Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q: My company is a contract manufacturer. Our final product inspection process consistently delays timely release of the manufactured products to our clients. Is there a best process/practice for performing final
product inspection?

A: This is not a new problem for the industry. To me, some of the issue is the fact that we call the specific activity of the overall physical product evaluation the “final product inspection.” In my opinion, the physical product evaluation should start at the beginning: the receipt of the individual components (stoppers, vials, labels, etc.) that are used in manufacturing. Each component should pass an incoming quality inspection with defined acceptable quality limits (AQL) and clear directions for rejection of the component should it exceed the AQL. The specific elements to be looked at on incoming inspection will vary depending on the component.

Let’s assume your company manufactures sterile injectable products and the major component you will use in manufacturing is a glass vial. The first step in the process is to perform an incoming inspection of the glass vials. The number of vials to inspect from the shipment will depend on the number of vials contained in the shipment. The sample size to be inspected should be recorded in the appropriate standard operating procedure (SOP). The specific defects to be inspected should also be included in the SOP. When evaluating these defects, most companies employ definitions of critical, major, and minor to the reject/accept criteria. In the case of vials, critical might be defined as likely to cause harm to the patient; major might be defined as leads to impairment to the patient; and minor would be defined as cosmetic defect causing no threat to the patient. Defining the acceptance criteria upfront may save you a lot of time at the end of the process.

Once the vial is accepted, it will be used in the manufacturing process. Defects that exist in the vial after initial acceptance may be detected during this step of the process. Many manufacturing lines have automatic sensors that detect vial imperfections and eliminate the vial from the batch before it is sent for labeling. It is important for the line operators to be trained to recognize when there is an increase in rejected vials because this could mean that the incoming inspection did not pick up the vial defect. Again, if the defect can be detected and categorized at this process stage, it will save time at the product release stage.

The last stage for potential vial inspection before labeling would be visual inspection of the stoppered vial. Some companies perform this step manually with trained visual inspectors while others utilize visual inspection equipment to perform the final inspection of the vial before labeling. Companies using vial inspectors typically focus those inspectors on looking for particulates in the vial, but they should also be trained to recognize vial defects. Regardless of which inspection format is used, there should be SOPs and AQLs governing the inspection process.

Final product inspection results should be included as part of your batch release documentation, so it is important to have repeatable, defined process/processes in place at all stages of the manufacturing process that is/are suitable for the product being inspected. The more time you spend upfront in the component inspection process, the more efficient your final inspection and batch release process will be to ensure timely product release to your clients.

Susan J. Schniepp is distinguished fellow at Nelson Laboratories, LLC.

When referring to this article, please cite it as Schniepp, S. Final Product Inspection: Making the Most of Your Processes. 

Articles

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Final Product Inspection: Making the Most of Your Processes

Charles Ross & Son Company's 42N-18SS Ribbon Blender

ROSS’ Ribbon Blenders are designed to handle a wide range of dry materials, from seasonings and beverage mixes to pharmaceuticals, chemicals, plastics, and agricultural powders or granules. These blenders also incorporate minor liquid components to effectively coat individual solid particles. They are manufactured with long-term performance and quality in mind.

The pictured ROSS Model 42N-18SS is crafted from type 316 stainless steel with interior surfaces polished to a 150-grit finish. With a maximum working capacity of 18 ft³, the blender is direct-driven by a 10-horsepower gearmotor for processing materials with a bulk density of up to 60 lbs/ft³.

The agitator is a solid double ribbon design, designed for center discharge, with internal flanges welded to shaft stub ends and a heavy-duty anti-friction bearing on the non-driven end. The blender includes a two-piece safety grating with half-inch diameter perforations for safe operation while the split folding covers are open. A spray bar with fan-type spray nozzles is installed on the trough via sanitary tri-clamp connections for liquid additions. The blender is operated from a four-inch color touchscreen that includes a cycle timer, start/stop, forward/reverse, and speed controls. The finished product is discharged through a pneumatically operated four-inch dust-tight knife gate valve.

ROSS’ Ribbon Blenders are designed to handle a wide range of dry materials and effectively coat individual solid particles, keeping long-term performance and quality in mind.

