July 29, 2021
ISPE SmartBrief
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Top story
The US National Institute of Standards and Technology, the National Institute for Innovation in Manufacturing Biopharmaceuticals and US Pharmacopeia will collaborate on the development of measurement methods and reference materials for adeno-associated viruses for use as vectors in gene and cell therapies.
Full Story: European Pharmaceutical Review (UK) (7/28) 
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How Digital CMC Enables Rapid Tech Transfer
According to McKinsey & Company, a typical tech transfer project takes 24 to 30 months and can cost up to $389M in personnel costs alone. Learn how companies are reducing tech transfer times from months to weeks and dramatically lower costs while reducing risk by leveraging a Digital CMC platform. Read Now
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Process development and manufacturing
Half the respondents to a Verdict poll said the adoption of robotics in drug development, manufacturing and anti-counterfeiting will not peak for at least five years, 13% said it will peak in three to five years, and 11% said it would peak in one to three years. The Robotic Industries Association said the number of robots ordered by life sciences companies in North America was 69% higher last year than in 2019, and most are used for dispensing, sorting, assembling, light machine-tending and packaging.
Full Story: Pharmaceutical Technology (7/28) 
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Small businesses often don't own their facilities or do their own manufacturing -- factors that complicate their path to net-zero climate impact. Such resources as the SME Climate Hub and Moody's ESG Score Predictor offer ways small companies can measure and reduce their environmental footprints.
Full Story: GreenBiz (7/26) 
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Better Data Means Less CAPAs
Digitized data means increased visibility and more powerful analytics. Attend our webinar and learn how artificial intelligence can save you time, money, and stress through streamlined data, predictive analytics, and CAPA reduction. Register for the webinar.
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Facilities and equipment
Demand for novel therapies is driving a shift in biopharmaceutical development and manufacturing from a blockbuster model to an emphasis on quality and value, says Mike Barrett, vice president of project delivery services at engineering firm CRB. Office, laboratory and research spaces are becoming more flexible so they can be changed without major investment, and technology is being selected based on priorities such as environmental sustainability or speed to market, Barrett says.
Full Story: Genetic Engineering & Biotechnology News (7/28) 
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Kriya Therapeutics says its good manufacturing practice-compliant facility in North Carolina will begin producing gene therapies later this year. The company recently raised $100 million in a Series B round, which CEO Shankar Ramaswamy says "will be used to further develop our core technology platforms, expand our pipeline and advance our current programs in metabolic disease, ophthalmology and oncology."
Full Story: BioProcess International (7/26) 
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Recent industrial pump innovations include advanced water management systems, high-tech sensors, improved seals and troubleshooting tools. A project to install improved seals at a food processing plant and a demand-driven supply system for a drinking water network are among six case studies that highlight opportunities for saving energy and money.
Full Story: Plant Services online (7/21) 
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Danaher Corp. subsidiaries Cytiva and Pall are investing $1.5 billion at 13 manufacturing sites to accelerate expansion plans already underway. Cytiva expects to double cell culture media capacity at its Logan, Utah, site, and Pall will expand single-use manufacturing operations in China and open a new facility in Cardiff, Wales, to manufacture equipment for single-use bioprocessing, including bags, flow kits and tubing assemblies.
Full Story: BioPharmaReporter (7/27) 
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Featured Content
Sponsored content from ICQ Consultants
5 ways to meet rapidly growing demandMany biopharma companies are facing a sharp increase in demand that can be challenging to meet amid supply chain disruptions and normal growing pains. Maintaining quality and consistency is critical while scaling up and expanding operations.

How do you plan to meet growing product demand? Consider these 5 components any biopharma company can use to increase quantity without sacrificing quality.

    Information systems
    Biopharmaceutical companies' data integrity management programs are increasingly complex, costly and subject to human error as automated equipment generates more data points that must be verified, and off-the-shelf products may be an affordable way to manage risks, writes Peter Cusworth, account manager for industrial automation company Yokogawa. The cost of meeting data integrity requirements may appear to outweigh investments in newer equipment and systems, but "this attitude has been shown to have far-reaching complications, hitting share prices and big-name reputations," Cusworth warns.
    Full Story: European Pharmaceutical Manufacturer (7/28) 
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    Supply chain management
    South Korea's reliance on imported active pharmaceutical ingredients has increased significantly since 2017, according to the Korea International Trade Association. In 2019, 36.7% of Korea's API supply was from China, 13% was from Japan and 10.2% was from India, and the association says Korea should reorganize its API supply chain.
    Full Story: Korea Biomedical Review (7/27) 
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    Quality and regulatory issues
    India's Department of Pharmaceuticals extended the application deadline to Aug. 31 for manufacturing key starting materials, drug intermediates, active pharmaceutical ingredients or medical devices under the production linked incentive scheme. The department also invited applications to produce ofloxacin under the PLI scheme.
    Full Story: PharmaBiz (India) (7/28) 
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    ISPE update
    Awareness of the pharmaceutical industry has increased significantly in the last 15 months due to the global pandemic. Vaccine manufacturing is now in the spotlight more than ever before. The issues of production output, supply chain shortages, and cold chain distribution have been discussed in mainstream media and are now commonly understood. However, when COVID-19 took hold at the start of 2020, most countries were not prepared or knew how to respond. With a focus on protecting their citizens, strengthening their economies and returning life back to normal, governments were searching for solutions to a hugely complex global problem at breakneck speed. Full Story: iSpeak
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    The past year has been unprecedented for the manner in which the world's population has adapted to living with the changes brought about by COVID. The life sciences sector has always been to the fore at unleashing scientific innovation to make life better for humanity, and that creativity went into overdrive as the industry pivoted to meet those challenges. Full Story: iSpeak
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