Pharmatech Associates articles: technical expertise for the regulated life science industry
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Process Validation & Defining What Is Critical

Bikash Chatterjee discusses the importance of linking process design to product performance, and defining critical process parameters.
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Breaking Through FDA’s New “Accelerated” Pathway

Breaking Through FDA’s New “Accelerated” Pathway | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

Industry specialist Kerri-Anne Mallet of Pharmatech Associates writes about maneuvering through FDA's accelerated pathway.

Judy Curtis / SIPR's insight:

A new article in MD +DI from Pharmatech Associates' Kerri-Anne Mallet discusses CDRH's proposed Innovation Pathway. This is a priority review program to help breakthrough medical devices reach patients in a timely manner by improving collaboration between FDA and manufacturers and shorten the time and reduce the costs from concept to commercialization for innovative medical devices.

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Technical Transfer to CDMO – Case Study Best Practices for Success | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services

Technical Transfer to CDMO – Case Study Best Practices for Success | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

Technical transfer to a contract development and manufacturing organization (CDMO) mobilizes the efforts of a technical team, from start through commercialization activities and throughout the life cycle of a product.

Judy Curtis / SIPR's insight:

Sandra Wassink demonstrates that success in manufacturing at the CDMO is reliant on full disclosure of early development history, collaborative fine-tuning of critical attributes through Phase III and continued teamwork into commercial manufacturing. In turn, the flexibility, experience and professionalism of both companies is required to achieve safe, consistent, and quality product commercialization.

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Considerations for Biologic Drug Substance and Drug Product Testing, by Bikash Chatterjee

Considerations for Biologic Drug Substance and Drug Product Testing, by Bikash Chatterjee | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

Chief Editor’s Note: An Outsourced Pharma reader wondered about the handling of incoming bulk drug substance, leading to this feature article by Bikash Chatterjee, of Pharmatech Associates.

Judy Curtis / SIPR's insight:

Biologic drug development consists of two fundamental components: the drug substance (DS) development, which can include the master and working cell bank development, manufacturing process development, and scale-up; and the drug product (DP) development, which includes the filling of the drug substance into the primary container.

 

Today’s CMO or contract testing lab is charged with executing critical development activities but will also provide insight based upon their own experiences with multiple processes.

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The Value Of Standardizing Risk Assessment Across Quality Systems - by Moria Feighery-Ross, Pharmatech Associates

The Value Of Standardizing Risk Assessment Across Quality Systems - by Moria Feighery-Ross, Pharmatech Associates | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
Development, validation, regulatory approval, compliance, and continuous improvement are all features of the overall process of manufacturing and releasing product that can be enhanced by proper use of risk assessment.
Judy Curtis / SIPR's insight:

In Pharmaceutical Online, Moria Feighery-Ross of Pharmatech Associates discusses risk management. Development, validation, regulatory approval, compliance, and continuous improvement are all features of the overall process of manufacturing and releasing product that can be enhanced by proper use of risk assessment.

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12.16.17 -- Top 10 Of 2017

12/16/17 Pharmaceutical Online Newsletter


In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

Judy Curtis / SIPR's insight:
Rounding off the year 2017, Bikash Chatterjee's two-part article on the FDA's New Quality Agreement Guidance is among the top 10 most popular articles published this year in the Pharmaceutical Online newsletter.

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Findings from part iii of the CPhI Annual Report announced by UBM - “Prospects, Analysis, and Trends in Global Pharma"

Findings from part iii of the CPhI Annual Report announced by UBM - “Prospects, Analysis, and Trends in Global Pharma" | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
The findings from the final section (part iii) of the CPhI Annual Report have been announced by event organisers UBM.
Judy Curtis / SIPR's insight:
Bikash Chatterjee, president and chief science officer of Pharmatech Associates, argued that the emergence of a global marketplace with shared regulatory compliance is one of many factors driving change in pharmaceutical regulation.
Key to this is the adoption of the PIC/S by 50 regulatory entities, he revealed, as well as other important legislation changes that have been introduced, such as the 21st Century Cures Act.

Chatterjee highlighted the increasing role of data in illustrating performance and compliance and stressed that improvements in big data analytics will be crucial in identifying the most suitable candidate drugs more quickly from e-clinical, lifestyle diagnostics and digital health initiatives.


However, he also emphasized cyber-security as a potential risk factor, especially as the industry increases dependence on patient data for drug development. “The industry’s ability to manage the constantly evolving threats to data management and integrity will define how we develop new drug therapies in the future,” he explained.
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How Should I Respond To This FDA Warning Letter (And Other Compliance Questions Answered)

How Should I Respond To This FDA Warning Letter (And Other Compliance Questions Answered) | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today's complex global regulatory environment.