Ribbon Blenders

Suncombe’s IsolatorCIP Automatic Cleaning System

Suncombe’s IsolatorCIP automatic cleaning systems provide aqueous, detergent, and/or solvent cleaning of glovebox isolators. IsolatorCIP uses a clean-in-place (CIP) system to reduce the possibility of cross-contamination after each use and remove any product or debris. This design allows for repeatable cleaning of isolators and gloveboxes without a breach of the isolator in the process. The cleaning sequence can be configured to include different water qualities, chemicals, detergents, and sterile hot, cold, and dry air streams. These can be provided at accurately controlled temperatures, flowrates, and pressures.

Using variable recipe-derived configurations, the IsolatorCIP can also be used to clean additional processing equipment enclosed inside the isolator or be fitted onto the in-feed or discharge sides. Incorporating replaceable modules, the base unit is a fully hygienic version, with optional modules for sterile use, including sanitizing and sterilizing configurations.

Suncombe’s IsolatorCIP systems can be integrated with isolators of any manufacturer. With pre-configured mechanical and control interfaces, they minimize the potential for cross contamination and downtime while also ensuring the protection of personnel. The machines are manufactured from type 316 certified stainless steel, and use an easily configured recipe structure, providing confirmation at the successful completion of cycle. Remote control facilities can be incorporated for interfacing with the isolator’s control systems.

Suncombe’s IsolatorCIP automatic cleaning systems provide aqueous, detergent, and/or solvent cleaning of glovebox isolators. 

Automatic Cleaning System

Feliza Mirasol is the science editor for 

Novo Nordisk announced on Nov. 23, 2023 that it will invest more than DKK 16 billion (US$2.3 billion), starting in 2023, to expand its existing production site in Chartres, France. The company plans to significantly increase the capacity of the manufacturing site by adding aseptic production and finished production processes, as well as an extension of the site’s current laboratory for quality control.

With the expanded facilities, the site’s footprint will be more than doubled. The investment includes capacity for glucagon-like peptide-1 products, according to a company press release. Construction projects for the expansion have been initiated and will gradually be finalized between 2026 and 2028. More than 500 new jobs are expected to be created, and production activities are expected to run 24/7 upon completion of construction.

“This significant investment announced today confirms the importance of our French manufacturing site, one of our strategic production sites, as a cornerstone of the growth we are experiencing as a company. By maximizing the skills and infrastructure we already have on the site, we are expanding our capacity in an efficient way,” said Lone Charlotte Larsen, corporate vice-president of Novo Nordisk Production Chartres, in the press release.

“Our continued investments in our manufacturing sites across the globe demonstrate the belief we have in our current and future product portfolio and its relevance for people living with serious chronic diseases,” said Henrik Wulff, executive vice-president, Product Supply, Quality & IT, Novo Nordisk, in the release.

Novo Nordisk will invest more than DKK 16 billion (US$2.3 billion) to expand its production facilities in Chartres, France.

Novo Nordisk to Make Multi-Billion Dollar Investment in Expansion of Production Facilities in France

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

In sickle cell anemia mishappen and sticky hemoglobin cells cannot carry oxygen properly and frequently clump, clogging blood vessels and sometimes causing searing pain termed a vaso-occlusive crisis. It is debilitating. β-thalassemia isn’t etiologically closely related, however, similar to sickle cell disease (SCD), genetic defects are passed on from both parents, which leads to low hemoglobin production. This creates fatigue, jaundice, shortness of breath and irregular heartbeats. A fresh (Nobel prize winning) tool to redress both mutational situations was recently given Medicines and Healthcare products Regulatory Agency (MHRA) approval, in a world-first approval for complicated next-generation therapeutics (

). Clustered regularly interspaced short palindromic repeats (CRISPR) was successfully applied to both disease states, in a therapeutic called Casgevy (exagamglogene autotemcel, or exa-cel).

CRISPR is so new that this MHRA approval caused quite a stir in both the medical and pharmaceutical worlds. Even at the end of November 2023 the American society of Hematology didn’t appear to convey much about this news, nor the attendant questions and issues that must still be addressed. These include potential immunogenicity because of biology outside of the CRISPR itself, and also access alongside cost and reimbursement.

Casgevy galvanizesproduction of a form of hemoglobin normally made only in developing fetuses. “Production of this fetal hemoglobin is typically shut off soon after birth by a gene called 

, allowing fetal-hemoglobin production to resume. This provides some hemoglobin that is not misshapen and dampens the effects of the abnormal form. Vertex and CRISPR Therapeutics reported that, at nine months after treatment, 31 of 32 participants in their clinical trial had not had a single vaso occlusive crisis. Before treatment, they’d had an average of about four each year” (2).

