NEWS & EVENTS

Roundtable Discussion with Pharma's Almanac: Greatest Drug Molecules to Impact Society & the Pharmaceutical Industry

Q: What two or three drug molecules do you identify as having had the greatest impact on society? What about on the pharmaceutical industry?

Over the last century, several groundbreaking inventions in drug discovery have contributed to a remarkable increase in life expectancy. Against this backdrop, it is difficult to identify three drugs having had the greatest impact on society. I’ve identified three that changed the course of medicine.

Insulin: The discovery of insulin revolutionized both the therapy and prognosis of diabetes. This is one of the most studied diseases in the history of medicine, dating back to Egyptian medical texts in 1552 BC. Ever since the isolation of insulin from pancreas tissue in 1923, numerous efforts were made to produce fully synthetic insulin, from rDNA human insulin in 1978 to various insulin analogs in 1996, aimed at optimizing the insulin absorption, distribution, metabolism, and elimination. The dream someday is for a needle-free delivery of insulin by oral route.

Topics: News & Events Editorials Blogs

Reducing Risk with Abuse‑Deterrent Formulations

Excerpted from Pharmaceutical Technology's editorial titled, "Reducing Risk with Abuse‑Deterrent Formulations."

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.

Possibly the most publicized and well-documented form of drug misuse and abuse has been that of opioids—prescription pain-relief medicines. The opioid crisis, which has impacted the global health community for several years, has paved the way for increased demand in abuse-deterrent formulations.

Abuse-deterrent formulations essentially have the potential to provide an effective way of reducing the capabilities of an end-user to abuse or misuse a medical therapy, while maintaining the drug’s clinical benefit. To explore the topic of abuse-deterrent formulations in more detail, Pharmaceutical Technology spoke with Angela Moore, scientist, Analytical Development, Alcami.

Topics: News & Events Abuse-Deterrence Editorials Blogs

Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions."

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process, including fill volume accuracy, plunger placement, material compatibility, and reduction in line loss. “Many of the prefilled syringe products in the contract manufacturing space are high value, low volume, so assessment of manufacturing capabilities with components selected by the client during the device design process is critical to ensuring our success during an individual manufacturing run or campaign,” says Jacquelyn Uribe, Vice President of Quality Operations at Alcami.

Topics: News & Events Editorials Parenteral Manufacturing Blogs

Editorial: Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas

Michael Reel, director of technical services at Alcami, and Quinn McGinnis, process engineer at Alcami, recently contributed to an article in Manufacturing Technology Insights titled Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas. In the article, Reel and McGinnis discuss solutions to pharmaceutical packaging challenges through straightforward case studies.

Even well-designed product formulations can fail if it is contained in inappropriate packaging. How does one decide which packaging to use for a product?

Foremost, packaging has to protect the product from degradation and damage. Material compatibility, water activity, and dynamic vapor sorption testing, and forced degradation studies during development are key in identifiying the risks. different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered prodcuts may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves or amber-colored glass for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. These are just a few examples of the ways packaging is used to protect the product from its environment or handling. Early evaluation of the formulated product is pivotal to selecting the right mitigation strategy.

Topics: Editorials Packaging Blogs

The Changing R&D Landscape: Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs)

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. After a precipitous fall in new drug approvals during the last two decade of the 20th century, there has been a gradual recovery going into the second decade of the 21st century.Figures 1 and 2 map drug approvals by molecule type and route, excerpted from the publication by Ouyang et al1 based on 34,673 drug products approved by the FDA over a 37-year period from 1980 through 2017. The number of biopharmaceutical products show a considerable growth accounting for nearly a quarter of the new molecular entities approved in 2017. While oral delivery route (62%) is still the most prevalent amongst marketed drug products, alternative adminstrations such as injection (22%), cutaneous, mucosal, inhalation, and others are making up a greater percentage as the industry works to improve bioavailability and subsequent efficacy.

Topics: Regulatory Compliance Editorials Development

Editorial: Considerations for Approval of Biosimilars

Alcami recently contributed to a special feature in the August / September issue of Chemicals Knowledge magazine, titled "Considerations for Approval of Biosimilars."

Biosimilars are sometimes incorrectly considered equivalent to a generic small molecule therapeutic, but for a biologic drug product, the clinical and regulatory pathways are quite different. Alcami Commercial Development Manager Cheryl Johnson explains the distinct differences in the FDA’s definition, development strategy, and regulatory approval pathways.

Topics: Regulatory Compliance Biologics Editorials Parenteral Manufacturing

eBook: Analytical Testing in Drug Development

Alcami recently contributed to an eBook produced by Drug Development and Delivery. The eBook, titled "Analytical Testing in Drug Development," features four companies and explains how they each help the pharmaceutical and biotech industries comply with drug development regulatory requirements. 

Angela Moore, abuse-deterrence studies subject matter expert at Alcami, contributed to the eBook. Her article focuses on considerations for abuse-deterrent Category 1 studies as well as standard syringeability studies.

Topics: Regulatory Compliance Abuse-Deterrence Editorials Development

Editorial: Designing a CMC Strategy for Accelerated Development of Biotherapeutics

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Designing a CMC Strategy for Accelerated Development of Biotherapeutics."

As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity. There are many drivers to accelerate development.

Topics: Regulatory Compliance Biologics Editorials Parenteral Manufacturing

Editorial: Novel Therapies Roundtable Discussion

Alcami recently contributed to a roundtable discussion in Pharma's Almanac magazine, answering the question:

"What truly novel therapies in the earliest stages of discovery and development do you believe will have a significant impact in the future?" 

The article shares insights to this question from Alcami, along with other companies in the biologics space.

Topics: Biologics Editorials Development

Editorial: Overcoming the Opioid Overdose Crisis

Alcami recently contributed to an article in the Greater Wilmington Business Journal titled, "Overcoming the Opioid Overdose Crisis."

Our community has come together, like many others, to combat the opioid crisis. Several local agencies have rallied to create impactful community resources. A 2016 survey by Castlight, which listed Wilmington, NC as the #1 city for opioid abuse in the United States, was a wake-up call to the level of severity this community has been affected by opioid-related fatalities and hardships. At Alcami, we work with our clients to develop abuse deterrence medicines to help combat this nationwide epidemic that hits home, even here in Wilmington.

Topics: Abuse-Deterrence Editorials