Newsletter | December 7, 2023

12.07.23 -- FDA Warning Letters Dipped, But Don't Get Cozy

FEATURED EDITORIAL

FDA Warning Letters Dipped, But Don’t Get Cozy

Between October last year and March this year, FDA inspectors showed a heightened level of discretion for OAI inspections, choosing to withhold enforcement action. This isn't an invitation to breathe easy; there's a reasonable explanation for less enforcement action.

The 6 Types Of Biopharmaceutical Consultants

In today’s consulting marketplace, there are numerous firms and individuals who consider themselves “consultants,” but, in fact, there are different types of consulting services. Determining which will serve you best is an important decision before you seek support. 

INDUSTRY INSIGHTS

In Silico Approaches Toward Automated Biomanufacturing

As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.

Accelerating Bulk Harvest Testing With A CHO Animal Origin Free Virus Panel

Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.

NEWS HEADLINES

EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization By EC

Formycon Announces EMA Submission For FYB203, A Biosimilar Candidate To Eylea (Aflibercept)

Bio-Thera Solutions Announces Positive Results From Phase 3 Study Of BAT2206, A Proposed Biosimilar Referencing Stelara

Alvotech Announces Positive Top-Line Results From A Pharmacokinetic Study For AVT05, A Proposed Biosimilar For Simponi And Simponi Aria

Samsung Bioepis Secures U.S. License Date For SB17, A Proposed Biosimilar To Stelara

SOLUTIONS

Affinity Resin For Improved Efficiency In Antibody Variant Capture

The Future Of Glass Packaging Is Here

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