Tony Copley
The skin is a commonly used route of administration for pharmaceutical products for both systemic and topical action. Systemic therapies are delivered via transdermal drug products (TDPs) which release an active ingredient through the skin into the bloodstream. TDPs have high patient acceptability, enable steady, controlled delivery over a prolonged period and offer the additional benefit of avoiding first-pass metabolism in the gastrointestinal tract, which can damage the efficacy of certain drugs. As a result TDPs – which are often patches - are commonly used for the sustained delivery of, for example, hormones and treatments for smoking cessation.
Katrin Bomans, Markus Haberger, Lea Bonnington, Katharina Wagner, Tobias Kailich, Harald Wegele, Michael Mølhøj, Dietmar Reusch, Patrick Bulau
Chemical and post-translational modifications, including asparagine (Asn) deamidation, aspartate (Asp) isomerization, methionine (Met) oxidation, and crystallizable fragment (Fc) glycosylation, that occur in the marketed IgG1 antibody trastuzumab have been extensively reviewed. Recombinant monoclonal antibodies (mAbs) are exposed to process and storage conditions that might influence the rate and extent of these modifications.
Vanessa Cárdenas, Andres Roman Ospino, Rodolfo J Romañach
The effectiveness of near infrared (NIR) spectroscopy for monitoring and control of pharmaceutical manufacturing has been demonstrated in recent years.
João Henriques, Pedro Valente, Conrad Winters
Up to 90% of the drugs in the pharmaceutical pipeline are classified as poorly soluble according to the Biopharmaceutical Classification System.
Ellen V. Miseo, PhD
Optical spectroscopy is defined as the study of how matter interacts with electromagnetic radiation. The technique has been used as a tool to characterize samples in a variety of industries including pharmaceuticals. It can be used to determine metal content, the amount of active ingredient, the color of a sample, or the identity of the material.
The Pharmatek acquisition brings spray drying into Catalent’s portfolio of drug development technologies, and expands our formulation development and early phase manufacturing capabilities. With the addition of spray dried dispersions, Catalent now offers a comprehensive suite of bioavailability enhancement services, an important consideration for our customers given that most molecules in development do face bioavailability challenges. Following the acquisition, Catalent’s OptiForm Solution Suite, a science-driven screening approach, includes the full suite of technologies required to help identify an optimal formulation pathway for poorly soluble compounds.
Lisa Newey-Keane, Steve Carrington
Many medicines in routine use are particulate suspensions of an active pharmaceutical ingredient in a continuous liquid phase. Homogeneous dispersion of the key ingredient in such products is essential for uniform dosing. Understanding and controlling suspension instability is therefore crucial, to ensure that a product is both efficacious and safe.
Rosie McLaughlin, Leon Grother, Mathias Bayru
There are many patients for whom traditional tablets and capsules are not ideal dosage forms. It is difficult to persuade infants and very young children to swallow them, and they may pose a choking hazard. Older children may simply not want to take them. Adults can have difficulties, too, for example bariatric patients often find swallowing a challenge, and those who have Parkinson’s disease can be particularly badly affected.
Prasanna D. Khot, PhD, Christine E. Farrance, PhD
Microbial contaminants in pharmaceutical, food, and cosmetic
products can be potentially detrimental to human health. Release
of contaminated products can cause tremendous financial losses
to a company as a result of product recalls, fines, and complex
investigations to establish root cause. Not to mention, the significant
damage to a company’s reputation due to attrition of consumer
trust. To safeguard public health, regulatory agencies such as the
Food and Drug Administration (FDA), require pharmaceutical, food,
and cosmetic industries to manufacture and release products that
are not contaminated.1–3 As a result, companies implement an
Environmental Monitoring (EM) program to help ensure products
from their manufacturing facilities are free of microbial contamination.
Small molecule drug manufacturers have been applying semi-continuous processes with success for some years now. However, the key shift in acceptance arguably came this year as the Food and Drug Administration (FDA) approved a switch from batch to continuous processing for Janssen’s Prezista (darunavir) for the treatment of HIV-1 infection.
Robert Harris
The milling of drug substances to reduce particle size is a common
process used in the pharmaceutical industry. Reducing particle size
helps achieve uniform distribution of the drug when blended with
excipients, which is especially important for low dose products (drug
content
Jon S. Kauffman, PhD, Zsuzsa Lakos, Elena Dremina, John L. Snyder
Glycans, also known as oligosaccharides, are complex, highly branched carbohydrate structures composed of monosaccharide sugars such as fucose, galactose, mannose, N-acetylglucosamine and sialic acid (N-acetylneuraminic acid). They are typically found either attached to proteins (glycoproteins) or lipids (glycolipids). Glycosylation, the process of adding sugar units to a protein, is a common post-translational modification (PTM) in eukaryotic cells.
Patrick M. Hutchins, PhD
Historically, capture and subsequent culture of microorganisms has been the only technique available for accessing airborne contamination in cleanrooms and clean spaces. Like any analytical method this approach has fundamental limitations. For certain applications, such as in-process monitoring inside restricted Grade A spaces, growth-based methods present challenges to safe and efficient aseptic processing.
Gibraltar Laboratories was founded by Dr. Herbert N. Prince and is currently lead by Dr. Daniel Prince. Gibraltar Laboratories has been an industry leader for over 45 years providing world class independent testing for analytical chemistry, microbiology, molecular biology, sterilization and many other services. Offered among these services are a plethora of compendial and noncompendial testing methodologies including, but not limited to, sterility, LAL/endotoxin, microbial limits, antimicrobial efficacy, bioburden, environmental monitoring, antibiotics, analytical chemistry, custom/special projects and many more. Recently, Gibraltar Laboratories launched its first product, the SteriKit®.
Nigel Walker
Unlike small-molecule drugs, which are made from chemical starting materials with consistent compositions, biopharmaceuticals are produced from a mixture of animal, plant and synthetic sources. The potential for viral contamination is therefore real and must be addressed in the downstream drug manufacturing process. Doing so can be challenging, however; in many cases the potential viral contaminants may be unknown.
Sergei Dikler, Jens Fuchser, Meike Hamester, Joe Anacleto, Adam Hill
Accelerating the drug discovery process is a key priority for pharma-ceutical businesses around the world and the initial screening of very large compound libraries remains a critical first step. New technology and new applications of methods proven in other areas of research are constantly being assessed by discovery scientists. Everyone is looking for something to give them a competitive edge – more information, faster screening or deeper understanding.
Mike Schaefers
When thinking about factors that can impact the patient experience – especially regarding self-injection with pre-filled syringes – one might think of lifestyle, scheduling for self-care, patients’ attitudes toward their diagnoses, commitment to the treatment regimens, side effects and other factors that come with a drug. What these have in common is that each of those factors lies with the patients themselves.
Harshada Sant, MS
Mesalamine, 5-aminosalicylic acid, belongs to the class of antiinflammatory
agents and is used for the treatment of mild to
moderate active ulcerative colitis.