Judy Curtis / SIPR's insight:
Richard Aleman, VP of regulatory compliance at Pharmatech Associates, has an insider’s view on global regulatory issues having spent almost three decades at the FDA, specializing in biopharmaceuticals, drugs, and medical devices.

He answers some important questions about warning letter responses and remediation  and other important regulatory issues — in a guest column published in Pharmaceutical Online, in September 2017. 

Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action.  
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Process Design Risk Management — A Proactive Approach

Process Design Risk Management — A Proactive Approach | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

"The FDA has given us the green light to assess and manage risk earlier in the drug development cycle."

Judy Curtis / SIPR's insight:
The latest article by Sandra Wassink of Pharmatech Associates in Pharmaceutical Online discusses a strategy to implement risk management during the process design stage of process validation for quality product, and to use as a proactive means of addressing quality controls during the subsequent stages of development. Managing risk from the outset helps prioritize what efforts need to be made during process design.
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Electronic Transfer of Regulatory Information

Regulatory Forum column, by Bikash Chatterjee in May/June 2017 issue of Controlled Environments magazine.

As the deadline looms for drug master files, the FDA moves toward e-filing.
Judy Curtis / SIPR's insight:
The FDA is moving toward electronic filing because electronic documents greatly simplify the update, receipt, processing, and evaluation process within the agency.
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4 Key Considerations When Engaging A New GMP Contract Service Provider

4 Key Considerations When Engaging A New GMP Contract Service Provider | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

Integrating a contract service provider (CSP) as part of a supply chain to bring a product to market is a critical decision that impacts many aspects of bringing a pharmaceutical product to market, safely and effectively.

Judy Curtis / SIPR's insight:
This article by Bikash Chatterjee of Pharmatech Associates explores what is important when establishing an effective relationship with a contract service provider as the drug development program moves from product and process design to commercial manufacturing.
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FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)

FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say) | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. 

Judy Curtis / SIPR's insight:
The new guidance highlights the need to define who is responsible for facility and equipment activities that impact manufacturing operations. This includes defining who will handle facility and equipment qualification and process validation. It also should extend to systems that support the manufacturing operation, including information technology and automated control systems, environmental monitoring and room classification, utilities, and any other equipment and facilities that must be maintained to perform the contracted manufacturing operations in compliance with cGMP. 

 However, it would have been beneficial for the agency to also provide some insight as to how a drug sponsor should handle facility and equipment changes after commercial introduction. Establishing a practical and manageable process that will clearly define when and how the drug sponsor will be notified of material changes to the facility and equipment would minimize unexpected excursions downstream. In addition, clearly understanding how the CMO will administer continuous monitoring for Stage 3 process validation is a good framework for the discussion.
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FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)

FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say) | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. 

Judy Curtis / SIPR's insight:
As CMOs assume a much greater share of the development responsibility — evolving into CDMOs — many questions have been raised regarding the content and timing of quality agreements. In fact, the very merit of highly tailored quality agreements has been a point of debate. Let’s examine the new FDA guidance with this backdrop in mind. This is the first part of a two-part article by Bikash Chatterjee of Pharmatech Associates.
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Back to the future? The resurgence of combination drug products

Back to the future? The resurgence of combination drug products | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.
Judy Curtis / SIPR's insight:

Reporter Flora Southey spoke with Lynn Hansen and Bikash Chatterjee in the lead-up to Pharmatech Associates' tutorial at DIA 2018 Global Annual Meeting in Boston, to discuss regulatory approval processes, manufacturing challenges, and the resurgence of the combination drug product in the 21st century.

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FDA’s Draft Guidance of “Least Burdensome Provisions” for Medical Devices

FDA’s Draft Guidance of “Least Burdensome Provisions” for Medical Devices | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

"While this new guidance brings greater clarity and simplicity in device submissions, the success of this new philosophy will be greatly dependent upon sponsors’ ability to effectively lead and collaborate with the FDA to confirm alternative solutions that can address the agency’s regulatory questions," said Bikash Chatterjee of Pharmatech Associates.

Judy Curtis / SIPR's insight:

New draft guidance defines the seven guiding principles to be followed by both FDA and the medical device industry when taking a least burdensome approach to a regulatory issue, discussed in the latest Regulatory Forum column by Bikash Chatterjee, in Controlled Environments magazine. 

