2018

The Next Milestone in Cell and Gene Therapy

The field of cell and gene therapy is transforming the way patients who are diagnosed with cancers or genetic diseases can be treated. Today, the cost of producing these therapies still represents a major hurdle on the way to the commercialization. New technologies are needed that enable robust and cost-efficient manufacturing and yield replicable high-quality medicines. Although the therapeutic opportunities for patients are exciting, the stakes for patients and drug developers are high. We want to be your partner, add…

Capsule Delivery Solutions

Capsule Delivery Solutions, part of Lonza Pharma and Biotech, is the leader in capsule-based solutions and services, proudly offering Capsugel® products. With the largest production and supply chain footprint in the industry, Capsule Delivery Solutions provides the highest quality and deepest regulatory expertise to its 2,000 pharmaceutical customers, globally. For more information, email solutions@lonza.com, visit www.capsugel.com and follow us on Twitter, LinkedIn, and YouTube. Just fill out the form to view a full PDF and learn more.

Pfizer CentreOne Contract Manufacturing

Pfizer CentreOne is a global contract development and manufacturing organization (CDMO) embedded within Pfizer. We focus on custom API synthesis, sterile injectable fill–finish, and highly potent oral solid dose; and we are a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, we’ve manufactured complex compounds for our biopharmaceutical partners, guiding their drugs safely from development through commercialization. The Value of the Embedded-CDMO Model: Your molecule is manufactured in the same facilities that produce Pfizer’s…

Prometic Bioseparations Increases Manufacturing Capacity for GMP- Standard Chromatography Adsorbents

For over 25 years, Prometic Bioseparations Ltd (PBL) has produced chromatography adsorbents in batch sizes up to 280 L under cleanroom/good manufacturing practice (GMP) conditions at its Isle of Man (UK) manufacturing site. Following a sustained increase in demand for its chromatography products, PBL made the decision to expand its manufacturing operations to meet the projected future demand. During 2013, designs to expand the plant were developed. Between 2014 and 2017, a major investment focused on the expansion of PBL’s…

A World-Class Biopharmaceutical CDMO

Rentschler Biopharma SE — located in Laupheim, Germany — is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company’s clients include innovative biotech companies and major pharmaceutical companies around the world. Rentschler Biopharma has long-standing experience and proven excellence as a solution partner of choice. A top-notch quality management system, well-established operational excellence, and advanced technologies ensure product quality at each development and manufacturing step. Rentschler Biopharma is a family-owned company with over 850…

Biopharmaceutical Development and GMP Manufacturing: Clinical to Commercial Supply

Richter-Helm is a Hamburg, Germany–based contract manufacturing company with a proven 30-year track record and specialized in products derived from bacteria and yeasts. Count on us to flexibly provide a comprehensive range of services and customized solutions. Clients worldwide already have benefited from our commitment to good manufacturing practice (GMP) and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Our seasoned, 190-strong team supports you with process development, supply of products for clinical trials,…

The Microbial CMO – Process Development and Manufacturing of Biologics

Wacker Biotech is “The Microbial CMO” — partner of choice for process development and contract manufacturing of biopharmaceuticals (proteins, vaccines, and live microbial products) using microbial hosts. WACKER’s integrated service portfolio covers molecular biology, process/analytical development, and GMP manufacturing of biologics for clinical and commercial supply. WACKER operates three state-of-the-art GMP facilities located in Europe (Germany and Netherlands). Manufacturing lines with two 300-L and two 1,500-L stainless steel fermentation vessels, single-use fermentation lines, matching downstream processing scales and fill and…

Preventing the Risk of Contamination with a Robust System for Anaerobic Testing

Environmental monitoring, product quality control, and mycoplasma testing of biopharmaceuticals require anaerobic bacteria monitoring. If the proper environment is not created when performing microbial testing, bacteria will not grow, and a possible contamination could be missed. Any bacterial contamination of biopharmaceutical products can have major negative effects on manufacturing, production costs, and profit margins. A technology that relies on the evacuation and replacement of oxygen in a jar is valuable to the biopharmaceutical industry because it creates a quality-assured anaerobic…

Horizon’s Alternative CHO K1 GS Knockout Cell Line Drives Access to Cutting-Edge Biomanufacturing Cell Lines

Chinese hamster ovary (CHO) cells are the expression system of choice for the manufacturing of biotherapeutics. They have the capacity to express a range of proteins such as therapeutic enzymes or monoclonal antibodies at multiple gram per liter titers. As expression technologies have developed, obtaining such titers has been achieved mainly through improvements to media and feed. Similarly, the ability to identify high-productivity clones has been streamlined through the use of different selection systems, with metabolic selection being the preferred…

Purification Control Systems for Every Step of the Development Process

Early stage development of biological unit operations is critical to ensuring an efficient and robust commercially viable process. Often, the types of experiments required in early stage development are arduous tasks that require extensive testing of different critical process parameters, filters, and other essential production components. Such testing inherently produces massive amounts of data that must be carefully analyzed. To streamline the development process and optimize operational efficiency, PendoTECH has developed a full offering of control systems specifically designed for…