ISPE

MAY 10, 2023

The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment, including background to safe working levels, mechanisms of exposure, and how exposure can be controlled. Containment (engineering controls) are amongst the preferable measure to be taken. Hoffmann-La Roche Ltd.

Compounding 52

Compounding Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 12, 2022

Primary Packaging Development. Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives. Delve into the considerations for material components for the development of primary packaging. Connected Drug Delivery Devices.

Packaging 52

Packaging 52

Pharmaceutical Technology

AUGUST 25, 2022

Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. A cGMP-compliant production facility will be housed at the centre for manufacturing cell products at scale.

Immunization 52

Immunization 52

Pharmaceutical Technology

AUGUST 11, 2022

GentiBio and Bristol Myers Squibb (BMS) have signed a multi-year partnership agreement for developing new engineered Treg therapies for inflammatory bowel disease (IBD) patients. These therapies will be developed for re-instating immune tolerance and repairing tissue in IBD.

Immunization 52

Immunization 52

Pharmaceutical Technology

JULY 6, 2022

The mRNA technology was used for the development of the Covid-19 vaccine. In a press statement, CureVac said: “CureVac does not seek an injunction nor intend to take legal action that impedes the production, sale or distribution of Comirnaty by BioNTech and its partner Pfizer.”.

Vaccines 72

Vaccines 72

Pharma Marketing Network

JULY 19, 2023

Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales. In the pharmaceutical industry, content marketing can be particularly effective for driving sales.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies 98

Pharmaceutical Technology

MARCH 8, 2023

The multi-year collaboration aims to develop new technologies which will help in improving clinical outcomes for patients. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Communication 97

Communication FDA 97

Pharmaceutical Technology

DECEMBER 8, 2022

Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. The delivery of the product is anticipated to begin early next year. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Free Whitepaper.

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Communication Immunization Hospitals 122

Pharmaceutical Technology

SEPTEMBER 29, 2022

Scribe Therapeutics and Sanofi have signed a strategic partnership to expedite the development of breakthrough clustered regularly interspaced short palindromic repeats (CRISPR)-based cell therapies for cancer. Scribe is also entitled to receive potential payments worth over $1bn on meeting development and commercial milestones.

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Pharmaceutical Technology

MAY 3, 2023

BrightPath will obtain non-exclusive rights to the STAR-CRISPR editing platform of Artisan Bio for accelerating the development of BrightPath’s iNKT cells. Artisan will receive an upfront payment and research milestone payments, along with licence fees and development milestones from BrightPath.

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Pharmaceutical Technology

JANUARY 4, 2023

Cell-engineering company MaxCyte has signed a strategic platform licence (SPL) with biotechnology company Catamaran Bio to support the chimeric antigen receptor (CAR)-NK cell therapy programmes. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Free Whitepaper.

Communication 52

Communication 52

pharmaphorum

FEBRUARY 25, 2021

This one-of-a-kind event brings together global leaders in the Drug Delivery Technology and Medical Devices field for an intensive one-day meeting on the latest updates and innovations for device developers.

FDA 52

FDA 52

Pharmaceutical Technology

APRIL 27, 2023

Bristol Myers Squibb will take over a former Novartis plant to boost viral vector production for chimeric antigen receptor (CAR) T-cell therapies. Bristol Myers Squibb stated that the facility will provide viral vector production capabilities for its two CAR T-cell therapies. This process is both operationally and technically complex.

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pharmaphorum

JANUARY 24, 2022

Highly Potent Active Pharmaceutical Ingredients. The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety. 9th and 10th May 2022. London, UK. www.highlypotentapi.com/pharmaphorum.

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pharmaphorum

JULY 22, 2022

SAE Media Group are pleased to announce the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference. An event that focuses on cleanroom technology in the pharmaceutical industry, the conference will serve to bridge that gap between the two areas while simultaneously providing a unique selling point. Advances in Pharma 4.0

Compounding Pharmacies 52

Compounding Pharmacies Compounding 52

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. These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets.

Vaccines 52

Vaccines 52

Hospital Pharmacy Europe

AUGUST 17, 2023

In CAR T-cell therapy, which is classified as an advanced therapy medicinal product, autologous T-cells are genetically engineered ex vivo to express CARs that direct the patient’s lymphocytes to kill the tumour cells. Operational considerations Section 2 highlights operational considerations in the patient and product pathway.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

ISPE

JULY 19, 2023

Nearly 500 participants attended either in person or online to learn about the latest developments. has taken on significantly increasing momentum in the pharmaceutical industry. ™ is now probably the most important industrial approach or pharma manufacturing, particularly for sterile and aseptic products.

