Insights On Pharmaceutical Production

31. 5 Questions To Ask Before Selecting A Process Data Analytics Solution 1/7/2019

    The data generation and collection strategies at the center of manufacturing processes have evolved dramatically, especially in recent years. Process manufacturers now collect and store huge volumes of data throughout their operations, both on and off premise, across multiple geographic locations, in an increasing number of separate data silos. In this paper, we propose five questions we believe every process manufacturing buyer should ask when evaluating a data analytics solution.

32. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations 6/10/2019

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

33. Track-And-Trace In The Drug Supply Chain 3/21/2019

    Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. 

34. Single-Use Systems For Vaccine Manufacturing 10/29/2019

    Next-gen vaccines will leverage recombinant approaches and intensified single-use systems (SUS) to increase capacity at reduced costs, but SUS suppliers will need to overcome regulatory challenges.

35. Using A CMO To Streamline Process Characterization 3/19/2019

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

36. CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy 5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

37. Grifols New Manufacturing Facility Provides Contract Development And Manufacturing Solutions For Recombinant Proteins 5/3/2019

    Grifols' Consolidated Manufacturing Facility (CMF) is a flexible, multiproduct facility with available manufacturing capacity that created an opportunity to leverage their existing technical expertise and commitment to quality to provide contract services to biopharma companies as a recombinant protein CDMO and support the development of innovative therapies. We recently spoke with Paul Magreta at Grifols about their new $80 million manufacturing facility in Emeryville, California, and the CDMO Services they offer. 

38. Evolving Containment In Pharma Manufacturing Facilities 5/26/2020

    Pharmaceutical manufacturing is now undergoing significant transformation. COVID-19 and its pressure on nearly every aspect of human life has put a gigantic emphasis on rapid development of prescriptives, vaccines, and accelerated means for pharmaceutical mass-production. This paper characterizes the new production directions in pharmacy and describes flexible equipment to improve pharma efficiency, purity, and production safety in the coming decade.

39. Viral Clearance: The Basics On How To Conduct Effective Studies 5/17/2019

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

40. Downstream Process Development For Efficient Purification Of Adenovirus 9/10/2018

    Here, we describe the development of two effective downstream processes for purification of adenovirus from cell culture harvest.