DAY TWO 2nd November
NEWSLETTER A Continuous Flow Process revolution… through innovation
S
K pharmteco provides expertise in continuous processing and is a recognised worldleader in the development and manufacturing of custom cGMP Intermediates and APIs using continuous processes. In contrast to the traditional batch mode of production, manufacturing by Continuous Flow Process is fluid, offering a greener more environmentallyfriendly alternative. Continuous Processing can lead to safer and more economical and scalable
Live from CPHI Winners of Pharma Awards 2022 declared
production, reducing costs, waste and cycle time to improve quality and yield. However, manufacturing at small scale via continuous flow processing is usually hindered by the excessive lead time required to build dedicated and expensive small-scale units. AMPAC Fine Chemicals (AFC), an SK pharmteco company, has revolutionised continuous process manufacturing development through the use of a unique inhouse modular approach. These modules can produce multi-kilograms of material per day, which can be used for the initial scale-up production of clinical phase programs, as well as commercial drug products under cGMP.
CPHI Frankfurt announces the winners of the prestigious 2022 CPHI Pharma Awards, recognising outstanding achievements from the global pharma industry, across 10 specialist categories. Manni Kantipudi, CEO of Aragen was chosen by the judges as the clear winner of CEO of the Year, one of the most coveted prizes, for delivering outstanding performance with sustained growth and robust strategies. The company has undergone a number of impressive facility improvements, investment rounds and double-digit growth. Moderna’s development of its SPIKEVAX mRNA-based vaccine received the special award for Innovation in Response to COVID-19 category. The messenger RNA (mRNA) technology used in Moderna’s COVID-19 vaccine is based on more than a decade of research
and, having received emergency authorization in 70 countries, more than 807 million doses of the vaccine were shipped globally in 2021. In the API Development category, the Tokuyama Corporation was chosen for its novel synthesis of sodium dependent glucose co-transporters (SGLT2), used in the treatment of diabetes. Previous synthetic methods suffer from need for cryogenic conditions (-78oC), which significantly restricted the supply of this important class of drugs. The Tokuyama Corporation addressed this challenge by developing a new synthetic method which can be undertaken under very mild conditions (40oC). To read more go to: https://www. lskh.digital/news/live-from-cphiwinners-of-pharma-awards-2022declared/
To read more go to: https://www. lskh.digital/article/a-continuousflow-process-revolutionthroughinnovation/
CKH.DIGITAL
c
LSKH.DIGITAL
DAY TWO - NEWSLETTER
Piramal Pharma Solutions announces winner of its September 2022 Award for Excellence in Patient Centricity
P
iramal Pharma Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), announced that the company’s site in Pithampur, Madhya Pradesh, India, has been selected as the winner of the most recent PPS Award for Excellence in Patient Centricity. The Pithampur Patient
Awareness Council (PAC) was recognized for the program entitled “Imbibing Patient Centricity in All Strata, Internally & Externally.” This award, which is given out twice per year, goes to the Patient Awareness Council (PAC) at a PPS site in recognition of a specific program they initiated related to Patient Centricity. A core
ideology of the company, Patient Centricity is built upon the principal that understanding the needs of patients and building an organization that is dedicated to addressing those needs is foundational to the company. As part of the Patient Centricity onboarding initiative, employees at all fourteen of the company’s sites around the world received dedicated
training on how to embrace the concept and make the program a reality. Patient Awareness Councils were formed at each site for the purpose of driving the idea forward at a local level. To read more go to: https://www. lskh.digital/news/piramal-pharmasolutions-announces-winner-ofits-september-2022-award-forexcellence-in-patient-centricity/
Leading resin manufacturer Purolite extends strategic partnership with Repligen for five new high-performance ligands to meet evolving bioprocessing market needs Purolite, an Ecolab company and leading manufacturer of synthetic and agarose-based resins used in the bioprocessing industry, has expanded, and
extended its agreement until 2032 with life sciences company Repligen Corporation to supply five ligands. Repligen is a leading player in bioprocessing and long-time market leader in Protein A, with two facilities that produce the majority of the global Protein A ligand demand to biopharmaceutical customers worldwide. Purolite’s jetting technology is a patented manufacturing method that produces agarose resins used in the purification
