systems. We offer proprietary technologies (ESETEC®, DENSETEC®) that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust and highly efficient processes and GMP-compliant manufacturing for clinical trials and commercial supply. We opened recently a new process-development unit to optimize the entire process-development chain, from gene to purified protein. Asecond extension at the Jena…

Turn-Key Bioreactor Solutions

          In order to reduce scale-up costs and facility capital expenses, biotechnology companies are adopting single-use systems. To fully enable the single-use paradigm, automation software, hardware, and single-use sensors must be optimized; moreover, both validation documents and materials certifications must be readily available for cGMP implementations. Finesse provides turn-key, configure-to-order measurement and automation solutions for many single-use bioreactor types: “stirred-tank,” “paddle,” or “rocker” systems. The Finesse turn-key system is optimized for each bioreactor type to maximize…

Rapid Cell Line Development with Integrated Protein Analysis

          The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell…

An Update on the Advantages of Fibra-Cel® Disks for Cell Culture

          With a renewed acceptance of perfusion processesin cell in culture, both in the laboratory and for production applications (1), New Brunswick packed-bed bioreactors using Fibra-Cel® disks are seeing an upsurge in interest. This article examines Fibra-Cel technology and its many advantages, from increased yields of secreted proteins to labor savings in applications ranging from rabies vaccine production to production of the first licensed gene therapy drug.   What Is Fibra-Cel?   Fibra-Cel from New Brunswick…

A Faster, Flexible Alternative to Conventional Outsourcing for Biologics

          For many developers of new biologics, outsourcing clinical or commercial manufacturing with a contract manufacturing organization (CMO) makes good sense. Dozens of capable CMOs offer ready capacity to companies who can’t afford the time, capital or risk involved in building their own biomanufacturing capacity. Of course, the convenience of instant access to a CMO’s infrastructure comes at a steep price: Many CMOs use proprietary cell lines, media, and other technology that will limit a drug…