CRISPR remains somewhat controversial for potential off-target effects. On top of this, after it makes its cut in the DNA of the 

 gene, CRISPR relies on the cell’s natural DNA repair machinery to stitch the strands back together. The step can introduce new errors. All of this is well known and becoming better understood; however, in its advisory committee briefing, Vertex stated: “There is no known or hypothesized mechanism whereby a DNA edit would revert to reduce the reactivation offetal hemoglobin (HbF) after exa-cel treatment. The long-term engraftment of edited cells also demonstrates the successful editing of long-term hematopoietic stem cell (HSCs) that are known to persist for a person’s lifetime” (3).

What is potentially equally worrisome for Casgevy are new findings from Wellcome Sanger Institute, University of York, and Boston Children’s Hospitalscientists outlining an observation that “cell competition” following gene therapy, may increase leukemia incidence. “The cause is likely not the gene therapy treatment itself, say researchers, but the therapy process, which involves gene editing outside the body and re-transplantation of stem cells back into the patient.” The authors go on to say “Instead, the process of genetically modifying these stem cells outside the body and re-transplanting them back into the patient makes blood stem cells that already have these mutations more prominent, thereby increasing their influence on the blood and immune systems.” The authors hypothesize younger patients might be an easier cohort to manage these therapies through, as their stem cells inherent have fewer mutations to “select” as triggering undesirable outcomes, and that “Continuously tracking these mutations and gaining a deeper understanding of these processes will profoundly impact the future well-being of sickle cell patients around the world.” (4)

While they are approximately 100,000 SCD patients in the United States, the disease seems related to malaria, and hence the vast majority of sufferers live in resource-poor nations. Vertex Pharmaceuticals said it had not yet established a price for the treatment in Britain and was working with health authorities “to secure reimbursement and access for eligible patients as quickly as possible. In the US, Vertex has not released a potential price for the therapy, but a report by the nonprofit Institute for Clinical and Economic Review said prices up to around $2 million would be cost-effective. By comparison, research earlier this year, showed medical expenses for current sickle cell treatments, from birth to age 65, add up to about $1.6 million for women and $1.7 million for men.” (5)

Not only cost but access to the “manufacture” of this treatment is also a barrier to widespread implementation. “In the US, there are approximately 200 specialized centers for bone marrow transplants. There are only three such centers for all of sub-Saharan Africa—in Nigeria, Tanzania, and South Africa. Making these types of CRISPR-based therapies available throughout the continent will require massive investment in clinical infrastructure. The road from now, having gene editing that is possible and implemented where most people live, it’s not that close,” said Ambroise Wonkam, a geneticist at Johns Hopkins School of Medicine and the University of Cape Town who also serves as president of the African Society of Human Genetics. “We have to put that into perspective” (6).

Casgevy was used here as synecdochic for the surging tidal wave of new modalities. The choice might well have fallen to ARCT-154, a self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older, which was even more recently given approval by Japan's Ministry of Health, Labor and Welfare (MHLW). While ARCT-154 was tested on 16,000 patients compared to Casgevy in 40 patients only, and. while the cost and access is no barrier compared with Casgevy, both therapeutics herald new ways of thinking, new types of testing and validation, and new types of manufacture and end-point monitoring. Following on from the revolutionary COVID-19 vaccines, what comes next is more complicated, more difficult to price for reimbursement, and more effective in terms of cure rates. The toothpaste is out of the tube, and the industry must learn to adapt to take best advantage of what is becoming available, no matter how messy the process.

1. MHRA. MHRA Authorizes World-First Gene Therapy that Aims to Cure Sickle-Cell Disease and Transfusion-Dependent β-thalassemia. Press Release, Nov. 16, 2023
2. Ledford, H. Is CRISPR Safe? Genome Editing Gets Its First FDA Scrutiny. 

 (7986), 234–235. DOI: 10.1038/d41586-023-03317-7
3. FDA. 

Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement

, Oct. 31, 2023.
4. Wellcome Sanger Institute. New Research Sheds Light on Cancer Risk in Gene Therapies. 

, Nov. 16, 2023.
5. Cheng, M. The World’s First Gene Therapy for Sickle Cell Disease Has Been Approved in Britain. 