of vital therapeutics such as monoclonal antibodies (mAbs). Jetting technology provides Purolite with precise control over bead size and distribution, creating unrivalled lot-to-lot consistency, unique productivity benefits and improved quality for biopharmaceutical developers. Furthermore, the technology significantly reduces lead times and is a greener alternative to traditional manufacturing methods. Building upon a strong foundation of protein A solutions
first commercialized in 2015, this new 10-year agreement will enable Purolite to further expand into the affinity space to provide more solutions for purification of mAbs and mAb fragments that are currently unmet by the market. To read more go to: https://www. lskh.digital/news/leading-resinmanufacturer-purolite-extendsstrategic-partnership-with-repligenfor-five-new-high-performanceligands-to-meet-evolvingbioprocessing-market-needs/
DAY TWO - NEWSLETTER
Exelixis and Catalent Enter into new license agreement for three antibody-drug conjugate programs with the potential to accelerate Exelixis’ Biologics Pipeline
E
xelixis, Inc. (Nasdaq: EXEL) and Catalent, Inc. (NYSE: CTLT) today announced a new license agreement under which Catalent’s Redwood Bioscience subsidiary will grant Exelixis an exclusive license to three target programs with lead antibody
and/or ADC candidates. The ADC candidates have been developed using Catalent’s proprietary SMARTag® technology, and each of the licensed antibodies has potential for development as an ADC or other biologic therapy using a variety of technologies
Samsung Biologics reports third quarter 2022 Financial Results Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization, released today its fiscal year 2022 third-quarter financial results, announcing that the company’s cumulative revenue in fiscal year 2022 surpassed KRW 2 trillion. John Rim, CEO of Samsung Biologics, said: “This past quarter saw strong performance and growth due to a consistent momentum in signing new contracts, helping us meet client demand for integrated offerings and deliver long-term value. Not only have we delivered on our commitments by commencing GMP operations of Plant 4 within just 23 months from
the start of its construction, we have also developed and launched our next-generation bio-technologies – S-DUAL™ and DEVELOPICK™ – which will help streamline and accelerate the antibody development process to save time and cost for our clients.” THIRD QUARTER 2022 RESULTS Samsung Biologics in the third fiscal quarter recorded a consolidated revenue of KRW 873 billion, operating profit of KRW 324.7 billion, and net profit of KRW 129.2 billion. To read more go to: https:// www.lskh.digital/news/samsungbiologics-reports-third-quarter2022-financial-results/
to which Exelixis has access through its partner network. In September 2020, Exelixis and Catalent entered into a separate agreement under which Catalent is applying its SMARTag bioconjugation platform to build ADCs using monoclonal antibodies from
Exelixis’ growing preclinical pipeline. To read more go to: https:// www.lskh.digital/news/ exelixis-and-catalent-enter-intonew-license-agreement-forthree-antibody-drug-conjugateprograms-with-the-potential-toaccelerate-exelixis-biologics-pipeline/
Live from CPHI: ‘Gut microbiome therapy to be approved in the next two years’ The promise of microbiome-based therapeutics is rapidly progressing towards real world applications as treatment of recurrent C. Difficile using faecal microbiota transplant (FMT) edges towards a BLA. Speaking live from CPHI Frankfurt, Christian Roghi, Director of Microbiome Solutions, predicted microbial therapy will be the next big breakthrough in novel therapies, rivalling discoveries like mABs, siRNA and CART-T cells. “We are seeing huge interest in microbiome research, especially in the last five years. There have been a large number of publications describing both the science and the potential benefits of a healthy microbiome,” added Roghi. In total there are some 524
microbiome-based therapeutics – 48% in pre-clinical development and 42% in clinical development – with live biotherapeutics products dominating (177 therapeutics). To read more go to: https://www. lskh.digital/news/live-from-cphigut-microbiome-therapy-to-beapproved-in-the-next-two-years/
DAY TWO - NEWSLETTER The Knowledge Hub TV INTERVIEWS
Indena - Laura Bo, External Communication and Sustainability We have spoken to Laura Bo External Communication and Sustainability Manager at Indena S.p.A to find our more about their focus on sustainability.
To see the whole interview go to: https://youtu.be/ZdYNzu7Ovgs
Axplora - Sylke Hassel CEO NEWS! Here live at CPHI Frankfurt we had the pleasure of interviewing Sylke Hassel CEO at Axplora. Find out more about the newly rebranded company in this interview! To see the whole interview go to: https://youtu.be/Nt8edDYzJ8c
Nanoform CPHI Frankfurt 2022 Check out the video below to learn more about our sustainability initiatives, our exciting collaboration with TargTex and our game-changing STARMAP® Online technology – a finalist for the CPHI awards To see the whole interview go to: https://youtu.be/bWfbvBpyimI