Why is aseptic processing important in pharmaceutical manufacturing? The manufacturing of both sterile drugs and biological products can be achieved through terminal sterilization or aseptic ...

Course covers core operational pillars including Contamination Control Strategies (CCS), environmental monitoring programs, barrier technologies (RABS and isolators), cleanroom classification, aseptic ...

August Bioservices’ Ryan Downey discusses fill-finish capacity, Annex 1 readiness, technical expertise and the infrastructure ...

Lee, MA, March 28, 2023 (GLOBE NEWSWIRE) -- Berkshire Sterile Manufacturing (BSM), a fill finish CDMO located in Lee, MA, recently completed their first GMP fill using their new low loss fill process.

Sterile manufacturing refers to the method of producing medications in which the drug product, container, and closure are meticulously sterilized before being distributed. The pharmaceutical sector ...

According to the National Cancer Institute, immunotherapies that enlist and strengthen the power of a patient’s immune system are the “fifth pillar” of cancer treatment adding to surgery, chemotherapy ...

Driven by a forecasted pharmaceutical market expansion through 2034, demands for flexibility and product safety in sterile ...

DURHAM, N.C.--(BUSINESS WIRE)--Patheon N.V (NYSE: PTHN), a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma sectors, announced that ...

Shawn Kinney, the co-founder and CEO of Berkshire Sterile Manufacturing, says the company's one-of-a-kind filling system contains features that are particularly useful for drugs that are especially ...

After years of manufacturing woes, Pfizer appeared to turn a corner earlier this year for its growing sterile injectables portfolio. But even with signs trending upward, Pfizer is preparing to exit an ...

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for violations of current good manufacturing practices (CGMP) and for marketing ...