 Analytical services and chemical development Solvias is a world leader in contract research, development and manufacturing (CRO/CDMO). We work with customers across the entire pharmaceutical value chain – from research, chemical and analytical development to quality control of drug products. Our sophisticated technology and highly skilled employees contribute to our extensive experience in serving most of the top 100 pharmaceutical companies. The fact we have been doing this for almost 20 years means we are rooted firmly in the pharmaceutical industry and have an in-depth understanding of our customers’ requirements. What makes us different is that we offer not only analytical services but also chemical development. Full details |  ARCINOVA Arcinova is a Contract Research and Development Organisation (CRDO), providing the life sciences industry with a comprehensive range of services. At Arcinova, we are focused on Process Research, Development, Scale-Up and small scale manufacturing, including bioanalysis, DMPK, regulatory and consulting services, covering drug candidates in Development and launched to the Market. Recently, a request was submitted to Arcinova which required the manufacture of API in a vial to be used in Phase I single ascending dose (SAD) multiple ascending dose (MAD) Phase I trials. The timeline for completion was extremely tight and required manufacture and shipping of the drug product to be executed in 2 days, decreasing the standard duration by more than 2 weeks. Full details |
 BioConnection BioConnection is a Dutch contract drug product development and manufacturing organization for the development and GMP manufacture of injectable (bio)pharmaceutical products. Our capabilities are: Fill & Finish (vials, syringes, ampoules) for clinical trial and commercial purposes - freeze drying - lyo-cycle development and/or optimization - analytical development & validation - stability studies - Clinical Trial Material services (eg. labeling, packaging, storage & distribution) - Development and GMP drug product manufacture of complex formulations (e.g. microspheres, nanoparticles, liposomes). BioConnection is very well positioned to support (bio) pharmaceutical companies in bringing their inventions from the lab bench to the clinic and/or to the market. BioConnection offers services from its own facility and through our trusted partners.). Our own state-of-the-art GMP facility (Oss, the Netherlands) has an excellent manufacturing and regulatory track record (EMA and US-FDA). Full details |  cGMP plant for particle engineering Delivery problems related to poor solubility are low bioavailability, low penetration of the drug into the skin, large injection volume for intravenous (i.v.) administration and undesired side effects after i.v. injection when using traditional formulations. All these issue can be overtaken by use nanocrystal drugs. Full details |
 Challenges in Clinical Manufacturing Clinical manufacturing is an ever challenging business, especially in the early drug development phases where fast time-to-clinic is a crucial and demanding factor. While today’s manufacturing processes are becoming increasingly more sophisticated, ever more complex substances entering the process. Compounds are often very sensitive to the manufacturing environment and their primary packaging components. Full details |  Continuous Ozonolysis Reaction to Produce 4AA Asymchem successfully implemented an industrial scale continuous Ozonolysis process to manufacture 4-Acetoxy-2-Azetidinone (4AA). The adopted system is capable of processing 120kg of starting material (SM) per day to produce multi-ton quantities of product per year. The continuous process provides several advantages (greener, safer, higher throughput and less space required at the manufacturing site) over the batch process, making it very attractive for manufacturing. This poster describes the Ozonolysis process and the different advantages it has to speed up and secure material delivery. Full details |
 Extractables and leachables testing Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) headquartered in Stockholm, Sweden. We operate development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK, and the US and are continuing to grow and expand for our customers. We are focused on supporting pharmaceutical companies with our full service offering, taking products from early development through to commercial production. Our development & technology division operate from seven facilities and work in close collaboration with the expertise of dedicated development scientists. We offer clients a comprehensive range of services from pre-clinical medicinal chemistry, API process development, formulation development to production of clinical trial material of drug products. Full details |  Intertek Pharmaceutical Services At Intertek, we provide regulatory-driven, phase-appropriate, CMC laboratory and GMP analytical services. Our expertise ensures sufficient information for your filings through expert method development and validation, stability studies and GMP batch release testing for complex drug delivery, in particular inhalation, and formulation across both small and large molecules. To meet biopharmaceutical development milestones and comply with regulatory requirements safety assessment is paramount, as slight changes in the structure, physico-chemical properties, potency and impurity profile of a biologic can provoke an adverse immune response. In this poster we deploy Complement Dependent Cytotoxicity Assays (CDCC) and Antibody Dependent Cell Cytotoxicity (ADCC) potency assays to assess a monoclonal antibody biosimilar. Both assays are robust, reproducible and can be used to monitor changes in the biological functionality due to changes in the protein confirmation. Full details |
 Piramal's Integrated Offerings Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies and Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs, Antibody Drug Conjugation and are well versed in technologies such as Bio-catalysis. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. Our Development centers & Manufacturing sites have accreditation from regulatory bodies in US, Europe & Japan. Full details |  QBD STRATEGY FOR LC METHOD DEVELOPMENT As part of Quality by Design (QbD) principle, new tools allow pharmaceutical industry to develop more robust analytical methods from the earlier stages of drug development. With a QbD strategy, the method will be close to its optimum and more robust in comparison with “traditional†approach. This strategy has been implemented at Amatsigroup after several months of training and in- depth testing in order to use the software in an expert mode. One of our method development is presented in the poster. Full details |
 Quotient Clinical Quotient Clinical is a drug development services provider, focused on helping clients reduce the time and cost of bringing a drug to market. We deliver integrated capabilities including formulation development, GMP drug product manufacturing and clinical pharmacology services to biotech and pharmaceutical clients globally.  We employ over 600 staff and operate from state-of-the-art manufacturing and clinical facilities in the UK and USA. We can support our clients by working under FDA or MHRA guidelines and offer a full range of support services, from study set-up right through to data analysis and reporting Full details |  STA Pharmaceutical, a WuXi AppTec company STA Pharmaceutical, a WuXi AppTec company, is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms. STA began offering Flow Chemistry (Continuous Processing) services in 2013 and rapidly expanded due to our client’s need. Flow chemistry is a solution to some ubiquitous manufacturing challenges experienced with batch processing including process safety issues, presence of unstable intermediates, extreme reaction conditions requirements, the need for short residence time, and engineering issues such as poor heat or mass transfer in multiple phase reactions. Full details |
 Syngene International Limited Syngene International, one of India’s leading Contract Research Organizations, works with many of the world’s leading biopharmaceutical companies to develop novel therapeutic agents. Over the past 23 years since commencing operations, Syngene has developed a comprehensive suite of services in drug discovery, development and manufacturing. With a team of 3,500 highly skilled employees, we collaborate with a wide variety of 290+ customers ranging from start-up biotech through to leading multinational organizations including 8 of the top 10 global biopharmaceutical companies. Syngene’s state-of-the-art research and manufacturing infrastructure is spread across 1.3 million sq. ft space and includes Chemistry & Biology Laboratory Centers, a cGMP Kilo Lab, commercial manufacturing facility, Bio-manufacturing Facilities, HPAPI manufacturing plant, Animal Research Facilities, Formulation Development Center, Stability Center and clinical research facilities. Full details |  Tepnel Pharma Services Tepnel Pharma Services is an independent UK contract GMP quality control testing laboratory for the analytical testing of both developmental and market authorised pharmaceuticals. From our MHRA and FDA inspected facilities in Scotland we provide analytical support for UK, EU and global batch release activities, ICH Stability testing, compendial analysis in support of manufacturing and analytical methods development and validation. With a focus on tablets, capsules, parenteral, inhalation formulations and complex peptides, Tepnel draws on >30 years of experience servicing global pharmaceutical companies. Tepnel people are committed to providing laboratory services that deliver on the promise of affordability, adaptability and accountability with a strong outcome focussed culture and an emphasis on working collaboratively with our partners through a Vested Outsourcing approach we encourage you to let go of the things that you can’t change and focus on the things that you can. Full details |
 YOUR PARTNER IN PHARMACEUTICAL DEVELOPMENT Galenica is a Swedish privately owned pharmaceutical company with two business units, one for drug product contract development and one for development and launching of own branded pharmaceutical dermal products. In the contract development unit Galenica supports and guides our partners in their pharmaceutical development programs. We have expertise in pharmaceutical and analytical development as well as in production of Clinical Trial Material (CTM) for Phase I-III. Galenica also manufactures commercially niched products for the market and is authorized and audited by the Swedish Medical Product Agency. Galenica actively develops and launches own pharmaceutical products to the market, utilizing our state-of-the-art expertise in drug formulation, manufacturing and quality control. Our first product on the market, Ovixan(R)/Ovison(R), is an improved prescription-only mometasone cream formulation for the treatment of psoriasis and eczema. Full details |  Zhejiang Langhua Pharmaceutical Co., Ltd Owned by Ninhua Group Ltd., Zhe Jiang Langhua is an FDA approved APIs, intermediates manufacturer and customer preferred CDMO partner in China. With 30 years growth, Langhua has been the global leading company of quinolones, anti-virus, cardiovascular and anti-depressant APIs. Based on cGMP & ICH Guideline, Langhua established the robust quality system and passed FDA, WHO, EDQM, ANVISA and CFDA’s on-site inspections. 4 DMF were filed in USFDA. Langhua commits to be the customer-preferred APIs manufacturer and CDMO partner. Can provide One-stop Solution of product lifecycle management, including ROS development, process development & optimization, scale-up, registration & validation batch through to commercial batch production. Full details |
BOS 2017 poster submissions