Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Communication FDA 97

European Pharmaceutical Review

MARCH 5, 2024

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. The analytica conference addresses this topic with a session on the applications of AI algorithms in laboratory medicine. Top topics at the trade fair include digitalisation, Laboratory 4.0,

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Labelling FDA 88

Pharmaceutical Technology

DECEMBER 8, 2022

Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Regulators in Japan have granted approval for the manufacturing plant of Kite in El Segundo, California, US, to produce Yescarta for the Japanese market. Free Whitepaper.

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Communication Immunization Hospitals 122

pharmaphorum

NOVEMBER 30, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) is held on June, 20-21, 2022 in Berlin, Germany. Pharmaceutical Manufacturing & Packaging Congress provides a networking platform for decision-makers from the pharmaceutical industry to share cases and brand-new solutions in one place.

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The FDA Law Blog

OCTOBER 3, 2022

Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic.

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Documentation 105

Pharmaceutical Technology

DECEMBER 14, 2022

Merck and Synplogen have signed a non-binding Memorandum of Understanding (MoU) to expedite the development and manufacturing of viral vector-based gene therapy applications. This platform will aid Synplogen in boosting the speed of clinical manufacturing while lowering process development duration and expenses. Free Whitepaper.

Communication 52

Communication 52

pharmaphorum

NOVEMBER 29, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies.

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Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

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Vaccines 52

Roots Analysis

AUGUST 29, 2023

As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. Overview of Biopharmaceuticals Biopharmaceuticals refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources.

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Roots Analysis

AUGUST 29, 2023

As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years. Overview of Biopharmaceuticals Biopharmaceuticals refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources.

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Pharmaceutical Technology

NOVEMBER 29, 2022

AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “This acquisition represents a unique opportunity to bring innovative science and leading experts in T-cell receptor biology and cell therapy manufacturing together with our internal oncology cell therapy team, unlocking new ways to target cancer. Free Whitepaper.

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Communication 111

Pharmaceutical Technology

AUGUST 22, 2022

Porton Advanced Solutions has raised $80m in a Series B funding round to expand its end-to-end gene and cell therapy (GCT) contract development and manufacturing organisation (CDMO) platforms. By the end of this year or earlier next year, Porton will have a PD, AD and GMP manufacturing facility spread over more than 200,000ft² for GCT. .

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Roots Analysis

AUGUST 9, 2023

It is worth mentioning that in recent years, several healthcare stakeholders have actively undertaken initiatives to incorporate a manufacturing execution system (MES) into their production lines, with an aim to connect, monitor and control the complex manufacturing process.

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Documentation Communication 52

Hospital Pharmacy Europe

AUGUST 17, 2023

Guidance on the provision of CAR T and cellular therapy services in hospital pharmacy has been published by the GoCART Coalition to harmonise implementation across Europe. 10 Once the CAR T-cells are manufactured, they are delivered to hospital pharmacies, making pharmacists central in ensuring appropriate governance and management.

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Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

Pharmaceutical Technology

DECEMBER 12, 2022

The alliance will utilise the capabilities of both firms, including international cell therapy leadership and manufacturing of Kite. Kite will carry out the manufacturing following the technical transfer. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper.

Communication 105

Communication 105

Pharmaceutical Technology

MARCH 3, 2023

With over 18 years of experience, Alexander Dragitsch is a commercial customer service contract manufacturing (CSCM) manager at Baxter’s Halle/Westfalen facility in Germany. The Halle customer service team is a “one-stop-shop” for client requests when it comes to commercial drug product manufacturing,” explains Dragitsch. “The

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Customer Service Documentation 52

Fuld

NOVEMBER 29, 2022

A leading manufacturer of multiple infectious disease vaccines used Fuld & Company’s competitive monitoring services to gain a clear view of the evolving competitive landscape. ? Used a customized schedule of monthly topics to report on a quarterly basis to give the client flexibility based on the dynamics of the market. ?.

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Vaccines 52

Pharmaceutical Technology

APRIL 17, 2023

Australian pharmaceutical company Incannex has appointed Quest Pharmaceutical Services (QPS) to advance CannQuit-N (Nicotine), CannQuit-O (Opioid) and Renecann Products in the USA and the European Union (EU). QPS was established in 1995 to provide bioanalytical LC-MS/MS contract services.

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Immunization Pharmaceutical Companies Pharmaceutical Companies FDA 52

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. Topic sponsors are not involved in the creation of editorial content.

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Vaccines Immunization Hospitals 52

Pharmaceutical Technology

MARCH 27, 2023

It intends to use a part of the financing to implement innovative manufacturing platforms and technologies which help in increasing the vaccine supply speed, strengthening the domestic supply chain, and reducing cost. Topic sponsors are not involved in the creation of editorial content.

