Technology Transfer

Waters’ acquisition of Prosolia’s DESI technology boosts its mass spectrometry imaging portfolio.

Nik Leist’s keynote address will explore the manufacturing of digital medicines at the CPhI North America 2018 conference in Philadelphia, PA, on Wednesday, April 25, 2018.

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.

Honeywell offers an augmented/virtual reality approach to train the industrial workforce.

While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

The VERSA Telemanipulator from Central Research Laboratories (CRL), a Destaco company, is suited for remote-handling applications that involve specific customization requirements.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \

The author reviews some of the key considerations when selecting a vendor and crucial parameters that must be defined in the tech-transfer process to ensure the greatest chance of success.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

Ties between the biotechnology industry and university research are crucial.

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.