ISPE

MAY 9, 2023

Smith, PhD Christoph Herwig, PhD 9 May 2023 Are you interested in developing a new bioproduct and attracted by the incredible potentials of new modalities like ATMPs, Cell and Gene Therapies, AAVs, oligonucleotides, multi-specificity antibodies, mRNA vaccines, and more?

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Vaccines 98

ISPE

SEPTEMBER 15, 2023

These technologies are not just trends; they are pivotal tools that enhance manufacturing processes, proactively address quality concerns, and expedite the development of life-saving drugs. QMM is a concept that underscores the pharmaceutical industry's commitment to continuous improvement in quality processes.

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Pharmaceutical Technology

JUNE 29, 2022

This comprises the co-development of core processes and production operations. GenCure will be able to offer a comprehensive solution for cell and gene therapy developers using the reference site. This will expand its portfolio for developers who need assistance with manufacturing and process optimisation.

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ISPE

NOVEMBER 22, 2022

I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. Director of Business Development & Key Account Management, Asia Pacific. Director Aseptic Processing SME. Chervee Ho, Head of Asia Pacific.

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Pharmaceutical Technology

FEBRUARY 23, 2023

“This collaboration will enable us to utilise our cutting-edge GMP plasmid manufacturing platform technology to support the development of mRNA-based Covid-19 vaccine and its therapeutic candidates.” With its technical strength and customer-centric approach, GenScript ProBio will help to accelerate the development of RVAC’s pipeline.”

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Vaccines Communication 115

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Topic sponsors are not involved in the creation of editorial content. This will improve accessibility to services for AAV-mediated gene therapy programmes.

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indispensable health

AUGUST 14, 2023

Clear Communication**: An organized agenda ensures that all topics are clearly outlined. It guides the meeting towards discussing high-priority issues, preventing valuable time from being wasted on less pertinent topics. Time Allocation**: Assign time limits to each agenda item to prevent overindulgence in any one topic.

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Hospitals Patient Care Communication 98

ISPE

AUGUST 15, 2023

This conference will host six tracks on two significant topics for the pharmaceutical industry: 1) Pharma 4.0™ Subject matter experts from the industry will share their knowledge on these topics and address remaining inquiries related to the Annex 1 implementation, adding depth to the ongoing discourse. ™: How do they fit together?”

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Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Topic sponsors are not involved in the creation of editorial content.

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FDA 96

The FDA Law Blog

NOVEMBER 28, 2023

Thus, it’s not entirely surprising that FDA would seek input from a panel on this topic. Is it that the Agency is preparing from this question from labs that are currently offering/developing MCDs? It is well known in the industry that FDA has been skeptical of multi-cancer (sometimes also referred to as pan-cancer) tests.

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FDA 64

Pharmaceutical Technology

DECEMBER 23, 2022

Eli Lilly and Company has expanded a licencing and partnership agreement with ProQR Therapeutics to discover, develop and market new genetic medicines. Topic sponsors are not involved in the creation of editorial content. Optimise your cell therapy process: a guide to cell thawing. Free Whitepaper.

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Communication 131

Pharmaceutical Technology

JUNE 1, 2023

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. It will focus on studying and developing new lipid nanoparticle (LNP) formulations for the delivery of RNA medicine.

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Vaccines 97

Pharmaceutical Technology

JUNE 19, 2023

The pharma company will in-license a small number of gene therapy products and offer research grants to advance them through pre-clinical development. Topic sponsors are not involved in the creation of editorial content. Laurus Labs will be responsible for launching these products in India and emerging markets.

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Pharmaceutical Companies Pharmaceutical Companies 98

Pharmaceutical Technology

DECEMBER 21, 2022

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. Free Whitepaper.

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Vaccines Communication 140

Pharmaceutical Technology

MARCH 28, 2023

Vertex Pharmaceuticals has signed a new non-exclusive licensing agreement with CRISPR Therapeutics to expedite the development of its hypoimmune cell therapies to treat type 1 diabetes (T1D). It edits genes by precisely cutting DNA, then allowing natural DNA repair processes to take over.

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Communication 94

Pharmaceutical Technology

AUGUST 2, 2022

GreenLight’s process from formulation of the drug substance and lipid nanoparticle to bulk drug product can be carried out in this facility. An effective scale-up and fit of GreenLight’s process to Samsung Biologics’ Songdo plant were shown in all comparability data validating with anticipated outcomes.

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Vaccines 104

Pharmaceutical Technology

APRIL 14, 2023

Twist Bioscience has introduced Twist T-cell receptor (TCR) and Twist chimeric antigen receptor (CAR) libraries to facilitate the development of cell therapies. Researchers will now be able to speed up the creation of tailor-made libraries that can help in identifying and developing new cell therapies.

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JUNE 23, 2023

This comprehensive education program provides attendees with technical sessions on the latest developments in supply chain, production and quality systems, sustainability, and cutting-edge industry innovations. This can increase the chances of changing attributes for API or DS during development. and Chugai Pharma Manufacturing Co.

