Author Archives: Dan Stanton

Filtration and single-use drive robust quarter for MilliporeSigma

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Merck KGaA reported a 16% year-on-year growth for its MilliporeSigma Process Solutions business and expects continued strong demand from biomanufacturers to drive high single-digits in the long-term. “Thank you sir, can we have another (Q like this one),†Evercore ISI analyst Luke Sergott wrote in an note describing German Merck’s third quarter 2018. While group sales grew 6.6% year-on-year to €3.7 billion ($4.2 billion), it was the life sciences MilliporeSigma division which really shone. The Process Solutions business unit grew…

November 16, 2018

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

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Marketing unapproved stem cell therapies and cGMP deviations have landed California’s StemGenex Biologic Laboratories with a US Food and Drug Administration (FDA) warning letter. The letter cites issues in good manufacturing practice (GMP) and the unlawful marketing of an unapproved stromal vascular fraction (SVF) stem cell therapy, processed from autologous adipose tissue. It was sent on October 31, following an FDA inspection at StemGenex Biologic Laboratories’ (SGBL) facility in San Diego, California in January this year. According to the Agency,…

November 16, 2018

Staffing shortage leaving blockbuster biologics undeveloped, says expert

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A shortage of bioprocess talent drives high salaries and hinders drug development, says BioPlan Associate’s Eric Langer. As biologics increasingly dominate pipelines, biomanufacturers look to traditional pharma to plug the staffing gaps. Speaking last month at the BIOLive event at CPhI Worldwide in Madrid, Eric Langer, president and managing partner at BioPlan Associates, said hiring is one of the biggest problems facing the biopharma industry. “It is painful [to the biopharma hiring managers] that 40% of the biopharma industry cannot hire…

November 14, 2018

FDA looks to NIPP inconsistent inspections in the bud

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The New Inspection Protocol Project (NIPP) intends to increase the speed and efficiency of sterile injectable facility inspections through the semi-automated generation of establishment inspection reports (EIRs). In efforts to modernize inspections program, the US Food and Drug Administration (FDA) has developed a new protocol to assess, record and report the data from surveillance and pre-approval inspections for sterile drug products. “The New Inspection Protocol Project (NIPP) is focused on modernizing our inspection approach and enabling continual improvement of our…

November 14, 2018

Samsung BioLogics vows to prove innocence as trading suspended

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South Korea’s financial regulator has concluded Samsung BioLogics inflated its value ahead of its initial public offering (IPO) in 2016. The CDMO says it is filing an administrative lawsuit to clearly prove the legality of its actions. In April this year, South Korea’s financial regulators accused contract development and manufacturing organization (CDMO) Samsung BioLogics of accounting fraud, following a yearlong audit. Today the Securities and Futures Commission (SFC) ruled that Samsung BioLogics intentionally violated accounting rules by changing the accounting…

November 14, 2018

BioLife eyes up M&A in ‘fragmented’ regenerative med supply space

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The cell and gene therapy tool supplier space is ripe for consolidation says BioLife Solutions, which is evaluating several acquisition targets. For the third quarter 2018, regenerative medicine consumables and tools firm BioLife reported sales of its biopreservation media product of $5.3 million (€4.7 million), up 79% year-on-year. With the firm also turning a profit of $1.2 million for the period, CEO Michael Rice spoke about the scaling-up opportunities to take advantage of the continued demand from the cell and…

November 13, 2018

Biogen pays $670m to (nearly) match Samsung BioLogics in share of Bioepis

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Biogen has upped its stake in Korean biologics and biosimilar developer Samsung BioLogics from 5.4% to 50%, minus one share. Samsung Bioepis was founded in 2012 and has since been one of a handful of drugmakers to see regulatory success with biosimilar products both in Europe and the US. A joint venture between Korean contract development and manufacturing organization (CDMO) Samsung BioLogics and biopharma firm Biogen, the former has until now been the dominant stakeholder, holding 94.6% of the firm.…

November 12, 2018

Collaboration looks to crystallization as alternative to multi-step chromatography

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A European Union funded project to improve downstream processing is on track for completion by October 2020, says collaborator Fujifilm Diosynth Biotechnologies. The AMECRYS research project, funded through a €3.5 million ($4 million) grant through the European Union’s Horizon 2020 program, has brought together industry with government and academic institutes to develop alternatives to multi-step batch chromatography platforms. One of the collaborators is biologics contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies, which has reached a milestone in the…

November 9, 2018

Jazz on Erwinaze shortage: ‘We can’t sell what we don’t have’

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Jazz Pharmaceuticals says further supply outages for its cancer enzyme Erwinaze are expected amid ongoing manufacturing issues at its sole CMO. For the third quarter 2018, Jazz Pharmaceuticals reported net sales of its acute lymphoblastic leukemia (ALL) drug Erwinaze (asparaginase Erwinia chrysanthemi) of $41 million (€36 million), down 16% on the same period last year. “Supply challenges continued to impact product availability in the third quarter,†CEO Bruce Cozadd told stakeholders on a conference call (transcript here). He predicted further…

November 9, 2018

GE to use Wego to make single-use products in China, for China

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Wego Pharmaceutical Co. will manufacture single-use bioprocessing consumables on behalf of GE Healthcare from its facility in Weihai, China. The partnership with China’s Wego, financial details of which have not been divulged, will decrease product delivery times of GE Healthcare’s single-use bioprocessing products for Chinese biopharmaceutical companies, the firm says. “This collaboration helps local Chinese biomanufacturers focus on bringing much needed therapeutics to Chinese patients,†Olivier Loeillot, general manager of BioProcess at GE Healthcare Life Sciences, told BioProcess Insider. “Local…

November 8, 2018