Manufacturing

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

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.

The agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

Biosynth has further strengthened its peptide division with the acquisition of Pepceuticals.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Drug efficacy, reputation, and financial return are all on the line when it comes to fill/finish.

A survey was conducted to examine the adoption of machine learning and artificial intelligence in the bio/pharma manufacturing industry.

Using a systematic approach and achieving run-to-run consistency are essential.

The innovation of affinity ligands must take stability into consideration for present and future purification applications.

The steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.

With the two new GMP-grade mRNA manufacturing sites in Germany, MilliporeSigma can now offer fully integrated mRNA services.

Under a new pact, Genentech and PeptiDream will collaborate to discover and develop novel peptide-radioisotope drug conjugates.

The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark.

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

Plasmid DNA (pDNA) is a critical raw material for the manufacture of cell and gene therapies. As this market continues to grow, so too does the demand for high-quality pDNA.

Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Image analysis algorithms coupled with microscopy techniques can be used to characterize aggregates of therapeutic proteins.

Innovations in downstream processing accelerate development, enhance efficiency, and promote sustainability.

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.

In this episode of Drug Digest, industry experts discuss aseptic processing and manufacturing, including what the future holds in this area and the barriers involved with automated aseptic processing practices.

Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.

Webinar Date/Time: Thu, Sep 28, 2023 10:00 AM EDT

Sartorius’ Biostat STR now incorporates Repligen’s XCell ATF hardware.