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Pharmaceutical Companies Pharmaceutical Companies 94

The FDA Law Blog

NOVEMBER 29, 2023

See our prior blog post on the topic here. FDA announced that FDA, Health Canada, and MHRA are jointly publishing guiding principles for PCCPs for AI/ML devices to help stakeholders when developing solutions for these countries.

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ISPE

MARCH 30, 2023

These solutions enable progress for the industry as a whole, with considerations for all aspects of development from raw material to the final product. The presentation will describe the Life cycle implemented for the development, release, and maintenance of the Machine Learning algorithm. Industry 4.0,

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ISPE

AUGUST 30, 2023

™, Quality Risk Management (QRM), Contamination Control Strategy (CCS) and Annex 1, Facility Design and Operations, Artificial Intelligence and Machine Learning, and Professional Development. The QRM principles outlined in ICH Q9 are intricate and vital for the advancements of drug development and therapies seen today. The Pharma 4.0™

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Pharmaceutical Technology

MAY 23, 2023

Avrobio will retain complete rights to its HSC gene therapies portfolio developed to treat Pompe disease, Gaucher disease type 1 and type 3, and Hunter syndrome. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

FEBRUARY 16, 2023

The University of Texas MD Anderson Cancer Center has entered a strategic collaboration with biotech company Xilis for advancing new technology and expediting new cancer therapy development. Under the deal, MD Anderson and Xilis aim to advance the development of drug and discovery projects using the MOS technology.

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Communication 96

pharmaphorum

FEBRUARY 9, 2022

This and other trending topics related to Digital Marketing for the new year, will be discussed on February 23 rd at 2:30 CET , at the digital event “ AI Marketing for Pharma ” by Trueblue , an Italian IT company that every day supports the Pharma and Life Science markets at global level.

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JULY 21, 2023

The seminar was organized with opening keynote and plenary presentations followed by three tracks, one for each of the above topics with closing plenary sessions. Ramnarine recently joined Boehringer Ingelheim as Head of Product Management & Development Operations for US Operations.

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Documentation 98

European Pharmaceutical Review

AUGUST 3, 2022

The newly created Working Party’s first task will be to develop a consolidated strategy for future standards addressing these vaccines and their components. Information on this process can be found here. Ghana and Nigeria’s regulatory authorities have already achieved ML3 status.

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Vaccines 93

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. Validation of Cleaning Processes (7/93): Guide to Inspections Validation of Cleaning Processes.” August 2014.

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Pharmaceutical Technology

MARCH 8, 2023

The multi-year collaboration aims to develop new technologies which will help in improving clinical outcomes for patients. The programme aims to develop advanced technologies and applications to improve human health. Topic sponsors are not involved in the creation of editorial content.

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Communication FDA 97

Pharmaceutical Technology

APRIL 3, 2023

The development pipeline of such therapies has been growing strongly and more and more are reaching major milestones,” said René Fáber, member of the executive board and head of the bioprocess solutions division of Sartorius, in a statement. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

JANUARY 17, 2023

Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development. Free Whitepaper.

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Hospitals Chemotherapy Communication Immunization 110

Pharmaceutical Technology

MAY 30, 2023

As part of an exclusive licensing agreement, Amplo Biotechnology secured access to AAV-ColQ data developed by Professor Kinji Ohno’s laboratory at Nagoya University, which forms the basis of the therapy. It also develops adeno-associate virus-based gene therapies for neuromuscular junction disorders.

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The FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. The hope with this new program is that it can similarly benefit the development and review of regenerative medicine therapies.

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FDA Packaging Documentation Labelling 59

Pharmaceutical Technology

MAY 19, 2023

Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. The financing will help to fast-track the development of other in vivo programming candidates into clinical trials.

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Labelling 98

Pharmaceutical Technology

MARCH 20, 2023

RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The partnership will focus on developing potential new vaccines to treat certain selected autoimmune indications, as well as food allergies.

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Vaccines Immunization Communication 98

Pharmaceutical Technology

MARCH 29, 2023

Regeneron Pharmaceuticals has collaborated with Sonoma Biotherapeutics to discover, develop and commercialise new regulatory T cell (Treg) therapies for autoimmune diseases. The two companies will together research and develop T cell therapies for Crohn’s disease and ulcerative colitis, as well as two other undisclosed indications.

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Pharmaceutical Technology

JANUARY 5, 2023

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Topic sponsors are not involved in the creation of editorial content.

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Communication 95

Pharmaceutical Technology

FEBRUARY 9, 2023

The collaboration is aimed at discovering and developing new advanced treatments for genitourinary (GU) tumours as well as other related serious diseases using ReviR’s RNA-targeted technologies. Its initial focus is to develop therapeutics in oncology, CNS, and genetically defined disease indications.

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Communication 96