Author Archives: Dan Stanton

Biocon going digital to fix insulin plant hit with another FDA 483

Adopting a digital-based Quality Management System will help Biocon remediate issues at its insulin glargine facility in Malaysia, the firm says. An inspection by the US Food and Drug Administration (FDA) between June 24 and July 5 has resulted in a Form 483 with 12 observations at Indian drugmaker Biocon’s facility in Malaysia. The drug product and drug substance site will produce a follow-on insulin glargine referencing Sanofi’s Lantus intended for the US market. “We believe these 12 observations across…

M&A hungry BioLife to buy cold-chain services firm SAVSU

Having gradually increased its stake in the cloud-based cold-chain management firm, BioLife Solutions will buy the remaining 56% of shares to bolster its cell and gene therapy offering. Supplier of cell and gene therapy tools BioLife has been experiencing huge growth over the past few quarters (51% increase year-on-year for its Q1 2019, for example) due to the high demand for bio-preservation media and automated thawing products. The firm has been looking to take advantage of the continued demand from…

CDMO Celonic jumping into cell & gene therapies with €50m plant

Following a €50 million ($56 million) investment in its biomanufacturing capabilities, Celonic is spending a similar amount to propel itself into the commercial cell and gene therapy space. Contract development and manufacturing organization (CDMO) Celonic announced last year the construction of a GMP facility at its site in Heidelberg, Germany, increasing clean room area by approximately 2,000 square meters to support clients’ Phase III and commercial biologics programs. CEO Konstantin Matentzoglu told Bioprocess Insider on stage at BIO that the…

Teva partnership looks to up its biologics productivity

Teva has teamed with Just Biotherapeutics to develop a high productivity biomanufacturing process as it focuses its efforts towards biopharmaceuticals. The partnership aims to develop methods to lower the cost of biomanufacturing. Just Biotherapeutics – recently acquired by Germany’s Evotec – will design and development a high yielding manufacturing process for one of Teva Pharmaceutical Industries’ complex products. Further details of the process, molecule or the finances of the deal were not answered by either company when contacted by this…

Fujifilm investing $30m into cell culture media plant in Netherlands

Fujifilm Irvine Scientific says a third facility at its Tilburg site will help meet future demand for cell culture media from biomanufacturers. Plans have been laid for a 250,000 square-foot building at Fujifilm’s site in Tilburg, The Netherlands to produce a range of media for the biomanufacturing space. When operations begin – expected late 2021 – the plant will increase Fujifilm Irvine Scientific’s production capacity by 320,000 Kg per year for dry powder, and 470,000 L per year for liquids.…

Spark on the evolving commercial cell & gene therapy space

Single-use technologies and CDMO expansions have resolved some of the issues in the cell and gene therapy space but analytical and supply chain challenges still exist, says Spark Therapeutics. Spark Therapeutics is one of a handful of companies to achieve regulatory success with an advanced therapy, specifically its gene therapy for inherited vision loss Luxturna (voretigene neparvovec) which received US approval in December 2017. Speaking as part of a panel discussion at the BPI Theater at BIO in Philadelphia last…

Lonza takes parenteral control through Novartis plant buy and contract

CDMO Lonza has acquired a fill & finish facility in Switzerland from big pharma firm Novartis it says boosts its end-to-end offering. The deal sees contract development and manufacturing organization (CDMO) Lonza take over the reins at fellow Swiss firm Novartis’ sterile, multi-product drug product facility in Stein. Lonza will retain operational and management staff at the site and manufacture clinical drug product for Novartis. Financial details have not been disclosed. “The facility can handle liquid and lyophilized dosage forms…

Catalent Novavax deal ups Paragon gene therapy footprint by 65%

The $18 million acquisition is a drop in the ocean compared to the Paragon Bioservices buy but demonstrates Catalent’s appetite to push ahead in the gene therapy space. The $18 million (€16 million) deal sees contract development and manufacturing organization (CDMO) Catalent – through its gene therapy unit Paragon – take over the leases of two facilities in Rockville and Gaithersburg, Maryland from vaccine firm Novavax. All related manufacturing equipment and over 100 of Novavax’ employees will transfer to Paragon.…

AbbVie: Lack of Botox biosimilars a factor in $63bn Allergan buy

AbbVie, a firm all too familiar with biosimilar threats, says the low risk of Botox competition was a factor in its decision to acquire Allergan. The agreed $63 billion (€55 billion) megamerger with Allergan strengthens AbbVie’s pharma assets and provides the firm with a healthy growth platform, Bioprocess Insider reported last week. Allergan’s lead product neurotoxic protein Botox (botulinum toxin) brought in $3.6 billion in sales revenue in 2018 and will add immediate add scale to AbbVie in neuroscience, as…

Stem cell clinic compliance slower than expected, says FDA

The US FDA continues its clampdown on unapproved stem cell therapies but says the pace of progress in making clinics comply is slower than expected. In November 2017, the US Food and Drug Administration (FDA) laid down a comprehensive regenerative medicine framework aimed at spurring innovation and access to potentially transformative products, while ensuring safety and efficacy for such products. This included warnings against providers of unapproved and unproven stem cell therapies, and a period of a risk-based approach to…