Founded in 2000 in Grenoble, France, Protein’eXpert is an expanding contract research organization devoted to recombinant protein engineering and production. Our 50-member staff offers custom-designed services focusing on the discovery, optimization, and production of valuable target or therapeutic proteins. Since 2004, Protein’eXpert has extended its offering to the biomanufacturing of therapeutic protein and recombinant vaccines for early clinical trials through its integrated subsidiary PX’Pharma. PX’Pharma provides dedicated contract services for process development and scale-up optimization as well as preclinical and…
2008
Developing Scalable, Robust Processes That Result in Stable, Active Products
KBI Biopharma is a leading contract development organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners, including global pharmaceutical and biotechnology companies and organizations in biodefense. Our clients benefit from faster time to market and lower cost of manufactured goods. Ongoing Innovation We are continually working on new technologies and new partnership opportunities to enhance biomanufacturing. Our expertise in biophysical and biochemical protein characterization makes us highly successful in delivering optimal…
From Cell Line Optimization to Aseptic Filling
The biopharmaceutical industry is faced with a challenging task: planning, developing, manufacturing, and bringing to market a highly specialized and complex biopharmaceutical product. Competitive pressures, cost, and — above all — time to market are of key concern. The wide range of implementation options, from in-house resources to outsourcing companies of various calibers and capabilities, adds yet another layer of complexity to the decision-making process. Our objective is to offer our customers a full-service alternative to the development and manufacturing…
Optimization of a PEGylation Reaction Using Design of Experiments (DOE)
The covalent attachment of polyethylene glycol (PEG) to a therapeutic protein is frequently used to increase the half-life of that protein in patients while reducing their immunogenic response. The PEGylation reaction can be optimized to maximize the desired product (average moles of PEG per mole of protein) molecules while limiting undesired byproducts (under- and over-PEGylated species). In the example discussed here, the desired molecule was mono-PEGylated, yet the preoptimized reaction yielded multi-PEGylated species visible by SDS-PAGE. The goal of our…
A Leader in Filling Technology Services
HCM is a leader in upscale process development and aseptic filling of liquid parenterals in syringes, vials and custom containers. HCM offers clients–from newly-established firms to large-scale commercial enterprises–high quality services and innovative technologies. Quality Services Quality Services Foremost among the services HCM offers are upscale process development and aseptic filling of syringes, vials, and custom containers. In addition to traditional fill and finish, HCM offers online vacuum filling and stoppering as well as lyophilization. HCM offers customers a Stability…
Designing, Developing, and Delivering Our Clients’ Biopharmaceuticals
Eden Biodesign is one of Europe’s leading contract biomanufacturers. We are an expert provider of consultancy, biopharmaceutical process development, and CGMP manufacturing services. Our rarely found blend of experience and expertise, gained from providing our services to more than 100 clients worldwide, ensures that the clinical medicines we develop are regulatory compliant and optimally positioned for further clinical and commercial development. Our state-of-the-art facility is licensed to produce clinical products, which we believe is best in class for its scale…
Biopharmaceutical Product Development
Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides and other biotechnology-derived active materials and small molecules — helps to maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and Drug Product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists and pharmaceutical scientists provide the…
CMC Continues to Grow
With expansion of production capacity, range of services, and customer base, CMC continues to grow. Earlier this year, CMC acquired the former ICOS Biologics development and manufacturing facility in Seattle, WA, from Eli Lilly. Now known as CMC ICOS Biologics, this facility focuses primarily on mammalian production, and during 2008 it is being upgraded to enable production of in-market biopharmaceuticals as well as late-stage clinical trial material. Dr. Gustavo Mahler, previously with Bayer Healthcare, has been appointed president of CMC…
Boehringer Ingelheim: From Mind to Market Our Services in Biopharmaceutical Contract Development and Manufacturing
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 employees. Since its foundation in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing innovative products of high therapeutic value for human and veterinary medicine. Our therapeutic areas are respiratory, cardiovascular, central nervous system, urology, virology, rheumatology, metabolism, immunology, and oncology. Boehringer ingelheim is one of the…
Providing Process Solutions for the Biopharmaceutical Industry Worldwide
Figure 1. Integrating production processes within a complete facility does not always lead to a costly execution and long time to market for end users. This is what a specialist company such as Boccard can offer thanks to its expertise in process design and construction of pharmaceutical GMP systems, and thanks to a different project implementation strategy that focuses on the client’s core business, production needs, and operating methodologies. Case Study: Alpha Biologics Facility Project in Malaysia Present in 20…