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Vaccines Communication 52

European Pharmaceutical Review

OCTOBER 5, 2023

Ahead of her presentation on the future of biomanufacturing at CPHI Barcelona, Sheila Ann Mikhail, the co-founder and former CEO of AskBio, engages in a conversation about gene therapy, artificial intelligence, and the importance of being a well-informed innovator when selecting a manufacturing partner.

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Immunization 85

Pharmaceutical Technology

MAY 2, 2023

Marker Therapeutics has reached a non-dilutive agreement to sell cell manufacturing assets to CellReady for $19m in cash. CellReady is a newly created contract development and manufacturing organisation (CDMO) founded by Marker board member and co-founder John Wilson. Both firms expect to complete the deal on 26 June 2023.

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Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.

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ISPE

SEPTEMBER 1, 2023

But are they safe for sensitive industries like pharmaceutical manufacturing? 1 Important to Note: In the context of industrial processes and manufacturing, plant process management (PPM) refers to the systematic planning, implementation, and control of processes to ensure efficiency, quality, and productivity in a production environment.

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Communication Documentation 98

Pharmaceutical Technology

JANUARY 12, 2023

The collaboration will use the vector biology, manufacturing capabilities and the drug development experience of Solid Biosciences and Phlox Therapeutics’ knowledge in genetic cardiomyopathies and RNA therapies. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper.

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Communication 52

Pharmaceutical Technology

JANUARY 20, 2023

Increasing manufacturing capacity for pandemic prevention “The other piece we are working on is … how do we build manufacturing capacity around the world?”, The biotech has also made plans to expand manufacturing capacity elsewhere. The manufacturing expansion plans go beyond Covid-19 vaccines and therapeutics. “We

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Vaccines Communication FDA 98

ISPE

MARCH 30, 2023

A presentation from Robin Blankenbaker, Lifesciences Industry Lead at Siemens Digital Industries Software, will demonstrate a digital thread of data sources from R&D through commercial manufacturing. End-to-end digital twins of the manufacturing process are increasingly important tools for process development and characterization.

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Documentation 98

Pharmaceutical Technology

MARCH 1, 2023

Vertex will also handle all subsequent development, manufacturing, and commercialisation activities. By combining Tevard’s ability to restore the production of critical proteins with Vertex’s clinical, regulatory, and manufacturing expertise, we hope to make an important difference for patients and their families.”

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Communication 52

ISPE

JULY 24, 2023

But are they safe for sensitive industries like pharmaceutical manufacturing? Many pharmaceutical manufacturers are hesitant to trust their data to the cloud. Few pharmaceutical manufacturers have the cybersecurity expertise on staff to design, implement, and sustain a comprehensive cybersecurity program. How is data backed up?

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Communication Documentation 98

Fuld

MAY 15, 2023

Please reach out if you would like to discuss how these topics are relevant to your business. Tesla Energy is set to become one of, if not the, largest global manufacturer of grid-scale storage systems by the end of 2024. I’d love to hear your feedback on the issues covered in this month’s newsletter. Learn how we can help.

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Pharmaceutical Technology

MAY 12, 2023

It works with NYBC’s researchers, manufacturing teams and operations staffs. NYBC Ventures provides companies more than capital, offering access to world-renowned researchers and their labs, cell manufacturing capacity and source materials.” Topic sponsors are not involved in the creation of editorial content.

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Roots Analysis

AUGUST 7, 2023

In addition, various medical device manufacturers are using novel surface modification technologies to enhance the physiochemical properties, frictional resistance, and, in certain cases, layout of the substrate, adding on to the device properties. over the coming decade.

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Adverse Reactions 52

Pharmaceutical Technology

MAY 17, 2023

AGC Biologics has introduced the BravoAAV and ProntoLVV viral vector platforms that offer quick clinical and commercial production and release of good manufacturing practices (GMP). Both platforms use the company’s development, manufacturing and analytical capabilities in lentiviral vector (LVV) and adeno-associated viral vector (AAV).

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Pharmaceutical Technology

JUNE 2, 2023

The company is a global contract development and manufacturing organisation (CDMO) for biopharmaceuticals. It offers complete a range of services, including bioprocess development to cGMP manufacturing, for the clinical supply of AAV at its Stevenage facility. Topic sponsors are not involved in the creation of editorial content.

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Roots Analysis

AUGUST 1, 2023

In regard to this aim, supply agreements , distribution agreements, technology integration agreements, purchase agreements, capability expansions, R&D agreements and service alliances have been reported in this market, as the manufacturers strive to become one-stop-shops, to cater to the diverse needs for their clientele.

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Vaccines 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna will also assume further development, manufacturing, and commercialisation responsibilities on exercising a target option. Topic sponsors are not involved in the creation of editorial content. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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Communication 59

Roots Analysis

AUGUST 7, 2023

Cell Free System Market Landscape It is worth mentioning that, currently, more than 35 players, which claim to offer services for cell-free synthesis. Further, majority of the service providers offer biomolecule synthesis services followed by a substantial number of companies offering services for template construction.

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