, Nov. 16, 2023.
6. Molteni, M. With CRISPR Cures on Horizon, Sickle Cell Patients Ask Hard Questions about Who Can Access Them

Chris Spivey is the editorial director for 

Exagamglogene autotemcel seen as synechdoche.

New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia

TAU Systems, a US-based producer of compact laser-driven plasma accelerators and light sources, announced on Nov. 21, 2023 that it has signed a lease for a state-of-the-art building in Carlsbad, Calif., in which it will establish TAU Labs. The facility will be the first of the company’s light source applications and R&D centers, which will give users easier access to the latest particle and imaging systems. The first phase of construction is expected to be complete in 2024, according to a company press release.

The company is developing compact particle accelerators and specialized X-ray sources that combine the capabilities of large accelerators with a small footprint. This design is meant to provide easy and affordable beam-time access for any company or research institute, and, by doing so, the facility democratizes accelerator access, allowing for the progress of semiconductors, space-bound electronics, battery technology, biotechnology, and nuclear energy, among other industries, according to the press release.

TAU Systems' particle and light sources comprise the electromagnetic spectrum—from ultraviolet (UV) to gamma wavelengths—and will be installed in a 22,300-ft

 building located at the Carlsbad Research Center. The lab space will house several laser-driven particle and light sources as well as broad technical expertise. Industrial users will have wide access to extreme UV and X-ray light sources as well as million electron volt electrons and other particle beams.

"Laser-driven particle accelerators are incredibly powerful tools that enable unprecedented advances in a wide range of fields, from next-generation semiconductors and batteries, and custom-designed medicines to the advancement of fundamental physics. However, getting beam time on the very few facilities available globally is stifling progress,” said Bjorn Manuel Hegelich, CEO, TAU Systems, in the press release. “TAU's application centers will democratize access to these exciting machines and expedite crucial technological breakthroughs."

"Our high-repetition-rate laser driver also makes TAU Labs an ideal location to test the resistance to space radiation of satellite electronics. It will help make space systems more robust and prolong the life of satellites," said Jerome Paye, chief operating officer, TAU Systems, in the press release.

TAU Systems plans to establish TAU Labs, a new next-generation, laser-driven plasma accelerator laboratory, in Carlsbad, Calif.

TAU Systems to Establish TAU Labs, a New Laser Plasma Accelerator Application Center

On Nov. 21, 2023, Genentech, a member of the Roche Group, announced that it has entered into a multi-year strategic research collaboration with NVIDIA, a US-based computing company. The companies plan to combine Genentech’s artificial intelligence (AI) capabilities, extensive biological and molecular datasets, and research expertise with NVIDIA’s accelerated computing capabilities and AI to speed up drug discovery and development.

The collaboration is meant to significantly enhance Genentech’s advanced AI research programs by turning the company’s generative AI models and algorithms into a next-generation AI platform, which would be designed to expedite the discovery and delivery of novel therapies. Under the agreement, the companies aim to accelerate and optimize Genentech’s proprietary machine learning algorithms and models on the NVIDIA DGX Cloud. The cloud provides a training-as-a-service platform that has been built on dedicated NVIDIA AI supercomputing and software, including NVIDIA BioNemo for generative AI applications in drug discovery.

Also under the agreement, NVIDIA will share its computing expertise with Genentech’s teams of computational scientists, under which Genentech’s models will be optimized and scaled. This process may also improve or enhance NVIDIA’s platforms.

The collaboration will also help accelerate Genentech’s “lab in a loop”, in which extensive experimental data will feed computational models to uncover patterns and make new, experimentally testable predictions. Scientists can then quickly assess these predictions in the lab, and the results are fed back into the models to improve the underlying computational model. This loop is expected to allow for the iterative development of better therapies, according to a company press release.

“By harnessing the power of AI models and algorithms with our unique data and experiments, we're unlocking scientific discoveries with incredible speed and generating insights at an unprecedented scale,” said Aviv Regev, executive vice-president and head of Genentech Research and Early Development (gRED), in the press release. “Bringing science and technology together has always been a foundation of biomedical breakthroughs at Genentech. We are thrilled to join forces with NVIDIA to further optimize our drug discovery and development to deliver treatments that transform people’s lives.”

“The greatest impact of generative AI is to revolutionize the life science and healthcare industry,” said Jensen Huang, founder and CEO of NVIDIA, in the release. “Our collaboration to create Genentech’s next-generation AI platform will dramatically accelerate the pace of drug discovery and development.”

