Newsletter | March 10, 2020

03.10.20 -- 3 CMC Mistakes That Could Cost You Billions

 
Featured Editorial
3 CMC Mistakes That Could Cost You Billions
 
By Kevin Wall, principal consultant and owner, Cincero Consulting

The endgame for many small biotech startups is acquisition by Big Pharma. How should small biotech companies prepare their chemistry, manufacturing, and controls (CMC) documentation for due diligence review? What are the mile markers that measure how far product and process have developed? While the CMC section may not add zeros to the sales price, poorly documented development can remove them.

An Analysis Of The FDA’s Recently Issued Gene Therapy Guidances
By Kalah Auchincloss, Greenleaf Health

The FDA has finalized six draft guidance documents intended to serve as part of a modern, comprehensive framework for how the agency will help advance the field of gene therapy. At the same time, it issued a new draft guidance on determining “sameness” of gene therapy products for the purposes of orphan drug designation/exclusivity. This article highlights key changes made in each of the final guidances and also reviews the new draft guidance.

Industry Insights
4 Reasons Blow/Fill/Seal Technology Should Be Considered For Aseptic Filling
Article | By Andy Goll, Weiler Engineering, Inc.

Drug manufacturers seeking alternative methods for a safe and reliable approach to drug delivery should consider blow-fill-seal technology, as it offers several benefits over traditional glass packaging.

Viscous Products No Match For New Container Closure Integrity Technology
White Paper | By Oliver Stauffer, PTI Packaging and Inspection Systems

New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing. 

Pharma Production Tech Transfers: Reaping Rewards, Reducing Risks
White Paper | By Thomas Dax, Mirko Gabriele, and Paul Jorjorian, Thermo Fisher Scientific

Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy
White Paper | By Jianzhong Hu, YZY biopharma

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

UniVessel Single-Use Bioreactor For CHO Fed-Batch Cultures
Application Note | By Adiba Zanghi, Debora Lin, Tina Balsara, Lucian Young, Barry Wolf, and Ping Huang, Sartorius Stedim Biotech

How single-use (SU) bioreactors reduce turnaround time and labor required for cleaning and autoclaving traditional glass vessels and minimize associated costs for maintenance and repair. 

Pharmaceutical Manufacturer Leverages Data And Analytics To Support New Continuous Drug Manufacturing Processes
Case Study | By Janice Abel, Seeq Corporation

This pharmaceutical manufacturer’s goal was to minimize the traditional scale-up challenges when moving from pilot production to commercial manufacturing. Read how they are utilizing the OSIsoft PI System data infrastructure and piloting Seeq’s analytics to optimize its product and processes to support continuous manufacturing.

Automated Endotoxin Testing Reduces Errors And Review Time
Case Study | By Scott Kaszuba, Pfizer

Pharmaceutical manufacturers are embracing automation and robotics, mainstays of other manufacturing fields, but can automation and robotics be brought into the QC lab as well?

A Complete Outsourcing Partner Has Expertise To Turn Ideas Into Reality
Article | B. Braun OEM Division

B. Braun’s OEM Division can help companies with packaging, sterilization, and regulatory compliance as an OEM partner. 

Particle Analysis Suite Facilitates Flexibility In Dynamic Laboratory Work Environment
Case Study | Flow Sciences Inc.

Flow Sciences is known for their flexibility and their unique reception of customer needs. When approached by a client with a specific design request, Flow Sciences was able to work with the client, including supplying a fiberboard mockup, so they could make additional considerations before finalizing the design, to come up with a solution.

Accessible Anywhere: How Pfizer Deployed The PI System To Enable Production Analysis Across The Organization
Case Study | OSIsoft

Pfizer’s Small Molecule Division’s operational data was siloed and only available within the physical building, in Groton, CT, increasing manual work, hindering collaboration, and creating data latency issues. To reach its goal of doubling the innovation success rate while decreasing time-to-market, Pfizer needed a new data strategy. Using OSIsoft’s PI System, Pfizer embarked on a journey to digitize the drug discovery process and create a single source of truth for self-service operational insights that are accessible anytime and anywhere.

Replace Dye Ingress With Mass Extraction To Mitigate Risks
Case Study | Pfeiffer Vacuum Inc.

A major pharma company had a problem. Its manufacturing process engineers could not reliably verify that pouch packages were sealed properly. Product could potentially ship with questionable packaging.

Specialized Drug Product Packaging Solutions
E-Book | Almac Group

Over the last decade the pharmaceutical industry has witnessed significant changes with regards to drug product packaging. With pharma companies developing and bringing more advanced medicines and niche orphan drugs to the market there has been a notable change in drug product packaging requirements. This e-book explores some of the biggest trends in the pharmaceutical packaging market, providing insight into key considerations for the various specialized packaging formats and the impact they could have on the drug product supply chain.

Beyond HPLCs: Advanced Analytical Tools For The Development And Analysis Of Drug Products
Webinar | Catalent

Gain insight into analytical techniques that reveal answers during product development, with an emphasis on Raman spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, and mass spectrometry (MS).

Solutions
Advanced Granulation Technology (AGT) Cell Culture
Thermo Fisher Scientific
Lipid-Based Formulations
Capsugel® | Lonza Pharma & Biotech
Your Trusted Packaging And Serialization Partner
Ropack Pharma Solutions
Thermo Scientific Global VersaWeigh Pharmaceutical Checkweigher
Thermo Scientific Product Inspection
Single-Station Hydraulic Pharmaceutical Tablet Press: NP-P20A Brochure
Natoli Engineering Company, Inc.
Events
Cannabis Company Equipment Auction

Online | March 30 to April 2, 2020

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