Althea is a fully integrated contract development and manufacturing organization providing clinical and commercial drug product services. Althea offers cGMP drug product filling in both vials and syringes and production of microbial-derived recombinant proteins and plasmid DNA. Comprehensive development services are available, including upstream and downstream process development, analytical development, lyophilization, complex formulation, product release, and ICH-compliant stability testing. Althea offers a proprietary formulation technology platform, Crystalomics®, and Corynex® protein expression technology. Login to read the full PDF of the…

Avid Bioservices is a contract development and manufacturing organization (CDMO) specializing in mammalian cell culture process development and cGMP production of clinical and commercial-scale monoclonal antibodies, recombinant proteins, and enzymes. Committed to the success of our clients, our team constantly strives to build partnerships that extend well beyond the delivery of your product. By combining our knowledge and experience with a flexible and efficient approach, we can meet your specific project requirements. Established CDMO with a Broad Range of Capabilities…

The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing annually at >15%, making it the largest and consistently fastest growing segment of the healthcare industry with annual sales in excess of US$200 billion. Contract manufacturing organizations (CMOs) are expanding capacity by building new cost-efficient facilities, reflecting market demand. Many product sponsors are outsourcing, some even increasing…

Our state-of-the-art biologics manufacturing facility (which uses single-use systems) is expanding to add 22,000 ft2 of space and with that, the flexibility and scale to support your growth. The expansion adds a new 2 × 2,000-L single-use bioreactor system to support late-phase clinical and commercial-scale production of up to 4,000-L batches, as well as expansion of analytical and process development laboratories. Catalent offers a broad range of integrated process development and analytical services to solve your most difficult development and biologics…

The quality of pharmaceutical products is the top priority for both biopharmaceutical companies and regulators. To ensure consistently high product quality and improve the efficiency of manufacturing and regulation, the US FDA introduced quality by design (QbD) to the pharmaceutical industry in its 2002 Pharmaceutical CGMP initiative, Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (1). Since the introduction of QbD, the FDA has taken multiple measures to promote industry-wide implementation, but the industry’s response to QbD has been…

Single-use technology has been transforming the modern biomanufacturing workflow. You can now find single-use bags at every stage of bioprocessing: bioreactor and mixing systems, harvest and collection, purification, liquid and powder storage, and transportation. The Strength of Simplicity: One Film for Bioprocessing At GE, we’re introducing one film for our entire portfolio of single-use systems. It’s named Fortem after the Latin word for strong — and aptly so because it is strong in many ways. It was born of customer collaboration, supplier…

MabPlex provides world-class solutions to biopharmaceutical clients around the world. Our company is based on the quality by design (QbD) principle, from site construction to manufacturing and delivery of our clients’ biologic drugs. With an expert team adept in both chemistry and biology, MabPlex provides global contract development and manufacturing organization (CDMO) services in biopharmaceuticals. Capabilities span the scope from monoclonal antibodies (MAbs) and fusion proteins to the most complicated antibody–drug conjugates (ADCs). Our 275,000-ft² manufacturing space offers flexibility and…

Rentschler Biotechnologie GmbH, located in Laupheim, Germany, is a leading biopharmaceutical contract development and manufacturing organization (CDMO) for bioprocess development and manufacturing of biopharmaceuticals and an experienced specialist in mammalian cell culture. The company’s clients include innovative biotech companies and major pharmaceutical companies around the world. Many years of experience and excellence in finding solutions as well as certified quality management and advanced technologies ensure Rentschler’s high-quality standards. Rentschler Biotechnologie is a family-owned company employing approximately 700 people. Full-Service Provider…

Richter-Helm is a Hamburg, Germany–based contract development and manufacturing company with a proven 25-year track record, 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, 160-strong team supports you with process development, supply of products for clinical…

Wacker Biotech is “The Microbial CMO” — the partner of choice for contract manufacturing of therapeutic proteins using microbial hosts. Our service portfolio covers molecular biology, process and analytical development, and the GMP production of biologics for clinical trials and commercial supply. Founded in 1999 as a spin-off from the Hans-Knöll Institute in Jena, we are a 100% subsidiary of Wacker Chemie AG since 2005. The sites in Jena and Halle provide a complete range of services for the development…