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Pharmaceutical Technology, July 2021 Issue
Complex Biomolecules Require Analytical Evolution
July 03, 2021
Cover Story
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7
The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.
Meeting Future Analytical Requirements for Novel Biotherapeutics
July 03, 2021
Cover Story
45
7
The future pipeline of complex novel biotherapeutics will require new approaches to analytical assessment.
Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene Hydrochloride
July 03, 2021
Peer Reviewed
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7
The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.
Subunit Vaccines and the Fight Against COVID-19
July 03, 2021
Development
45
7
Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.
Formulating Tablets Layer by Layer
July 03, 2021
Development
45
7
Bi-layer tablets are an under-utilized option that can be employed to help reduce treatment burden, but their formulation is more complex than for conventional monolayer products.
Spray Drying as an Enabling Technology for Inhalation Drug Delivery
July 03, 2021
Manufacturing
45
7
Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.
Innovations Meet Growing Demand for Prefilled Syringes
July 03, 2021
Manufacturing
45
7
Container and equipment innovations expand applications.
Survey of QPs on Remote Certification
July 02, 2021
Quality/Regulations
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7
Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.
Assessing Legacy Drug Quality
July 02, 2021
Quality/Regulations
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7
A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
Considering Annex 1 Revisions: Expert Insights
July 02, 2021
Quality/Regulations
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7
The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.
Balancing Pressing Priorities
July 02, 2021
Outsourcing
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7
CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.
White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines
July 02, 2021
Regulatory Watch
45
7
HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.
Avoiding Delays on the Road to Normalcy
July 02, 2021
From The Editor
45
7
Vaccines define the path to putting the pandemic in the rear-view mirror.
Identifying Promising COVID-19 Therapies
July 02, 2021
From The Editor
45
7
Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.
The Value of FDA 483s and Warning Letters
July 02, 2021
Ask the Expert
45
7
Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.
Die Table Segment Cleaning Equipment
July 02, 2021
Product Spotlight
45
7
Die table segment cleaning equipment features a fixture that holds the segment within the tank and leaves the bores unobstructed.
Airborne Particle Counter
July 02, 2021
Product Spotlight
45
7
The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.
Single-Stage Clarification
July 02, 2021
Product Spotlight
45
7
The 3M Harvest RC clarifier condenses three process steps into a single-stage purification of recombinant protein therapeutics.
Ergonomic Sanitary Ribbon Blenders
July 02, 2021
Product Spotlight
45
7
ROSS’ Sanitary Ribbon Blenders allow operators to safely empty bags of powder through a bar grating while a contiguous vibrating tray assembly catches debris and off-spec ingredients.