Author Archives: BPI Staff

How Are Service Companies Responding to the Increased Interest in New Modalities, and What Regulatory and Market Hurdles Still Exist?

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Moderator Dan Stanton, with Juan Cordova (Abzena), Dawn Ecker (BDO), and Scott Miller (Carbogen Amcis AG) Moderator Dan Stanton led the second roundtable discussion at the BPI Theater at CPhI, which focused on emerging therapies and specifically how service companies are responding to the increased interest in developing new modalities. More Monoclonal Antibodies In Ecker’s presentation earlier that afternoon, her data had suggested that monoclonal antibodies (MAbs) have not yet peaked. Stanton began by asking the panelists to comment on…

July 11, 2019

How Has Single-Use Increased Access to Biomanufacturing Solutions for Both CDMOs and End-Users?

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On Wednesday, May 1, 2019, Dan Stanton moderated a CPhI Theater roundtable discussion focused on single-use technologies’ solutions for the biomanufacturing industry. Panelists Scott Patterson, Vice President of Commercial Sales at ILC Dover, and David Lyon, a senior research fellow Lonza Pharma, explored whether process sponsors and manufacturers will continue to prefer consumables to stainless steel equipment and how that preference might create new markets and therapies. Watch the full roundtable discussion below and leave your thoughts or questions on…

July 11, 2019

Where Are Today’s Biomanufacturing Bottlenecks and How Is Industry Looking to Overcome Them?

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Moderator Dan Stanton, with Ramon LeDoux (YMC Process Technologies), Courtney Morgret (AbbVie), and Kiran Chin (MKA Insights) Moderator Dan Stanton began the discussion by talking about bottlenecks within manufacturing. “The term bottleneck brings up imagery that describes the sort of problems we have when it comes to the manufacturing flow,†he stated. He posed the first question to Kiran Chin: “Your presentation highlighted companies that ask the right questions, and you spoke of the importance of doing so when it…

July 11, 2019

At What Point in Drug Development Must a Firm Look to Process Optimization, and How Critical is this Timing to a Product’s Overall Success? A Roundtable Discussion

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Moderator Dan Stanton, with Kelsey Achenbach (Roquette), Andy Davies (Prometic Bioseparations), and Eric Langer (BioPlan Associates) Dan Stanton initiated the final roundtable of the 2019 BPI Theater at CPhI by asking panelists about process optimization. “Why has it entered the mainstream of parlance within the biopharmaceutical industry?†  Achenbach defined process optimization as anything that improves a process, typically from a cost perspective. The term interests many people in the industry now because it is at a stage where such…

July 11, 2019

Single-Use Technology for Containment During ADC Handling

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Scott Patterson, vice president of commercial sales, ILC Dover Antibody–drug conjugates (ADCs) are increasing in popularity, with a robust pipeline that could lead to a US$10-billion market over the next several years. These novel treatments combine the high potency of small molecules with the targeting ability of monoclonal antibodies (MAbs). However, the challenge of such treatments is that they combine a highly potent, toxic material with a large protein that will target a treatment area. As a result, manufacturing the…

July 11, 2019

Investment digest: News from Pfizer, Bayer and Altimmune

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Pfizer has completed its $340 million Theracon buy, Bayer pumps $250 million into allogeneic stem cell venture, and Altimmune set to buy NASH drug developer. Welcome to Bioprocess Insider’s investment round-up. First up, Pfizer has added Therachon Holding AG to its business, bringing it assets in development for the treatment of achondroplasia and short bowel syndrome (SBS). The deal, announced in May, saw Pfizer shell out $340 million (€300 million) upfront for the Swiss biotech but the Big Biopharma could…

July 10, 2019

Ohr pushes for oligonucleotide merger with NeuBase

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Ohr Pharmaceutical has urged its shareholders to vote for a merger with Neubase Therapeutics at a special meeting this week, creating an entity focused on RNA gene silencing. The reverse merger, first announced in January, would create a public company focused on advancing NeuBase’s peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) technology platform for the development of therapies to address severe diseases caused by genetic mutations, including Huntington’s disease and myotonic dystrophy. However, the deal is at risk of not going…

July 5, 2019

Amicus contracts Thermo Fisher to make Batten disease gene therapy

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Brammer Bio, now part of Thermo Fisher, will provide clinical and commercial manufacturing capabilities for gene therapy developer Amicus Therapeutics. Under terms of the deal, Amicus has teamed with Thermo Fisher to support its intrathecal AAV Batten disease gene therapy programs. The agreement includes production of Amicus’ clinical candidates CLN6 and CLN3, with production set to be transferred to Thermo Fisher’s manufacturing sites in Alachua, Florida, and Cambridge, Massachusetts The contract is “a significant next step in fulfilling our manufacturing…

July 2, 2019

Henlius’ trastuzumab: EU to assess first China-made biosimilar

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The European Medicines Agency (EMA) has accepted to review a version of Roche’s cancer drug Herceptin (trastuzumab) developed by Chinese biotech Henlius. The European agency has officially accepted to review the Marketing Authorization Application (MAA) of Shanghai, Henlius’ trastuzumab molecule HLX02, making it he first biosimilar developed and made in China to be up for review. Scott Liu, co-founder and CEO at Henlius, said the review “shows that our clinical, medical, regulatory affairs and quality system capabilities have been internationally…

June 25, 2019

Biotech money: Global funding down despite spate of IPOs

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A decline in venture capital (VC) funding has been offset by a flood of IPOs with growth coming from non-US biotechs, according to a Jefferies analyst. For April and May 2019, biotech funding has declined 6.5% year-on-year to $9.3 billion (€8.3 billion) according to Jefferies analyst David Windley. This, he said in a note, is due to a 46% drop in VC funding as the private market continues to be less kind to biotech over the past few periods. “Both…

June 21, 2019