Wednesday, May 15, 2019 Daily Archives

Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle

by , , , and

Biopharmaceutical manufacturing processes that were developed before the implementation of quality by design (QbD) typically use control strategies that are not founded on a formal understanding of criticality. Thus, manufacturers of “legacy†products lack the understanding of critical process parameters (CPPs) and critical quality attributes (CQAs). Introducing such elements to a legacy biologic drug product filing aligns fully with expectations described in the ICH Q12 guideline (e.g., increased process understanding and better risk mitigation strategies) (1). Here we discuss how…

May 15, 2019

Integrity Redefined: Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety

by , , and

With the increasing adoption of single-use systems (SUS) in critical stages of biopharmaceutical manufacturing, any lack of system integrity can significantly affect drug product quality and patient safety, as well as incur additional costs due to product loss and disrupted production cycle. This article from Sartorius Stedim Biotech, describes how determining the correlation between liquid leakage and microbial ingress can be used to define MALLs (Maximum Allowable Leakage Limits) of SUS for different process steps. The article also details the…

May 15, 2019

Funding Pediatric Cancer Drug Development

by

Why is it so hard to develop drugs for children with cancer? And what can be done about it? Those questions are central to a Massachusetts Institute of Technology (MIT) study published in JAMA Oncology exploring new business models for funding drug development to treat pediatric cancers (1). Led by Andrew W. Lo (the Charles E. and Susan T. Harris professor at and director of MIT’s Laboratory for Financial Engineering) finds that a collaborative investment structure involving money from private-sector,…

May 15, 2019

ElevateBio proposes centralized model for cell & gene startups

by

Neither a CDMO nor an end-user, ElevateBio is looking to change the paradigm in cell and gene therapy development through it’s a centralized R&D and manufacturing model. Recently launched through a $150 million (€134 million) Series A financing, ElevateBio intends to create and grow a portfolio of cell and gene therapy companies using shared expertise and facilities through its R&D, process development and cGMP manufacturing subsidiary Basecamp. “BaseCamp is not a CDMO [contract development and manufacturing organization],†ElevateBio’s CEO David…

May 15, 2019

CDMO round-up: News from Patheon, Samsung and Sekisui

by

Patheon will produce an antibody for Cantargia; GI Innovation has signed a second development services deal with Samsung BioLogics; Sekisui Diagnostics is growing its contract microbial manufacturing business. Welcome to Bioprocess Insider’s CDMO round-up. First up in our contract development and manufacturing organization (CDMO) round-up is news from Thermo Fisher’s Patheon, which has been selected to produce CAN04 (nidanilimab) for Cantargia AB. Cantargia already has a contract in place with Celonic (formerly Glycotope Biotechnology) for clinical supply of the monoclonal…

May 15, 2019

MilliporeSigma and Thermo contribute to Biolife’s ‘blowout’ Q1

by

Distributors STEMCELL Technologies and VWR also cited as sales of Biolife Solutions’s bio-preservation media and automated thawing products increased 51% year-on-year. For the first quarter 2019, Biolife, which makes and supplies biopreservation media and automated cell thawing media devices for cell and gene therapies, reported record revenues of $5.8 million (€5.2 million). “Dead cells don’t cure cancer, and the combined therapeutic, and economic risks our customers are facing should broaden use of our products as a best practice in the…

May 15, 2019

Pfizer opens $200m clinical manufacturing plant in MA

by

The multiproduct facility will support early-phase manufacturing for its biologics pipeline, Pfizer says. Last week, pharma giant Pfizer cut the ribbon on the latest addition to its biomanufacturing network in Andover, Massachusetts. The Andover Clinical Manufacturing Facility (ACMF) represents an investment of $200 million (€178 million), which includes construction, additional processing equipment and qualification, according to Pfizer spokesperson Samantha Reardon. “The multi-product facility is designed to deliver early phase clinical supplies for Pfizer’s extensive biological portfolio,†she told Bioprocess Insider.…

May 15, 2019

Fungal infection? Biopharma embrace boosts Dyadic’s high titer platform

by

Dyadic Internationally has struck three deals in two weeks as its industrially-proven fungus-based expression system receives the attention of biotech and Big Pharma. Dyadic reported a busy first quarter 2019 with R&D revenues of $403,000 (€359,000), more than double the same period 2018. The firm also updated investors on recent activity, specifically a wave of deals over the past few weeks supporting its C1 gene expression platform. In April, Australia’s Luina Bio struck a sub-licensing deal with Dyadic, and a…

May 15, 2019