CPhI report predicts new finished product manufacturing hub in the Middle East

May 31, 2018

Forgotten markets of Africa and Arabia to see increased growth fuelled by international & domestic partnerships and imported APIs A new report by CPhI forecasts sizable changes ahead for the pharma markets in the Middle East and Africa over the next few years. It highlights recent regulatory changes, coupled with increased geopolitical stability and rising generics consumption as key drivers in transforming the prospects of pharma manufacturers in the region. The CPhI Middle East and Africa report – released ahead of the inaugural edition of CPhI MEA (03-05 September 2018, Abu Dhabi) – has identified significant opportunities for a region ...

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Almac Group Appoints David Taylor as Head of Manufacturing Operations

May 1, 2018

David Taylor joined the Almac Group in November 2017 as Head of Manufacturing, Almac Sciences.  He is tasked with the overall accountability for small molecule API and peptide manufacturing in Craigavon, and delivering on Almac’ Sciences’ supply chain operations at the Northern Ireland site.  David has worked in the pharmaceutical and fine chemical industries for over twenty-two years, and brings with him a strong background in both the technical and manufacturing disciplines, allowing him to lead multidisciplinary teams to deliver streamlined operational outcomes. In an industry with significant emphasis on safety, quality and regulatory compliance, David has the skill set ...

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Phoenix Molecular Designs Announces Manufacturing Collaboration with WuXi STA to advance PMD-026 toward IND

Apr 18, 2018

MD-026 is the first RSK inhibitor to demonstrate potential disease-modifying properties in triple-negative breast cancer (TNBC)   Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, announced that it has entered into a collaboration with STA Pharmaceutical Co., Ltd (STA), a WuXi AppTec group company, to manufacture the PMD-026 needed for IND-enabling toxicology studies and a Phase I study in women.   Under the terms of the collaboration agreement, STA will become a new manufacturing partner for PhoenixMD for their platform of kinase inhibitor drug candidates to treat a wide range of unmet ...

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ISPE Quality Manufacturing Conference Brings Together Regulators and Pharma Industry Experts

Apr 10, 2018

The International Society for Pharmaceutical Engineering (ISPE) announced its 2018 Quality Manufacturing Conference, taking place 4–6 June in Arlington, Virginia USA. Broad regulatory involvement throughout this signature conference makes it the ideal setting for pharmaceutical professionals to gain a clear understanding of current regulatory perspectives on quality manufacturing topics—including quality agreements, API starting materials, human error prevention, contamination control, and patient-centric specification. “Our program committee is very passionate about quality initiatives and making sure we’re doing the right things to manufacture high-quality drugs,” said Timothy Watson, PhD, Program Chair and Senior Director, GCMC Advisory Office, Pfizer, Inc. “We are working ...

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SYGNIS AG Installs Scalable Production Capability for Lightning-Link Antibody Conjugation Technology

Jan 16, 2018

SYGNIS AG (Frankfurt: LIO1; ISIN: DE000A1RFM03; Prime Standard), the Group which includes Expedeon Holdings, Innova Biosciences, and C.B.S. Scientific Company, today announced it has extended the manufacturing capability for its Lightning-Link® technology, currently marketed under the Innova Biosciences brand, to support scalability and bulk production of antibodies.   Lightning-Link is an innovative technology that enables direct labeling of antibodies or proteins in as little as 20 minutes, for use in R&D applications, drug discovery and the development of diagnostic kits. Lightning-Link kits are the world’s fastest, easiest to use and most efficient method of labeling antibodies or proteins, requiring only ...

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