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Raw Materials and Functional Excipients | American Pharmaceutical Review

Raw Materials and Functional Excipients | American Pharmaceutical Review | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
A small variation in the impurity profile, viscosity, particle size, dissolution characteristics, molecular weight etc. of an excipient could have drastic impact on the end performance of a pharmaceutical formulation or process.
Judy Curtis / SIPR's insight:

How have advances in raw materials functionality, supply and quality affected the pharm/biopharma industry? Sandra Wassink and Bikash Chatterjee of Pharmatech Associates weigh in on the topic, in an industry roundtable published in American Pharmaceutical Review

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The Right Stuff: Making the Transition from Development to Commercial Manufacturing with Your CMO | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services

The Right Stuff: Making the Transition from Development to Commercial Manufacturing with Your CMO | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

CMO Commercial Transition Focus Areas

Judy Curtis / SIPR's insight:

In an article published in Pharmaceutical Outsourcing, Bikash Chatterjee of Pharmatech Associates uses a recent case study to illustrate specific areas at risk that can impact a drug sponsor’s regulatory risk profile and on-going commercial operations as a drug sponsor’s development program transitions to commercial launch.

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FDA Updates Guidance on Electronic Records, Signatures

FDA Updates Guidance on Electronic Records, Signatures | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
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Judy Curtis / SIPR's insight:
What to expect from FDA’s updated guidance on use of electronic records & electronic signatures in clinical investigations under Part 11. Regulatory Forum column by Bikash Chatterjee of Pharmatech Associates in Controlled Environments magazine, Jan-Feb 2018.
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Pharma 4.0: A New Framework & Process For Digital Quality Management

Pharma 4.0: A New Framework & Process For Digital Quality Management | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
From a starting point of industry risk-aversion, the regulators have empowered manufacturers to keep evolving to combine industrial processes with new advanced analytics capability. The approach known as Pharma 4.0 represents a strategy for the future, derived from an intelligent and fully connected network across the entire value chain.
Judy Curtis / SIPR's insight:
A new article by Bikash Chatterjee of Pharmatech Associates  highlights how regulatory guidance and directives over the past decade have encouraged a new approach to pharma manufacturing, based on "compliance through science." 

"Pharma 4.0 is a term for the industry-specific global vision and initiative based on Industry 4.0. The idea behind Industry 4.0 is to develop the infrastructure and create standards that allow us to connect data, physical equipment, and human resources in the context of an overarching cyber-physical system. Of course, Pharma 4.0 promises to improve quality, productivity, and lead times through interconnectivity and automation, but the most dramatic potential is the ability to gather data beyond the four walls of the factory through the use of Internet of Things (IoT) and Big Data analytics."
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Pharmaceutical Engineering - Sept-Oct 2017 - 15

Pharmaceutical Engineering - Sept-Oct 2017 - 15 | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
Pharmaceutical Engineering is ISPE's bi-monthly technical magazine published for Members engaged in all aspects of R&D and manufacture of safe and effective medicines covering topics important to the global pharmaceutical industry across all sectors, including traditional pharma, biotech, innovator and generics. PE presents valuable information on the latest scientific and technical developments, regulatory initiatives and innovative solutions to real-life problems and challenges through practical application articles and case studies. Technical articles will demonstrate global best practices in engineering and design; product development; technology transfer; manufacturing process development and scale-up; commercial manufacturing; quality and compliance; and product lifecycle management.
Judy Curtis / SIPR's insight:
A Breakthrough for Industry and Patients - cover story - Pharmaceutical Engineering Sept-Oct 2017
Article by Scott Fotheringham, PhD

On 30 August 2017, The U.S. FDA approved Novartis' Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs called chimeric antigen receptor (CAR) T-cell therapies, which constitute a form of immunotherapy that essential takes control of the body's T-cells and directs them to attach tumors in patients with ALL. This is the first FDA-approved gene-transfer therapy among a number of CAR T-cell products that are in development. 

Among the experts interviewed for this story is Mihaela Simianu, PhD, Director of Regulatory Compliance at Pharmatech Associates, who spoke to the complexities of manufacturing CAR-T cell therapies, compared to biologics.

“For biologics, the active ingredient is a nonliving biological modality isolated or produced at large scale using biotechnological methods. In this case, living cells are genetically engineered and used to express at scale the desired active ingredient. With cellular therapy, the starting active ingredient and the product are living cells.” 

The complexities go beyond safety and manufacturing to include the need to maintain stability and chain of identity for product shipped from a medical center to the Novartis facility and back again. “Cell activity and other functional attributes are sensitive to time and conditions used during transit across locations and points in the process; expedited and controlled transit of these living cells is a critical success factor,” said Dr. Simianu. “For example, one may need to ensure that cells arrive at the manufacturing site within an 18- to 48-hour time frame. Specific containers, data loggers to keep track of samples, chain of custody, and carriers that can do this without a flaw are needed. All the details impacting cell-material stability during the closed-loop supply chain must built into the development of the product; it can’t be an afterthought.”


