Remove Contamination Remove In-Vitro Remove Manufacturing
article thumbnail

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

They are often heat sensitive, membrane impermeable, subject to enzymatic degradation, and susceptible to microbial contamination (a factor which impacts manufacturing steps and quality considerations). Small molecules have known structures and are primarily chemically synthesized. ADME and Dosing Regimen.

article thumbnail

How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pharma Microbiology East Coast Conference – A Virtual Conference with Remote Access

pharmaphorum

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

article thumbnail

April’s Regulatory Focus: Professional and career development

The Pharma Data

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .

article thumbnail

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. What is the Medical Device Safety process?

article thumbnail

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. per share amounts). Reported Diluted EPS (1).

Vaccine 40
article thumbnail

Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Simplicity matters. Optimising development and scale-up.