Roots Analysis

AUGUST 30, 2023

In 2022, a milestone was witnessed when the number of approvals received by biologics narrowly outpaced those reported by small molecules. This can be attributed to the fact that the demand for biologics has been constantly increasing and is supported by continuous innovation in this field.

40

40

The FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

Dosage 45

Dosage FDA 45

Roots Analysis

AUGUST 15, 2023

These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. Although such systems are still plagued with various challenges, these systems continue to improve at a rapid pace.

Vaccines 52

Vaccines 52

Pharmaceutical Technology

APRIL 5, 2023

It is also expected to help Caribou receive early and continual communication from the FDA during the regulatory review procedures. Topic sponsors are not involved in the creation of editorial content. The trial includes patients at dose level one. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

FDA 59

FDA Communication 59

Pharmaceutical Technology

MAY 5, 2023

Siegfried will leverage DiNAMIQS’ capabilities to commercial scale by constructing a facility that complies with good manufacturing practice standards. The move represents Siegfried’s strategy to expand its presence in biologics, and provides important growth opportunities in the mid to long term.

52

52

ISPE

APRIL 12, 2023

Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others. The continued use of paper validation in a Pharma 4.0 The continued use of paper validation in a Pharma 4.0

Documentation 98

Documentation FDA 98

Pharmaceutical Technology

JANUARY 20, 2023

The CEO illustrated his point, by discussing that in June, the Center for Biologics Evaluation and Research (CBER), at the FDA, requested new vaccines for the BA.5 Even though new variants continue to emerge, in September, the World Health Organization (WHO) declared that the end of the Covid-19 pandemic is “in sight”. said Bancel.

Vaccines 98

Vaccines Communication FDA 98

ISPE

NOVEMBER 3, 2022

There is also opportunity for regulators to continue to share information through convergence that may make it possible to provide new therapies on a more global basis. Director, Center for Biologics Evaluation and Research. He focused his remarks on manufacturing challenges. Peter Marks, MD, PhD. Convergence and More.

Communication 98

Communication FDA Documentation Vaccines 98

Pharmaceutical Technology

MAY 3, 2023

“A tenet of our continued innovation is a focus on accelerating the development of cell therapies as we strive to profoundly transform patient outcomes and, ultimately, progress potentially curative regimens.” Topic sponsors are not involved in the creation of editorial content.

FDA 59

FDA 59

Pharmaceutical Technology

APRIL 6, 2023

StrideBio’s Strive platform produced a library of candidates, using a structural engineering approach for generating novel AAV capsids to address the limitations generally faced by pharmaceutical companies focusing on AAV, including targeted biodistribution, pre-existing immunogenicity and manufacturability.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

APRIL 15, 2021

We have a pipeline of novel therapeutics and technological approaches, advancing a diverse array of candidates, including small molecules, biologics and cell and gene therapies, so a lot of the time we are working where there’s little, or no precedent.”. However, not all of these processes may be sustainable for the future. “If

Labelling 75

Labelling Communication FDA Pharmaceutical Companies 75

ISPE

MARCH 28, 2023

The pharmaceutical supply chain runs through the entire process of new drugs from innovation to clinical to approval. Summit host: Mr. Gao Xiaowei, Vice President/General Manager of Canton Biologics Mr. Zhang Ping, Chairman of the SPIC China Committee, Ms. Cao Yan from SPIC attended the conference online and delivered welcome speeches.

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 28, 2023

The pharmaceutical supply chain runs through the entire process of new drugs from innovation to clinical to approval. Summit host: Mr. Gao Xiaowei, Vice President/General Manager of Canton Biologics Mr. Zhang Ping, Chairman of the ISPE China Committee, Ms. Cao Yan from Shanghai ISPE Medical Information Co.,

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

The FDA Law Blog

OCTOBER 10, 2023

Implants subject to premarket approval (PMA), those eligible for the De Novo classification process, or those exempt from the 510(k) requirements fall outside the scope of this draft guidance. Implant devices are unique because they are designed for continuous implantation for a period of 30 days or more, as per 21 C.F.R.

Documentation 45

Documentation FDA Labelling Communication 45

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. This approach remains logistically complex, which builds the desire for allogeneic treatments that can be manufactured from unrelated donors on a larger scale. We must approach this on several fronts.

FDA 59

FDA Immunization 59

Roots Analysis

AUGUST 30, 2023

It’s a process that uses a combination of cells and biochemical and physicochemical factors to improve or replace biological functions. While xenogeneic cells carry a higher risk of viral infection, they have traditionally been used to manufacture epidermal tissue. Yes, you read it right! So, what is tissue engineering?

52

52

European Pharmaceutical Review

DECEMBER 22, 2022

Advances in mRNA technologies and cellular delivery systems coupled with their cost effectiveness, manufacturing simplicity and ability to target previously-undruggable pathways has limitless potential that could revolutionise medicine. Manufacturing time for mRNA therapeutics is also fast compared to antibodies or protein-based drugs.

Vaccines 106

Vaccines Immunization Hospitals 106

ISPE

NOVEMBER 10, 2022

Later in my career, I started to realize and apply myself to the many gaps that exist between the initial R&D of treatments and how to scale them in manufacturing to bring these products to patients. It is dynamic and often mysterious to understand the team work and collaboration of immunological cells. What is your vision for the industry?

