DAY ONE 1st November
NEWSLETTER Technology platforms mind the gap CordenPharma’s recent investments and global platform approach to CDMO development and commercialisation support pharma innovators to address their drug lifecycle gaps and reach patients faster.
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cross the spectrum of drug development, CDMO CordenPharma is aligning its facilities and technology platforms to mind the gaps pharma and biotech innovators often encounter as they work through development phases towards commercial markets and patients. Designed to promote the rapid scale-up of preclinical, clinical and commercial manufacturing capabilities, CordenPharma offers fresh thinking by experts in the forefront of their field and the latest science to accelerate development of today’s most advanced large and smallmolecule therapeutics.
With a fully-integrated supply model as an overarching focus, CordenPharma has made recent, significant investments under all five technology platforms (Highly Potent and Oncology – Lipids and Carbohydrates – Peptides – Injectables – Small Molecules) in its current Good Manufacturing Practice (cGMP) facility network across Europe and the USA to create the stable, streamlined outsourcing pharma needs to develop and commercialise critical medications, and reach global patients successfully. To read more go to: https://www. lskh.digital/article/technologyplatforms-mind-the-gap/
Farmabios, Novasep and PharmaZell are now Axplora c Following the merger of Novasep and PharmaZell Group in April 2022, the Farmabios, Novasep and PharmaZell brands are now being unified under a single name. c The merger brings together companies that share a track record of high quality, reliability and a complementary set of differentiated technologies. c The name Axplora reflects the ambition to be the partner of choice for complex APIs. It conveys the Axplora spirit and agility, underpinned by an innovative mindset which drives the company and its employees.
Farmabios, Novasep and PharmaZell officially announced today that they are coming together under the new brand Axplora. This announcement comes just 6 months after the closure of the merger of the Novasep and the PharmaZell Group. This marks the last step in the creation of Axplora, a leading Active Pharmaceutical Ingredients (API) manufacturing partner for pharmaceutical
and biotechnology companies worldwide, with a long track record of reliably developing and scaling up complex production processes and delivering medicines on time and at scale, to the highest industry standards. To read more go to: https://www. lskh.digital/news/farmabiosnovasep-and-pharmazell-are-nowaxplora/
Quotient Sciences completes major expansion of drug substance manufacturing facility Quotient Sciences, the drug development and manufacturing accelerator, has completed the expansion of its drug substance manufacturing facility in Alnwick, UK. The £6 million project results in a state-of-the-art drug substance manufacturing capability that can deliver integrated support for customers from candidate
selection through to early clinical development and beyond. The expansion delivers multipurpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 liters up to 150 liters and tactical deployment of batch or continuous flow chemistry technologies to optimize drug substance manufacturing
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processes. The facility has been designed adopting Industry 4.0 principles, with the inclusion of a predictive process control system (PharmaMV) improving the transfer from small-scale process research and development (PR&D) into manufacture of multi-kilogram quantities of drug substance for clinical use.
Mark Egerton CEO To read more go to: https:// www.lskh.digital/news/quotientsciences-completes-majorexpansion-of-drug-substancemanufacturing-facility/
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DAY ONE - NEWSLETTER
Lonza launches new capsule to deliver Acid-Sensitive Active Pharmaceutical Ingredients to the intestine
Catalent expands biologics analytical capabilities with new laboratories at Center of Excellence in Kansas City, Missouri
Lonza, a preferred partner to the pharmaceutical, biotech and nutraceutical markets, has launched an innovative new capsule solution for intestinal (enteric) drug delivery. The Capsugel® Enprotect™ capsule does not disintegrate during stomach transit and only releases its contents in the intestine. Capsugel® Enprotect™ capsules significantly simplify the drug product manufacturing process by mitigating the need for additional capsule coating or sealing. The Lonza Capsules & Health Ingredients Division has been a trusted manufacturing partner for leading global pharmaceutical and nutraceutical companies.
Catalent, the global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced a $12 million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City, Missouri. The project will see the
This expertise has enabled the development of innovative and reliable capsules with different release profiles, addressing changing patient needs while meeting regulatory requirements for multiple pharmaceutical and nutraceutical applications. This most recent capsule innovation has delivered a breakthrough non-coated capsule for enteric delivery that is suitable for all stages of development and commercial supply.
