Manufacturing

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, talks about the differences in designing E&L testing for combination products vs. conventional pharmaceuticals.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, reviews the company’s latest moves in targeting automation.

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India.

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.

Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.

USP offers strategies to minimize residual impurities in downstream processing.

The implementation of Industry 4.0 is projected to save time and cost for designing an optimal manufacturing process.

Interest grows in AI, digitalization, robotics, and sustainability.

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

Sara Fathollahi, PhD, product application specialist at DFE Pharma, makes the case of how excipient suppliers can support the transition from batch to continuous manufacturing.

Sara Fathollahi, PhD, product application specialist at DFE Pharma, discusses a major challenge in the adoption of continuous manufacturing.

Sara Fathollahi, PhD, product application specialist at DFE Pharma, points out important redesign concepts critical to adapting continuous manufacturing.

CPHI Barcelona has strong showing as bio/pharma industry moves confidently into 2024.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

SCHOTT now offers ViewCell, a new component meant to add flexibility to biopharmaceutical process control.

Spark Therapeutics and SpliceBio have formed a collaboration to develop a gene therapy that can treat an inherited retinal disease.

The California Institute for Regenerative Medicine has partnered with Forge Biologics, which will manufacture AAVs to help accelerate gene therapy programs in California.

Wheeler plans to use the facility to bolster its mission in helping fledgling biotech innovators and startups accelerate their development at an equitable price.

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

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

The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.

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.