Documentation 98

Documentation FDA Labelling Communication 98

ISPE

FEBRUARY 7, 2023

The two-day conference on 31 January–1 February featured a range of sessions on topics including biomanufacturing, cell and gene therapy, digital transformation and Pharma 4.0™, Hartman noted the importance of attendees’ work in bringing pharmaceuticals to patients. ™, emerging technologies, and facility design and construction.

Vaccines 88

Vaccines Dosage Hospitals 88

Pharmaceutical Technology

AUGUST 26, 2022

ElevateBio has signed a long-term strategic collaboration with the University of Pittsburgh, US, to establish a biomanufacturing centre for expediting cell and gene therapy development. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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ISPE

OCTOBER 28, 2022

Communities of Practice Profiles: Shaping the Future of the Combination Products Industry. Communities of Practice Profiles: Shaping the Future of the Combination Products Industry. Combination Products is one of ISPE’s newest Communities of Practice (CoPs). Combination Products Consulting Services LLC. Trudy Patterson.

FDA 52

FDA 52

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. The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan. Free Whitepaper.

Communication 52

Communication 52

Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

FDA 52

FDA 52

pharmaphorum

NOVEMBER 17, 2021

The Future of Drug Delivery and Combination Product Device Design. The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products.

Packaging 52

Packaging 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna has entered a strategic research and development partnership with ElevateBio’s Life Edit Therapeutics to discover and develop new in-vivo mRNA gene editing therapies. Moderna will also assume further development, manufacturing, and commercialisation responsibilities on exercising a target option.

Communication 59

Communication 59

ISPE

MARCH 8, 2023

Introducing CoP Leader Profiles: Rachel Owen Trudy Patterson Wed, 03/08/2023 - 09:46 InTouch March / April 2023 Introducing CoP Leader Profiles: Rachel Owen Marcy Sanford 1 March 2023 With this issue, Pharmaceutical Engineering ® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders.

Controlled Substances 52

Controlled Substances 52

Pharmaceutical Technology

JANUARY 10, 2023

Boehringer Ingelheim has entered a strategic partnership and licensing agreement with 3T Biosciences for the discovery and development of next-generation cancer immunotherapies. This leads to the production of tumour-specific and safer therapies that can be provided at higher doses. Free Whitepaper.

Immunization 52

Immunization Compounding Communication 52

ISPE

OCTOBER 26, 2022

During this 90-minute session, complementary industry perspectives from equipment/autonomous facilities providers and biopharmaceutical manufacturers will be respectively provided by Dennis Powers, Vice President, Business Development & Design Consulting, G-CON and Richard Panton, Principal Engineer, Roche/Genentech. O'Brien, PhD.

FDA 52

FDA 52

ISPE

NOVEMBER 23, 2022

Development of the Regulatory and Quality track was led by Ciby Abraham, Senior Director and Group Manager, Project and Product Leadership, AstraZeneca who is a member of the RQHC North America Regional Group; and Connie Langer, CMC-Global Regulatory, Pfizer, who is a member of the PQLI Committee’s Q12 Implementation team.

FDA 52

FDA Documentation 52

ISPE

MARCH 6, 2023

Sustainability Definitions for the Pharmaceutical Industry Trudy Patterson Mon, 03/06/2023 - 10:26 Features March / April 2023 Sustainability Definitions for the Pharmaceutical Industry William G. while meeting patient needs as a primary goal.

Communication 52

Communication Patient Care 52

ISPE

SEPTEMBER 11, 2023

Cauchon, PhD 1 September 2023 The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance. McQueen Nina S.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 28, 2023

With multiple geopolitical and pandemic related challenges in recent years, having a robust supply chain has increasingly become a strategic advantage for the pharmaceutical industry. The pharmaceutical supply chain runs through the entire process of new drugs from innovation to clinical to approval.

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 28, 2023

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

ISPE

APRIL 12, 2023

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. This is one of the most critical success factors for biotech companies and their products.

Documentation 98

Documentation FDA 98

Pharmaceutical Technology

APRIL 5, 2023

This includes the first potential approval of a CRISPR-based gene therapy called exa-cel , which is developed by CRISPR Therapeutics and Vertex Pharmaceuticals. In an exclusive interview with Pharmaceutical Technology , Bruce Levine, PhD, talks about the past, present, and future of CAR-T therapies and what challenges lie ahead.

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FDA Immunization 59

ISPE

JULY 10, 2023

But can we imagine applying a tool like ChatGPT in a safety-critical, product-related environment? ChatGPT : “Yes, ChatGPT can be useful in regulated areas of the pharmaceutical industry, such as providing information on drug products, their uses, dos-ages, side effects, and interactions with other medications.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

SEPTEMBER 4, 2020

With increasing demand for self-administration, a rise in biologics, large-volume delivery and the delayed EU MDR at the forefront of the field, SMi’s 13th annual event will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry.

Packaging 52

Packaging 52