Documentation 98

Documentation Compounding Hospitals Immunization 98

European Pharmaceutical Review

JANUARY 16, 2023

Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

Vaccines 126

Vaccines FDA Research Laboratories Documentation 126

ISPE

JULY 19, 2023

™ conference was held December 2022 in Vienna, Austria, in combination with the Aseptic Processing conference. ™ is now probably the most important industrial approach or pharma manufacturing, particularly for sterile and aseptic products. This drives the evolution from manufacturing to “smartfacturing.”

Documentation 98

Documentation FDA Labelling Communication 98

ISPE

MAY 25, 2023

It was therefore paramount in our selection process to identify and sponsor those proposals that reflected how success was achieved by developing best practices rather than simply digitizing existing inefficiencies. ™ discussion also continues on ISPE Engage, so do head on over and join the CoP. The Pharma 4.0™ Core to Pharma 4.0™

FDA 96

FDA 96

PharmaShots

MARCH 6, 2023

At UCB we embraced this ‘patient centricity’ approach too but we believe it’s time now to move towards a true partnership with patients at every step of the pharma value chain, from R&D to manufacturing. In fact, AI can bring value to patients at almost every stage of the drug development and treatment process.

Immunization 40

Immunization Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

ISPE

OCTOBER 27, 2022

As digital health sits at the intersection of technical, scientific, and regulatory disciplines involving medical devices, drugs, and biologics, the successful development of novel DHTs will require significant collaboration with health care stakeholders to overcome regulatory, technical, and life-cycle management challenges.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 28, 2022

The conference focused on the ongoing development and growth in these technologies, and featured speakers on a broad range of topics, including advanced manufacturing and how lessons learned from COVID-19 vaccine development can apply to biologics development. The Road to Advanced Manufacturing.

Vaccines 52

Vaccines FDA Immunization 52

ISPE

OCTOBER 27, 2022

As digital health sits at the intersection of technical, scientific, and regulatory disciplines involving medical devices, drugs, and biologics, the successful development of novel DHTs will require significant collaboration with health care stakeholders to overcome regulatory, technical, and life-cycle management challenges.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

European Pharmaceutical Review

DECEMBER 21, 2022

The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines. The healthcare industry is successful in innovating new treatment paradigms ranging from small molecular to biological therapeutics to personalised medicines.

Compounding 75

Compounding Pharmaceutical Companies Pharmaceutical Companies Packaging 75

ISPE

JULY 7, 2023

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. This article summarizes trends from the workshop and ponders next steps.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

The Thyroid Pharmacist

AUGUST 4, 2023

4] One of the key things to note is that this gene variation also prevents people from properly methylating, which is one of the body’s key detox processes that helps them get rid of toxins. 12] Even after optimizing TSH levels, one continued to experience miscarriages.

Insurance 105

Insurance Immunization Insurance Coverage Dosage 105

ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

European Pharmaceutical Review

FEBRUARY 23, 2023

Given the widely reported challenges of validation and qualification of microbiological methods, as well as lab compliance and keeping up with compendial amendments, I have steered away from these topics here. Currently entering the market are ‘robotic’ systems that perform environmental monitoring, cleaning and disinfection processes.

Dosage 95

Dosage Vaccines 95

PharmaShots

FEBRUARY 27, 2023

Chris Senanayake (CEO TCG Green Chem and CSO TCG Life Sciences) Dr. Chris shared his views on the Impact of Process Chemistry in Healthcare Sciences. The expertise and capabilities of TCG GreenChem were also highlighted along with TCG’s Continuous Flow Chemistry Lab (CFL) Platforms.

Packaging 40

Packaging Hospitals FDA Pharmaceutical Companies 40

Pharmaceutical Technology

FEBRUARY 24, 2023

It will combine the extensive capabilities of AbbVie with the new adeno-associated virus (AAV) engineering platform and the manufacturing capability of Capsida for identifying and advancing three programmes. Topic sponsors are not involved in the creation of editorial content.

Communication 52

Communication 52

Roots Analysis

AUGUST 8, 2023

The phospholipid bilayers continuously surround the dispersing aqueous media and create a vesicular system in response to mechanical shaking or heating. Another major challenge is the manufacturing of liposomes on large-scale since it is a multi-step and multi-test process and therefore, the innovation in this domain is essential.

Compounding 52

Compounding Vaccines 52

ISPE

SEPTEMBER 12, 2022

Deputy Director, Office of Manufacturing Quality. What’s the direction you see for ATMP manufacturing regulation? What controls need to be considered when patient-specific manufacturing has multiple products and different viral vectors in the same room? 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor.

FDA 52

FDA Documentation Communication 52

Roots Analysis

SEPTEMBER 22, 2023

In the continuous evolving landscape of healthcare, wearable injectors have emerged as transformative devices with the potential to redefine patient care. They are typically worn on the body, allowing patients to receive continuous or intermittent injections without the need for repeated manual injections or hospital visits.

Hospitals 40

Hospitals Dosage Chemotherapy Insurance 40

The Physician Pharmacist

OCTOBER 19, 2023

link] Our conversation with Dr. Smith covers a wide array of topics that will resonate with aspiring medical professionals and pharmacy enthusiasts alike: Applying to Medical School as a Pharmacy Applicant : Discover the unique considerations and challenges that pharmacy applicants face when making the transition to medical school.

Medical Schools 52

Medical Schools Hospitals Patient Care Community Pharmacies 52

The Thyroid Pharmacist

JULY 29, 2022

Breathing in pollutants is inflammatory, and triggers an immune response as the body tries to process out the toxins. This process puts the liver into overdrive, since chemicals of all kinds are metabolized by the liver. Indoor sources include flame retardants, upholstery, flooring and manufactured wood products, cleaning agents, etc.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52