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Preparing for the New European Medical Device Regulations

Preparing for the New European Medical Device Regulations | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
The new MDR and IVDR are huge departures from the historical directives they are replacing. The changes do not grandfather programs and will become law across all EU member states at the end of the transition period. Currently approved products and new submissions must consider the implications of these new regulations now during the transition period to be ready to align their programs with these new regulations.
Judy Curtis / SIPR's insight:
While it may seem like a long time before the new European MDR and IVDR directives take effect - in 2020, and 2022, respectively - the changes in these new regulations are significant, and include greater traceability requirements and post-market clinical surveillance. Bikash Chatterjee's latest Regulatory Forum column in Controlled Environments outlines the points to watch.


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Phase-Appropriate Frameworks at the Intersection of CMC and cGMP Pathways

Phase-Appropriate Frameworks at the Intersection of CMC and cGMP Pathways - article by Mihaela Siminiau, Ph.D, Director of Regulatory Compliance at Pharmatech Associates.

Judy Curtis / SIPR's insight:
Mihaela Siminau of Pharmatech Associates' article in Pharmaceutical Outsourcing talks about how mapping information flow across multiple service providers requires a paradigm shift in organizational thinking. "There are benefits and also increased complexities caused by business outsourcing models in an industry characterized by a high diversity of therapeutic products and medical technologies. 

Industry continues to search for ways to simplify and streamline development activities while having to incorporate industry best-practice concepts such as quality by design (Qbd) and expectations set up by regulators worldwide. 

Phase-adapted development requires deployment of frameworks that bring clarity and simplification from the top of a QMS that drives value in execution for sponsors and service providers alike."
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More Bacon than the Pan Can Handle

More Bacon than the Pan Can Handle | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
What’s a pharma manufacturer to do with all this hot, sizzling data?
Judy Curtis / SIPR's insight:
“Whether motivated by the FDA’s shift toward a scientific, data-driven definition for quality or a need to innovate to survive and be competitive in the new world marketplace, there is no doubt the push for greater understanding has resulted in a renewed emphasis on the ability to acquire, verify and leverage the power of data,” wrote Pharmatech Associates’ Bikash Chatterjee in Pharmaceutical Manufacturing in October 2016. 
“Big data can be broken down into five primary dimensions that describe the challenge: Volume, Variety, Velocity, Veracity and Value. When any one of these characteristics is not controlled, this constitutes a big data problem. Smart data focuses on Veracity and Value and argues more does not necessarily equate with better.”
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Examining FDA’s New Quality Agreement Guidance

Examining FDA’s New Quality Agreement Guidance | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

The new FDA guidance is a simple one, providing best practices and high-level insight into the components of a quality agreement. T

Judy Curtis / SIPR's insight:
While the FDA has elected to limit the scope of the guidance to commercial programs, we will see that industry still requires clarification on responsibilities that occur for a commercialized product after it comes to market. This is part 2 of the article by Bikash Chatterjee of Pharmatech Associates on the FDA's new guidance on quality agreements, published in Life Science Leader.
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Understanding Annex 16 Changes for Qualified Persons and Batch Release

Understanding Annex 16 Changes for Qualified Persons and Batch Release | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it

In the U.S. and Europe, the approach to ensuring drug quality has many more similarities than differences. But one key difference has always been the additional responsibilities placed upon the role of a Qualified Person or QP in ensuring the quality of a drug product. The European Union (EU) recently put in place new legislation under Annex 16, broadening the role and accountability of the QP with regard to responsibilities for batch release. The new legislation reflects the European Medicines Agency’s (EMA) efforts to introduce new quality control strategies that address today’s complex global pharmaceutical supply chain which includes new technologies such as Process Analytical technology (PAT), Real Time Release Testing (RTRT), and the growing problem of falsified medicines. This new directive has been in development since 2011 and replaces the old Annex 16 in effect since 2002. The changes are extensive and went into law in April 2016.

Judy Curtis / SIPR's insight:
The role of the "qualified person" (QP) in ensuring the safety and efficacy of medicinal products has expanded with the issuance of the European Union's revised Annex 16 directive. This reflects efforts to introduce quality control strategies that work within what has become a complex global pharma supply chain.
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2016 Wrap-Up: Looking Ahead to 2017 and Beyond

2016 Wrap-Up: Looking Ahead to 2017 and Beyond | Pharmatech Associates articles: technical expertise for the regulated life science industry | Scoop.it
2016 Wrap-Up: Looking Ahead to 2017 and Beyond
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