To read more go to: https://www. lskh.digital/news/lonza-launchesnew-capsule-to-deliver-acidsensitive-active-pharmaceuticalingredients-to-the-intestine/
addition of two new analytical development laboratories to support the growing demands of assay development for both traditional biologic and advanced biologic modality programs. To read more go to: https://www. lskh.digital/news/catalent-expandsbiologics-analytical-capabilitieswith-new-laboratories-at-center-ofexcellence-in-kansas-city-missouri/
Hovione expands drug product offering with a new manufacturing line dedicated to Continuous Tableting Hovione, the leader in spray drying and particle engineering, announced today that it has expanded its continuous manufacturing offering and services. A new state-of-theart continuous manufacturing facility is now coming online at
the Loures site in Portugal. In addition, to support Hovione’s commitment to providing access and services for continuous tableting, Hovione has further strengthened its capabilities
by establishing a highly experienced multi-disciplinary global team in continuous tableting and upgrading its labs with the tools needed to support the drug product lifecycle, thereby further guaranteeing competency and capacity from
research & development to commercial production. To read more go to: https://www. lskh.digital/news/hovione-expandsdrug-product-offering-with-a-newmanufacturing-line-dedicated-tocontinuous-tableting/
DAY ONE - NEWSLETTER
Tjoapack strengthens its Injectables offering with addition of pre-filled syringes assembly and packaging services
Terumo Pharmaceutical Solutions expands CDMO services outside Japan for global market
Global pharmaceutical contract packaging organisation (CPO), Tjoapack has invested in a new high-speed packaging line for pre-filled syringes and vials at its production facilities in both Europe and the US. The recently validated PFS line can pack pre-filled syringes of 1 to 5ml, with or without safety devices, and other customerspecific components can also be added. The move is in response to increasing customer demand for pre-filled syringes, which is a market expected to grow at a compound annual growth rate (CAGR) of 11.95% from 2022 to 2030. As part of several recent investments and expansions across the wider business, the
Terumo Pharmaceutical Solutions (TPS), a division of Terumo Corporation (TSE: 4543) and a leading manufacturer of injection, primary container, and infusion therapy devices, has today announced it will expand its contract development and manufacturing services for parenteral drugs to global customers. Terumo is a well-established integrated CDMO in Japan offering end-to-end services for more than 20 years, supporting customers with pre-filled syringe (PFS) design, molding, drug preparation, filling, assembly, and final packaging for challenging biotech drugs and small molecules. The company, which has three CDMO sites in Japan,
CPO said this funding will further enhance its integrated packaging offering. Marcelo Cruz, Vice-President of Business Development and Marketing, said: “The pressure to develop vaccines and treatments for Covid-19 has helped spur strong growth in the pre-filled syringe market. “As the market expands, this latest investment in our pre-filled syringe line is an important step to meeting the growing needs of our customers.
To read more go to: https:// www.lskh.digital/news/tjoapackstrengthens-its-injectables-offeringwith-addition-of-pre-filled-syringesassembly-and-packaging-services/ ingredients-to-the-intestine/
stated that the expansion would involve engaging on projects that cover the early development stage to large scale commercial production for global pharmaceutical customers including assembly of PFS with devices like autoinjectors, needle safety devices, and supporting customers for regulatory submissions globally Terumo is investing to expand the CDMO production facilities for pre-filled syringes at its wholly owned subsidiary Terumo Yamaguchi corporation Ltd. (Yamaguchi City). To read more go to: https:// www.lskh.digital/news/terumopharmaceutical-solutions-expandscdmo-services-outside-japan-forglobal-market/
Recipharm strengthens pre-filled syringe and cartridge offering with new investment Global contract development and manufacturing organisation (CDMO) Recipharm, has invested in a new high speed filling line for pre-filled syringes and cartridges at its facility in Wasserburg, Germany responding to increased customer demand in these high growth fill formats. As part of a programme
of recent investments and expansions across the wider business, this investment will further enhance Recipharm’s comprehensive manufacturing
offering for injectable products that require sterile filling. The leading sterile manufacturing facility specialises in more complex formats ranging from lyophilisation technology and aseptic filling into vials, syringes and cartridges. The investment will expand
Recipharm’s manufacturing footprint by adding a state-ofthe-art, high-speed filling line for pre-filled syringes and cartridges. To read more go to: https://www. lskh.digital/news/recipharmstrengthens-pre-filled-syringeand-cartridge-offering-with-newinvestment/
DAY ONE - NEWSLETTER The Knowledge Hub TV
Interviews
Azelis - Innovation through formulation NEW! LSKH TV at CPHI Frankfurt had the privilege of catching up with Matthias Hofmann, Managing Director - DACH & Innovation Director EMEA and Jatin Sharma Marketing Director at Azelis. We talked about INNOVATION THROUGH FORMULATION, their marketing strategies, innovation process and much more. To see the whole interview go to: https://www.youtube.com/watch?v=nHNB4cMjAzU
Gianmarco Negrisoli & Ken Drew, Flamma at @CPhI Global Pharma Events DAY ONE at CPHI! Find out what’s hot in the pharma and biotech industry. Here is the latest interview with Gianmarco Negrisoli and Kenneth Drew, from Flamma Group. To see the whole interview go to: https://www.youtube.com/watch?v=Fl-6xHGk5kY