Under this multi-year collaboration, Genentech and NVIDIA will use AI to optimize and accelerate each company’s platforms to discover and develop innovative therapeutics.

Genentech and NVIDIA Form AI Research Collaboration for Drug Discovery and Development

PTE discusses mRNA advances with Guillaume Roelandts, Head of Products and Marketing, Quantoom Biosciences, at the 11th International mRNA Health Conference.

Tackling Production Challenges through Greater Access to mRNA Technologies

, discusses messenger RNA (mRNA) advances with Guillaume Roelandts, Head of Products and Marketing, Quantoom Biosciences, at the 11th International mRNA Health Conference in Berlin, Germany. Quantoom Biosciences is a team of scientists, engineers, and clinicians committed to solving some of the biggest DNA and RNA production challenges facing vaccines and therapeutics by delivering greater access and autonomy to mRNA technology. This discussion introduces the company’s background and explores its future direction. It also covers Quantoom’s expertise in process development for mRNA synthesis and purification, and the process of validating a GMP cleanroom machine with regulators.

Quantoom Biosciences is part of Univercells, a global life sciences group with the mission of making biologics accessible to all. Launched early in the pandemic in June 2021, Quantoom entered into a strategic collaboration with eTheRNA to build an advanced, small footprint technology platform for the production of affordable RNA-based therapies. The platform can be used within existing facilities or rapidly deployed to areas of urgent need.

Milestones in Quantoom’s development include a grant from the Bill and Melinda Gates foundation and the acquisition of SynHelix, which developed a technology that, with the use of bacteria, is an alternative to DNA amplification. SynHelix, later renamed Quantoom Research France, is focusing on integrating a “new generation DNA bioreactor” that could provide great benefits in productivity and cost reduction, both for R&D and production needs. The World Health Organization (WHO) interest in Quantoom, through their tech transfer program, has led to mRNA production facilities and BioPharm technologies being placed in several emerging countries.

Chris Spivey, editorial director for Pharmaceutical Technology, discusses messenger RNA (mRNA) advances with Guillaume Roelandts, Head of Products and Marketing, Quantoom Biosciences, at the 11th International mRNA Health Conference in Berlin, Germany.

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced on Nov. 21, 2023 that it has opened the second phase of its new €29 million (US$43 million) Biologics Testing Center in Shanghai, China, which opened in 2022. The expansion includes an added 1500 m2 of lab space, which are the first biosafety laboratories for the company in the Chinese market. This expansion enables the company to serve local clients, according to a company press release.

The new lab space offers testing services for cell line characterization and lot release from pre-clinical development to commercialization. MilliporeSigma can now offer biosafety testing services for monoclonal antibodies, other recombinant proteins, and cell and gene therapies to the local market.

The first phase of the new testing center allowed the company to provide testing services for viral clearance studies, while the second phase adds capabilities for cell line characterization to help ensure the safety, purity, and identity of cell banks. The testing center also offers current good manufacturing practice-compliant lot release testing for unprocessed and purified bulk harvest for meeting the requirements for biologics that are entering preclinical and clinical studies and for licensed biologics.

“The opening of the facility deepens our partnership with our Chinese clients who are at the forefront of shaping modern medicine,” said Dirk Lange, head of Life Science Services, Life Science business sector of Merck KGaA, Darmstadt, Germany, in the press release. “The Biologics Testing Center in Shanghai now provides critical local services backed by our more than 75 years of global experience in the testing market.”

MilliporeSigma has expanded its biosafety testing laboratories in Shanghai, China, with the completion of new lab space at its new €29 million (US$43 million) Biologics Testing Center.

MilliporeSigma Expands Biologics Testing Center in China

 spoke with LIGHTHOUSE Instruments regarding the company's new products for robust headspace data generation. Learn more about:

How LIGHTHOUSE Instruments supports customers to generate science-based product and process data.

In which application areas laser-based headspace analysis is the preferred method over traditional methods used in the pharmaceutical industry.

An introduction to new headspace platforms for efficient robust data generation.

Video interview with LIGHTHOUSE Instruments

LIGHTHOUSE Instruments Launches New Products for Robust Headspace Data Generation at the CPHI in Barcelona

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LIGHTHOUSE Instruments introduces new technology for robust headspace data generation and areas of application.

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach