Intellectual Property and Patents

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.

Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

Under this agreement, Acuitas Therapeutics’ LNP technology platform will be transferred to BIOVECTRA for use in manufacturing mRNA-based therapies.

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

Adherence to detail and thorough project management are required for successful tech transfer and scale up.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

In a goal to boost local pharmaceutical production, the World Health Organization has established a global manufacturing training hub in the Republic of Korea through which Bangladesh, Indonesia, Pakistan, Serbia, and Vietnam will receive mRNA technology.

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.

Model-based approaches and digital analytics are improving flexibility at both the equipment and the manufacturing-line level.

For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

AbCellera’s recent acquisition of the OrthoMab bispecific platform is expected to accelerate antibody product development.

The companies have formed a collaboration to develop a novel human recombinant protein as a therapeutic candidate against COVID-19.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.

A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.

Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.

Successful technology transfer depends on the ability to anticipate risks and plan ahead.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

PDA survey and conference discussion will generate information to guidance on technology transfer.

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.

Modular and podular laboratory and manufacturing allow rapid reconfiguration to support development of drugs for diverse patient populations.

Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.

Rather than isolating the user in a virtual world, mixed reality allows contextualized data to be shared in real time, improving assays, standard operating procedures, workflows, and overall tech transfer.

Experts suggest health care providers and policymakers proceed with caution when exposing patients to the digital pill.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

Real-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.