NEWS & EVENTS

Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis

Excerpted from Drug Development & Delivery - January/February 2021 Issue.

The global pharmaceutical analytical testing outsourcing market was estimated at $6.1 billion in 2019 and is anticipated to register a CAGR of 8.3% through 2027, according to Grand View Research, Inc.1 Increasing demand for analytical drugs, biosimilars, and biopharmaceuticals are contributing to market growth. Other factors such as increasing investments in R&D for pharmaceuticals, rising demand for product safety and quality, and changing regulations for in vivo and in vitro tests are also expected to drive the demand for pharmaceutical analytical testing outsourcing services. Additionally, the development of combination products, biosimilars, and other innovative medicines has led to an increase in demand for specific types of pharmaceutical analytical tests, such as bioana­lytical testing, method development and validation, active pharmaceutical ingredient testing, and stability testing.

Topics: News & Events Editorials Analytical Testing Blogs

Risk Mitigation in the CDMO Space

Excerpted from Pharma's Almanac roundtable discussion in their Q4 2020 edition.

Although there is no such thing as a truly “crisis-proof” organization, how are you working to mitigate risks for future crises like the COVID-19 pandemic?

We’ve learned this year to expect the unexpected, and I don’t think any organization can be 100% “crisis-proof.” Still, at Alcami, we work very hard to be proactive and prepared for anything that may come our way. This effort applies beyond natural disasters and force majeure events to anything that may not go as planned. I’m confident anyone working in drug development would agree; unforeseen challenges will inevitably arise somewhere along the way.

At Alcami, our size enables us to adjust quickly and adapt to crises. For instance, this year we have embraced remote working and virtual solutions. Alcami employees have been amazingly creative and persistent in overcoming other challenges like supply chain issues that have come with the pandemic. We’ve maintained operations at all sites and even have a new sterile facility in RTP, North Carolina, on schedule to be operational in October.

Topics: News & Events Supply Chain Editorials Blogs

Prepping Fill/Finish Systems to Ensure Quality Output

Excerpted from BioPharm International's editorial titled, "Prepping Fill/Finish Systems to Ensure Quality Output."

A holistic approach to validation and quality assurance is essential.

Biologic drugs are highly valuable in treating diseases, and assurance of sterility and proper final product quality is essential. Appropriate testing must be conducted to ensure the filled vials, syringes, cartridges, etc. contain the correct quantity of sterile, contaminant-free product. Aseptic process simulations are crucial for the assessment of aseptic filling capabilities.

The best approach, agrees Maria Lacourt, director of manufacturing operations for Alcami, is to conduct a holistic assessment of all the controls for the process and work toward a facility design that ensures proper execution of the process. “Beyond meeting requirements for the relevant room classification, the right equipment must be identified that enables optimum performance within appropriate containment systems such as isolators, which ensure reduced intervention of operators during aseptic processing.”

Topics: News & Events Editorials Blogs

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